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Regulatory Affairs Lead - Manager/Senior Manager/ Ophthalmology Location: Remote Type: Full-time Compensation: $165,000 Position Summary Our biotech client is seeking a hands-on Regulatory Affairs professional to support the development of its ophthalmology programs in a small, fast-paced biotechnology environment. This role requires an individual who is equally comfortable developing and proposing regulatory strategies and executing the detailed work required to implement approved strategies. Reporting to the Chief Medical Officer, the Regulatory Affairs Lead will work closely with R&D leadership and Clinical Development, Clinical Operations, CMC, Nonclinical, Quality, Pharmacovigilance, Medical Affairs, and external regulatory consultants to develop regulatory recommendations and translate R&D leadership-approved regulatory strategies into executable plans and submissions. Regulatory recommendations will be developed in the context of the overall product development plan and corporate objectives. The successful candidate will have broad regulatory experience and a demonstrated ability to work across multiple areas of Regulatory Affairs without relying on the specialized infrastructure typical of a large pharmaceutical company. This individual will be expected to roll up their sleeves and take ownership of regulatory deliverables from planning through submission, and independently drive approved regulatory activities and deliverables to completion. Key Responsibilities • Develop and propose global regulatory strategies and recommendations supporting clinical development, registration, and lifecycle planning for ophthalmology programs. Work with R&D leadership and cross-functional teams to refine these recommendations and execute regulatory strategies following R&D leadership approval., • Translate approved regulatory strategy into detailed regulatory plans, timelines, health authority interactions, and submission activities, ensuring continued alignment with the clinical development plan and corporate objectives, • Take hands-on ownership of regulatory submissions, including planning, authoring, coordinating, reviewing, and driving documents through finalization and submission., • Prepare and manage US regulatory submissions and interactions, including INDs, IND amendments, annual reports, safety-related submissions, briefing packages, requests for designations, responses to information requests, and regulatory correspondence, • Develop recommendations for the objectives, content, and regulatory approach for health authority interactions and, following alignment with R&D leadership, prepare and coordinate meeting requests and briefing packages, including Pre-IND, Type B, Type C, Type D, End-of-Phase 2, and other FDA interactions, • Prepare and support expedited and special designation requests, including Orphan Drug, Fast Track, and Breakthrough Therapy Designations, as applicable and consistent with the approved development strategy, • Support global clinical trial applications and development activities, with particular initial emphasis on the EU and UK, including CTAs, substantial modifications/amendments, responses to health authority questions, and maintenance of ongoing clinical trial authorizations, • Support development of global registration submissions, including BLAs and MAAs, as programs advance toward registration, • Coordinate regulatory activities with external consultants/contractors as appropriate, CROs, regulatory vendors, and submission/publishing resources while retaining internal ownership of regulatory deliverables, timelines, and execution, • Serve as a day-to-day regulatory partner to Clinical Development, Clinical Operations, CMC, Nonclinical, Quality, Pharmacovigilance, Technology, and other functions, providing regulatory analysis and recommendations and escalating significant strategic decisions to R&D leadership for alignment and approval, • Review protocols, investigator brochures, clinical documents, CMC and nonclinical documentation, safety documents, and other development materials for regulatory consistency and compliance with responsibility for generation of final formatted documents using company approved templates, • Maintain regulatory correspondence, submission histories, health authority commitments, regulatory trackers, agency questions and responses, and other regulatory records necessary to support the development program, • Monitor evolving FDA, EMA, MHRA, ICH, and other relevant regulatory requirements, assess their potential impact on development programs, and recommend appropriate actions to R&D leadership., • Identify and escalate regulatory risks to R&D Leadership, develop practical options and recommendations, and support implementation of the approved approach, • Develop, maintain, and/or improve Regulatory Affairs processes, templates, working practices, and SOPs that are fit for purpose and scalable as the organization grows, • Support regulatory due diligence, partnering activities, and other business-development activities as requested, • Perform both strategic and operational Regulatory Affairs activities as needed in a lean organization; no task should be considered too detailed or too operational when required to move a program forward Qualifications • Bachelor's degree in life sciences, pharmacy, regulatory affairs, or a related scientific discipline; advanced scientific or healthcare degree preferred, • Typically 10-15+ years of progressively responsible Regulatory Affairs experience, with demonstrated depth and breadth of hands-on regulatory experience commensurate with a seasoned Manager/Senior Manager-level role, • Demonstrated experience working in a small or mid-sized biotechnology/pharmaceutical company, or equivalent experience operating with significant individual ownership and limited regulatory infrastructure, • Demonstrated hands-on experience preparing and managing regulatory submissions rather than solely providing strategic oversight or managing work performed by others, • Experience supporting clinical-stage drug or biologic development, including IND maintenance and FDA interactions, • Experience with several of the following required: FDA Pre-IND meetings, Type B/C/D meetings, End-of-Phase 2 meetings, IND amendments and annual reports, Orphan Drug Designation, Fast Track Designation, Breakthrough Therapy Designation, and registration planning., • Practical experience supporting EU and/or UK clinical development and regulatory submissions strongly preferred. Experience with EMA, EU Clinical Trials Regulation/CTIS, MHRA, PIP activities, or other ex-US regulatory processes is an advantage, • Experience coordinating simultaneous or sequential regulatory activities across multiple regions, • Experience with biologics development strongly preferred, • Ophthalmology experience, including anterior segment, ocular surface, glaucoma, or related areas, is strongly preferred, • Strong knowledge of FDA regulations, ICH guidelines, and applicable global regulatory requirements., • Excellent scientific and regulatory writing skills, with demonstrated ability to synthesize complex clinical, nonclinical, and CMC information into clear regulatory documents., • Ability to work closely with a scientific-medical writer when avaiable, • Strong organizational and project-management skills, including the ability to independently manage multiple regulatory deliverables, deadlines, consultants, and cross-functional contributors., • Comfortable working in an entrepreneurial, highly collaborative environment with limited hierarchy, potential for changing priorities, and a high degree of personal accountability, • Demonstrated ability to identify what needs to be done, take ownership, and drive activities to completion without requiring extensive infrastructure or administrative support, • RAC certification is a plus but is not required

POSITION SUMMARY: The Proposal Writer (Business Operations Manager) is a pivotal role within Piramal Pharma Solutions, responsible for driving the creation of high-impact, technically robust, and strategically aligned proposals. This position interfaces with internal and external stakeholders to evaluate opportunities, define project scopes, and deliver proposals that win business and advance organizational goals. The ideal candidate combines deep technical expertise with exceptional strategic thinking, ensuring proposals are not only accurate and compliant but also innovative and competitive. To perform this position successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required: • Shall adhere to all applicable regulatory requirements, including FDA, EPA, OSHA, and related safety, health and environmental procedures, policies and practices., • Consistent support and practice of all Piramal Pharma Solutions mission, vision, and values., • Identify and protect the original technical information as part of the company property. KEY RESPONSIBILITIES Technical Evaluation & Scope Definition • Analyze RFPs and client requirements, collaborating with subject matter experts (SMEs) at site and in Global Functions to clarify technical needs and project parameters., • Lead technical discussions to ensure proposals reflect the latest scientific, engineering, and operational capabilities of the site(s)., • Integrate complex technical data and regulatory requirements into proposal documents for pharmaceutical development and manufacturing projects. Strategic Proposal Development • Develop proposal strategies that align with business objectives, market trends, and client expectations., • Identify and capitalize on strategic opportunities, leveraging data analytics and business intelligence to strengthen proposal positioning., • Recognize and respond to trends in the business pipeline, proactively shaping proposal content to address emerging client needs. Project Management & Collaboration • Coordinate cross-functional teams (Business Development, Technical, Finance, Manufacturing) to gather information, set priorities, and meet proposal deadlines., • Drive interdepartmental communications to define project scope, budget, and timelines., • Build and maintain strong relationships with internal teams and external clients throughout the proposal lifecycle. Quality Assurance & Compliance • Ensure proposals adhere to regulatory standards (FDA, EPA, OSHA) and internal quality benchmarks for readability, consistency, and flow., • Maintain proposal databases and Salesforce, ensuring accuracy and accessibility of records., • Organize and manage pricing files and related documentation related to proposal activities. Continuous Improvement • Implement best practices in proposal writing, leveraging templates and standards to improve efficiency and outcomes., • Provide technical support and host client visits, showcasing organizational capabilities and fostering trust. KEY INTERACTIONS. • Internal: Site Leadership Team; Business Development; Science Collective, • External: Customers EDUCATION/EXPERIENCE. • Advanced degree in technical discipline preferred (Chemistry, Biology, Engineering or related); bachelor’s degree in engineering, Chemistry, Life Sciences, or related technical field a must. Master’s in business administration also a plus., • Prefer knowledge in Active Pharmaceutical Ingredients (API), Formulation OSD, or Fill Finish, • Minimum 3-5 years’ experience in pharmaceutical manufacturing with desired 3+ years in services quote development., • Demonstrated expertise in technical writing, project management, and strategic business development., • Strong proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, MS Project)., • Proficiency with Salesforce, • Experience with regulatory compliance and quality assurance in a pharmaceutical environment. JOB COMPETENCIES. • Technical Acumen: Ability to understand and communicate complex scientific and engineering concepts., • Strategic Thinking: Skilled in analyzing market trends, client needs, and business data to inform proposal strategy., • Communication: Excellent verbal and written communication skills, with the ability to convey technical information clearly., • Relationship Building: Proven ability to build and maintain productive relationships with colleagues and clients., • Organization & Time Management: Strong organizational skills, attention to detail, and ability to manage multiple priorities under tight deadlines.

This is a W2 contract opportunity.Duration: 6 months (may extend).Hours: 40/week (flexible depending on experience level and availability).We are seeking an experienced, strategic.Digital Content Writer / SEO Specialist.The ideal candidate combines strong editorial judgment with hands-on SEO and AI-

🚨 Senior Medical Writer – Publications | Remote (US) Ready to shape high-impact scientific publications that help advance healthcare ? An award-winning, independent medical communications agency is looking for a Senior Medical Writer (Publications) to join its growing team. This is an opportunity to work alongside leading scientific experts, pharmaceutical and biotech clients, and a collaborative group of strategists, editors, and medical writers dedicated to delivering exceptional scientific communication s. What you'll be doi ng:• Lead the development of publication deliverables, including manuscripts, abstracts, posters, oral presentations, and congress materia ls.• Translate complex scientific and clinical data into clear, accurate, and engaging content for healthcare professional audienc es.• Partner closely with clients, key opinion leaders (KOLs), and cross-functional internal teams to drive publication strategy and executi on.• Ensure all materials are scientifically rigorous, publication-ready, and compliant with industry guidelines and timelin es.• Mentor junior writers and contribute to the overall scientific excellence of the te am. What we're looking for:✔ Advanced life sciences degree (PhD, PharmD, MD, or equivalent prefer red)✔ Strong medical communications agency experience with a focus on publicat ions✔ Demonstrated expertise writing manuscripts, abstracts, posters, and congress con tent✔ Exceptional scientific writing, storytelling, and project management sk ills✔ Experience collaborating directly with pharmaceutical or biotech clients and external exp erts What's on o ffer:✨ Fully remote wo rking✨ Competitive compensation and comprehensive ben efits✨ A highly collaborative, science-first cu lture✨ Diverse therapeutic areas and innovative publication pro grams✨ Clear opportunities for professional growth and career progre ssion

Strong editing, proofreading, research, organization, and project-management skills. Healthcare, health services, or other regulated-industry writing experience.

Excellent writing, editing, and proofreading skills with attention to detail. This role involves writing content for law firm websites, generating content ideas that align with law firm objectives, and researching legal topics to provide accurate and trustworthy information. As a member of our writi

Associate Medical Director – Freelance Location: Remote Summary At VML, we are a beacon of innovation and growth in an ever-evolving world. Our heritage is built upon a century of combined expertise, where creativity meets technology and diverse perspectives ignite inspiration. With the merger of VMLY&R and Wunderman Thompson, we have forged a new path as a growth partner that is part creative agency, part consultancy, and part technology powerhouse. Our global family encompasses more than 30,000 employees across 150+ offices in 64 markets, each contributing to a culture that values connection, belonging, and the power of differences. Our expertise spans the entire customer journey, including communications, commerce, consultancy, CRM, CX, data, production, and technology. We deliver end-to-end solutions that result in transformative work. Who We Are Looking For VML is seeking a Freelance Associate Medical Director to support a major North American pharmaceutical client. This is a unique opportunity for an experienced scientific/medical writer to join a growing team focused on developing medical manuscripts and high-science, long-form content for scientific, medical, and healthcare professional (HCP) audiences. Content will support publications, journals, and digital destinations for a leading global pharmaceutical client. The ideal candidate will bring an innate curiosity about evolving medical therapies, treatment approaches, and scientific advances, along with demonstrated expertise in developing manuscripts and publication-focused tactics that leverage therapeutic-area and target-audience insights. This role will focus primarily on non-promotional, project-based scientific communications, including manuscripts and other long-form content designed to communicate and contextualize advances in oncology therapies for the broader medical community. As a member of the Medical Strategy and Publications team, the Freelance Associate Medical Director will be responsible for developing, writing, reviewing, and editing medical communications deliverables based on a thorough understanding of the client's products, therapeutic areas, scientific literature, and competitive landscape. What You’ll Do • Demonstrate a strong understanding of oncology-focused products, therapies, disease states, and the evolving treatment landscape., • Develop, write, edit, and scientifically review medical manuscripts and other long-form scientific content for publications and HCP-focused audiences., • Bring a portfolio of published work, including peer-reviewed or advanced medical manuscripts and other relevant scientific communications., • Partner with internal teams—including Account, Project Management, Editorial, Creative, and Strategy—as well as client stakeholders to develop scientifically rigorous content that supports program objectives., • Work closely with the Senior Medical Director to oversee multiple projects from a scientific and strategic perspective, including the development and execution of medical communication tactics, manuscripts, and publications., • Participate in strategic planning, scientific reviews, status meetings, and project discussions with internal and client teams as needed., • Develop and maintain a deep understanding of assigned products, disease areas, treatment paradigms, scientific literature, and competitive activity., • Conduct literature reviews and scientific research as needed to support accurate, evidence-based content development., • Identify and communicate important scientific, medical, publication, and regulatory developments that may affect assigned programs., • Provide scientific and strategic recommendations to strengthen existing programs and identify opportunities for new or expanded work., • Collaborate with Editorial to resolve grammatical, stylistic, scientific, and editorial issues and ensure content meets established quality standards., • Apply a proactive, solutions-oriented approach to assignments, anticipating challenges and helping teams develop effective solutions., • Ensure all deliverables are scientifically accurate, appropriately referenced, audience-relevant, and aligned with project objectives and applicable industry standards. Skills and Qualifications • Advanced scientific degree preferred (PhD, MD, PharmD, or equivalent)., • 3+ years of experience in medical communications, medical writing, publication development, or a related field; oncology experience strongly preferred., • Demonstrated experience developing medical manuscripts and other long-form scientific communications., • A portfolio demonstrating published work, preferably including peer-reviewed manuscripts or other advanced medical publications., • Strong understanding of medical terminology, scientific literature, clinical research, and evidence-based communication., • Excellent scientific writing, editing, and proofreading skills, with meticulous attention to detail., • Ability to translate complex scientific and medical information into clear, accurate, and compelling content for sophisticated medical and HCP audiences., • Ability to manage multiple projects, priorities, and deadlines while maintaining a high level of scientific and editorial quality., • Ability to work effectively in a highly collaborative, multidisciplinary environment., • Strong self-motivation, initiative, and adaptability, with the ability to thrive in a fast-paced, dynamic, and highly detail-oriented environment., • Strong communication and presentation skills, with the ability to clearly articulate scientific concepts and recommendations to both internal teams and clients., • Proficiency with Microsoft Office and other relevant digital, research, reference-management, and collaboration platforms. Who You Are A Builder | An innovator who brings people together and creates momentum around ideas. You have an innate ability to build relationships, connect perspectives, and move projects forward. Open and Collaborative | Our team is close-knit and supportive, and we frequently work through complex and evolving challenges. You embrace collaboration and contribute to an environment that is inclusive, constructive, and encouraging across disciplines. An Experimenter | You are comfortable exploring new ideas and approaches rather than relying solely on established paradigms. You see technology as an opportunity to enhance creativity, efficiency, and scientific communication. Optimistic and Resilient | You approach challenges with curiosity and determination, finding practical solutions and maintaining a positive, constructive mindset when navigating ambiguity or changing priorities. A Team Player | You understand that successful teams require flexibility and a willingness to contribute wherever needed. You are comfortable wearing multiple hats, supporting colleagues, and doing what is necessary to deliver high-quality work.