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QA Regulatory Manager Site‑based with flexibility for some remote working in the long‑term Locations: Flexible - can be based out of Sheffield, Preston, Stoke‑on‑Trent or Manchester Are you an experienced QA and Regulatory professional ready to take on a pivotal leadership role within an exciting growing business? Our client is looking for a QA Regulatory Manager to oversee regulatory affairs for the UK business and assist with QA projects. Reporting directly to the Head of Quality, this is a key strategic position interfacing with Quality Assurance, Regulatory Affairs, Operations and external regulators. You’ll play a critical role in shaping quality systems, ensuring inspection readiness, and supporting the development and supply of Investigational Medicinal Products (IMPs). What you’ll do: • Provide QA and regulatory leadership across all UK 6 facilities, ensuring consistent application of GMP, GDP and MHRA requirements., • Act as the regulatory lead for IMP development activities, including review and approval of IMPDs, clinical trial quality documentation and supply processes., • Lead interactions with MHRA and other regulatory bodies, supporting inspections, audits, responses and ongoing compliance commitments., • Ensure site licences, variations and regulatory submissions remain current and aligned with operational activities., • Harmonise and strengthen quality systems across multiple sites, covering deviations, CAPAs, change control, documentation and risk management., • Provide QA project support for product development, technology transfer and validation activities within sterile production environments., • Review and approve quality documentation, including SOPs, validation protocols, batch records and development reports., • Serve as subject matter expert for aseptic GMP, IMP manufacture and regulatory expectations. What you’ll bring: • Proven Regulatory Affairs experience within sterile manufacturing or aseptic environments (5 years+), • Proven QA management experience, • Hands‑on experience supporting IMP development, clinical trial supply and IMPD preparation/review., • Strong working knowledge of UK/EU GMP, MHRA regulatory requirements and GxP compliance., • Background in regulatory inspections, audits and authority interactions., • Ability to work effectively with manufacturing, QC, development and clinical teams., • Degree in a scientific discipline (or equivalent experience); further QA/regulatory qualifications are an advantage., • Excellent communication skills, able to influence and collaborate at all levels. Why Apply? This is a rare opportunity to take on a high‑impact role within a specialised and mission‑driven aseptic pharmaceutical operation. You’ll shape the regulatory framework supporting both commercial products and innovative clinical development programmes—while working with a collaborative, highly skilled team committed to improving patient outcomes. Key Words: Regulatory Affairs, RA, QA, quality assurance, manager, senior, supervision, supervisor, leader, lead, IMP, clinical, commercial, GMP, sterile, aseptic, injectables, injection, terminal sterilization, radiopharmaceutical, radiopharma, nuclear medicine.

Job offer For our dynamic growing, innovative Brands division within an already established big generic International pharmaceutical company, we are looking for an experienced Medical Affairs field professional who dares to look outside the clear-cut frames of a common big pharma MSL job and who wants to operate in an autonomous entrepreneurial way. You will be working in the area of dermatology and more specifically in the area of alopecia areata where a product is expected to receive UK market authorization later this year. You will be responsible for the Medical Affairs strategy and Execution of the Medical activities in the UK, but also work closely with Market Access, Sales and Marketing colleagues. Your work is more field than office oriented and you report to the EU Medical Manager. The European Management team is located at different places in Europe and the European offices are in Amsterdam, Netherlands. Major tasks & responsibilities • Development Medical Affairs strategy and execution Medical scientific projects like scientific publications and advisory boards at country level, • Identify and develop peer-to-peer relationships with country KOLs, as well as other influencers and leaders of the scientific and healthcare community, utilizing scientific and medical evidence-based information, • Strategically prepare and support the development, launch of products through scientific exchange. The recently launched product is indicated in moderate to severe dry eye disease., • Lead the process to approval of investigator-initiated trials and monitor progression, • Ensure the appropriate dissemination of clinical and scientific information regarding marketed and pipeline compounds in a timely, compliant and ethical manner, • Develop links with and support national, regional and local networks in Dermatology (Alopecia), • Communicate the latest emerging data to identified experts, response to unsolicited healthcare professional inquiries, • Supporting colleagues in organizing HCP events by providing medical content to speakers. Key Performance Indicators/result areas • Awareness level of Sun pharma medical treatments with among treating Dermatologists in country and among national KOL community, • National Peer-to-peer program planning and implementation, • Setting up and successfully lead local engagement plan, • Planning and implementing national symposia (stand alone or within relevant congresses), • Local medical publications, • Scientific presentations in hospitals, • Prepare prioritized target list, • Number of meetings within target Qualifications, Knowledge, Experience & Skills Education Qualifications (Graduate- Post Graduate) • Mandatory – (bio) medical (scientific) academic degree, • Driver’s license Work experience • Mandatory - Minimum of three years of MSL or Medical Manager experience in the innovative pharmaceutical industry, • Mandatory – based in UK, Native English Technical skills/job specific competencies • Good scientific level, • Strategic thinking, • Knowledge of regulatory environment and compliance., • Good teaching and Presentation skills, • Flexibility, patience, • Positive creative mindset to challenges, • Likes to interact with HCPs and being in the field (vs desk) Leadership Competences Execution Focus • Drives performance by efficiently planning, organizing and managing action plans, • Finds ways to overcome challenges and obstacles so that assignments are completed and goals are met., • Depicts a sense of urgency for solving problems and getting work done in the most efficient model, • Constantly monitors results to make sure solutions were effective and acts if resolution has not been accomplished Accountability • Takes responsibility and owns up to all activities and personal actions, • Executes with agility, without compromising on core values, • Follows through and implements agreed decisions within agreed timelines consistently, • Clearly defines accountability within the team and drives them to achieve high performance standards Collaboration • Builds strong internal networks and communicates across departments and functions to meet business objectives, • Proactively contributes to the success of other departments and shares credit., • Does not hesitate to seek help, • Focuses on overall business value to Sun over own department/function, • Is culturally sensitive and comfortable working in an international context Customer Centricity • Understands and responds to customer/ stakeholder needs, • Develops positive long-term relationships with customers/ stakeholders, • Displays an entrepreneurial mind-set and identifies opportunities and ways to stay ahead of competition

Regulatory Affairs Manager (EU) | Leading Pharma We’re hiring a Regulatory Affairs Manager to support products in development and post-MAA, contributing to EU regional clinical regulatory strategy and supporting EU Regulatory Leads across global development and lifecycle activities within a leading pharmaceutical organisation. What you’ll do • Lead and support planning, coordination, and preparation of EU regulatory submissions, • Contribute to EU clinical regulatory strategy and risk assessment/mitigation, • Provide regulatory guidance across R&D and product lifecycle activities, • Support and participate in EU Health Authority interactions and meeting preparation, • Help ensure post-approval compliance and inspection readiness What we’re looking for • 5+ years’ pharma/biotech experience, including Regulatory Affairs experience, • EU regulatory submission experience (clinical and/or lifecycle), • Strong understanding of EU regulations, guidelines, and submission processes, • Excellent communication, organisation, and stakeholder management skills, • Life/Health Sciences degree (preferred) About Planet Pharma: Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering. Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing. We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age. Please click ‘apply’ or contact Finlay Keyworth (Recruiter II) at Planet Pharma for more information: E:

It serves as the primary point of contact for regulatory and product safety matters, supports business decisions through impact assessments, and drives harmonization of stewardship processes, SDS, labeling, and regulatory projects. This role provides product stewardship and regulatory support for th

The ideal candidate will have a degree in a scientific discipline and experience in regulatory affairs, particularly in writing regulatory documents. A charitable organization focused on cancer research is seeking a Regulatory Affairs Manager in Sheffield. This role involves providing expert regulat

Regulatory Affairs Department,. The Regulatory Affairs Specialist role provides.

We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing. Regulatory Affairs Manager (EU) | Leading Pharma. MAA, contributing to EU regional clinical regulatory st

Title : Regulatory Affairs Associate - Regulatory Operations - Publishing. Freyr is a global Regulatory Solutions and Services organization supporting Life Sciences companies across Regulatory Affairs, Clinical, Safety, and Compliance. We partner with leading pharmaceutical, biotechnology, and medic

You will sit within the wider Regulatory Affairs team and will work very closely with the Regulatory Affairs Director for Colonis. This is a dedicated Regulatory Affairs Manager role supporting Colonis, a Clinigen Group company. To support our growth, we are seeking a dynamic, detail orientated and

Experience in Regulatory Affairs within the pharmaceutical industry. This role suits experienced regulatory professionals. Support regulatory capability and process development.

You will oversee regulatory project management and act as a key partner to global Regulatory Affairs teams, R&D, Clinical Affairs, and wider cross‑functional groups. As Regulatory Affairs Manager, you will define and deliver UK/EU regulatory strategy across a diverse portfolio of products, includi

Associate Director – Regulatory Affairs CMC. CMC regulatory strategy across development and lifecycle programs. CMC regulatory documentation and CTD Module 3.

Senior Regulatory Affairs Contractor / Consultant. Strong focus on process development, documentation, and regulatory compliance standards. Experience supporting organisations expanding beyond the UK/EU, with awareness of broader regulatory considerations.

We're looking for an experienced Regulatory Affairs Manager to focus on financial crime related regulatory engagements, ensuring communication with external regulators is transparent, compliant, and efficient. The Regulatory Affairs team builds transparent relationships with regulators to keep Revol

The Regulatory Affairs Specialist reports into RA leadership and is responsible for regulatory compliance, regulatory submissions, and supporting regulatory planning and execution across the organisation. We are seeking a Regulatory Affairs Specialist with hands-on experience in software medical dev

As a Principal or Senior Regulatory Affairs CMC Consultant, you will play a key leadership role, providing high-level regulatory and technical guidance for complex therapeutics. Represent clients in interactions with regulatory agencies and provide solutions to regulatory challenges and objections.

Freyr's client is seeking a Regulatory Affairs Manager to fill a critical role in supporting development and execution of global regulatory strategies for investigational submissions, with a focus on EU and UK CTR. Provide critical support in developing global regulatory strategy, planning, and exec

You’ve built experience in a regulatory or quality-focused admin role, and you take pride in keeping things accurate, organised, and audit-ready. You’ll support the quality and regulatory teams with keeping their processes and procedure in good shape. Ensuring processes related to quality/regula

Are you an experienced regulatory professional looking to shape global strategy and influence product development at an international level? This is an exciting opportunity to a global Pharmaceutical Manufacturing organisation as an Associate Director, Global Regulatory Strategy. Provide strategic i

Location: UK (multi-site flexibility)Industry: Medical DevicesEmployment Type: Full-time, PermanentA leading UK-based medical device manufacturer is seeking an experienced Risk Management Specialist to join its Quality & Regulatory team. Halianis currently recruitingfor an experienced Reg affairs Ri

A leading medical device firm in the United Kingdom is seeking a skilled Regulatory Affairs Manager. In this role, you will lead the Regulatory Affairs team and be responsible for managing registrations, certifications, and compliance. This position requires a strong background in medical device reg

Keep the heartbeat of innovation running and join our client in this Regulatory Affairs Labelling position and ensure cutting-edge pharma operations never miss a beat!. Proclinical is seeking a Regulatory Labelling Manager to support the development, optimization, and implementation of regulatory la

This role offers the chance to work with leading banks on regulatory reforms, focusing on financial crime and compliance issues. Ideal candidates will have regulatory expertise, strong analytical skills, and experience in AML.

Senior Regulatory Affairs and QA Specialist - Medical Devices. Senior Regulatory Affairs & Quality Assurance Specialist. Biomedical Engineering, Life Sciences, Regulatory Affairs, or similar).

A leading organization in regulatory affairs is seeking a Regulatory Affairs Manager based in the United Kingdom. Responsibilities include tracking employee training, maintaining regulatory documentation, and liaising with regulatory agencies.

An international medical device company based in the United Kingdom is seeking a Director of Regulatory Affairs. The ideal candidate will possess over 15 years of experience in regulatory affairs, preferably in the medical device sector, and have proven leadership abilities across multiple countries

We’re looking to hire a Legal Counsel to join our Public Affairs & Regulatory team. Supporting the Public Affairs team on advocacy initiatives, including assisting with: consultation responses to regulators and policymakers, drafting amendments to legislative proposals, determining policy position

A leading regulatory solutions provider in the United Kingdom is seeking a Regulatory Affairs Manager to enhance quality management systems. The ideal candidate will have a Bachelor's degree, 2 years of experience in regulatory affairs, and knowledge of FDA and ISO standards. This position will ensu

A fast-growing tech company in Greater London seeks a Legal Counsel to join their Public Affairs & Regulatory team.

The Regulatory Affairs Lead provides expert telecoms and digital regulatory guidance across these lines of business, and acts as a key subject‑matter expert (SME) in implementing the Group Telecom Regulatory Compliance Policy. Responsible for the delivery of telco regulatory compliance advice to t

Head of Spectrum & Regulatory Affairs. You will define and execute the regulatory and spectrum strategy required to secure and protect ITU filings, enable international market access, and ensure compliance across all operational jurisdictions. Oversee technical studies supporting regulatory submissi

G&L have multiple positions available for Regulatory Affairs Manager. Regulatory Affairs within the pharmaceutical industry. Your work ensures our products continue to meet global regulatory expectations throughout their lifecycle.

Cancer Research UK is looking for an experienced regulatory affairs professional to join our Centre for Drug Development as a Regulatory Affairs Manager. Ability to apply specialist regulatory knowledge and experience to support the regulatory aspects of early phase drug development in the Charity.

A prominent pharmaceutical company in the United Kingdom seeks a Regulatory Affairs Specialist to provide full regulatory support for products. The ideal candidate will have significant experience across the product lifecycle, particularly with CMC regulatory submissions.

We are looking to hire a Legal Counsel to join our Public Affairs & Regulatory team. An interest in politics and current affairs, keeping informed about the regulatory environment. Your primary focus will be to help maintain Trustpilots reputation as a trusted and compliant platform by navigating a

Maintain and organize regulatory documentation including job descriptions and resumes regulatory submissions correspondence with regulatory agencies and regulatory tracking databases. Collaborate with regulatory affairs teams to ensure alignment of training programs with current regulatory expectati

As Director, Litigation, Competition & Regulatory Affairs, EMEA, you will be the primary litigation, competition and regulatory counsel for the Sony Interactive Entertainment (SIE) business in the EMEA region, including Europe and the UK. You will handle a wide range of litigation matters, working c

Tether is seeking an experienced and visionary Head of Regulatory Affairs to design and execute global regulatory affairs strategies for our Tether Data business vertical. Policy Advocacy, Monitoring, Analysis and Guidance: Monitor, analyse and communicate changes in global regulatory policies, and

Maintain and organize regulatory documentation including job descriptions and resumes regulatory submissions correspondence with regulatory agencies and regulatory tracking databases. Collaborate with regulatory affairs teams to ensure alignment of training programs with current regulatory expectati

Provide ongoing regulatory support to the regulatory affairs team lead and project teams to ensure regulatory concerns are addressed and relevant data is generated to meet project objectives. Document and track regulatory submissions and regulatory authority license approvals for the EU market, part

As Director, Litigation, Competition & Regulatory Affairs, EMEA, you will be the primary litigation, competition and regulatory counsel for the Sony Interactive Entertainment (SIE) business in the EMEA region, including Europe and the UK. You will handle a wide range of litigation matters, working c

A growing medical device organisation near Watford is seeking a Regulatory Affairs Manager for Class I wound-care devices. Ideal candidates have over 5 years in regulatory affairs with expertise in UKCE marking and ISO 13485. The role entails leading regulatory compliance efforts, managing Technical

Strong communication and coordination skills in order to achieve a consistent approach to engaging with the regulators in the UK and as necessary across the EMEA Division including the preparation and/or review of regulatory communications, briefing of senior management, including Board and Manageme

We are seeking an experienced Senior Regulatory Manager with strong expertise in EMA regulatory affairs to join their dynamic team. Strong regulatory affairs experience with a focus on EMA submissions. This role offers the opportunity to lead regulatory strategy, manage submissions, and act as a key