Regulatory affairs jobs in Irvine, California - Page 2Create job alerts

The Senior Administrative Assistant will support the Global Regulatory Affairs Strategy organization. Senior Administrative Assistant - Regulatory Affairs (Office-based).

Advanced degree (PhD, PharmD, MD, MS) or BS in a scientific discipline with 10+ years of regulatory affairs experience in the biotech/pharmaceutical industry, including 5+ years at the Director level or above. The Senior Director, Regulatory Affairs will:. Serve as the regulatory lead on cross-funct

They are seeking a Senior Vice President of Regulatory Affairs to oversee all regulatory activities and be their primary strategic advisor on global regulatory strategy. Build, lead, and manage the Regulatory Affairs function to ensure adherence to regulatory standards and requirements for the compa

The role will report directly to the Director of Regulatory Affairs and contribute to advancing development programs through key regulatory milestones. As part of this growth, the organization is seeking a Regulatory Affairs Manager CMC to join their Regulatory team in San Francisco. Regulatory Affa

With strong early momentum and a clear path toward clinical and regulatory milestones, the team is looking to bring on a Vice President of Regulatory Affairs & Quality to build and lead the entire RA/QA function from the ground up. Regulatory Affairs / Quality within medical devices. Vice President,

They are seeking a Regulatory Affairs Director who can lead the development and implementation of Regulatory strategy for a key oncology asset. Represent Regulatory Affairs in cross-functional teams and governance forums, providing regulatory expertise throughout the product lifecycle. US/EU Regulat

Seeking an Associate Director, Regulatory Affairs leader to drive global regulatory submissions (IND/CTA) and shape the development of a cutting-edge small molecule portfolio. Senior Director, Regulatory Affairs. With nearly half a billion in total funding, this Rare disease biotech brings a unique

We're looking for a Head of Regulatory Affairs (VP/SVP) who can build the regulatory organization from scratch, set strategy, and operate with urgency and clarity. Build and scale the regulatory function, including hiring, vendor oversight, and establishing systems, processes, and infrastructure. Pa

Reporting to the Senior Director of Regulatory Affairs, you will lead the preparation of regulatory submissions, support interactions with Health Authorities, and help ensure the effective implementation of regulatory strategies. Serve as the Regulatory Affairs lead for assigned programs, providing

Associate II, Regulatory Affairs Strategy supporting the Global Regulatory Team in Lake Forest, Irvine, CA, Fort Worth, Houston, TX, or Sinking Springs, PA, a typical day will include:. Perform specialized tasks and conduct independent research within the Regulatory Affairs Strategy team to optimize

Ensure contracts meet applicable regulatory requirements and incorporate effective strategies for payer-specific policies and operational requirements. Stay informed on industry trends, regulatory changes, market developments, and payer-specific policies that may affect contract performance, and com

Compliance Specialist (Regulatory Affairs). Assist with drafting new policies and updating existing policies as required to ensure regulatory compliance, identifying areas of risk and recommending improvements. Monitor oversight and assist in ensuring compliance to regulatory standards and health pl

Represent Regulatory Affairs on cross-functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for non-medical devices, and medical devices. Assess the acceptability of documentation for medical device submissions and effec

Represent Regulatory Affairs on heart valve repair product development and manufacturing teams, providing regulatory input across the full product lifecycle, including design, verification/validation, clinical evaluation, and post-market activities. From design to production, our Regulatory Affairs

Europe, support of international product registrations and related regulatory affairs activities, including execution of procedures and systems designed to ensure that the product development process addresses all regulatory requirements as well. Regulatory Submission Specialist. This position is re

From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international regulatory environments. Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including p

The Regulatory Affairs Specialist (FDA, DEA) will ensure BaRupOn's pharmacy, manufacturing, and healthcare operations meet all applicable regulatory requirements. Associate degree in Life Sciences, Regulatory Affairs, or related field (Bachelor's preferred). Regulatory Affairs Certification (RAC) or

Immediate need for a talented Coord 3, Regulatory Affairs.

Demonstrated knowledge of Regulatory Affairs regulations, guidance, and procedures (Good Mfg Practice, Good Practices training programs, SOP development, and GMP audits and inspections). Minimum five (5) years of experience in Regulatory Affairs. Prepare and submit product registrations and submissi

AmeriPharma is a rapidly growing healthcare company where you will have the opportunity to contribute to our joint success on a daily basis.We value new ideas, creativity, and productivity.We like people who are passionate about their roles and people who like to grow and change as the company evolv

Regulatory Affairs is responsible for planning, coordinating and implementing regulatory strategies for products that require government approval in SEA and Korea. Regulatory Affairs Specialist 3. Job Title: Regulatory Affairs Specialist 3.

Ensure compliance with applicable accounting standards and regulatory requirements (including GAAP, FASB, IRS, and higher education reporting standards) and support internal control reviews. Working knowledge of applicable accounting standards and regulatory requirements (e.

We’re looking for enthusiastic, self-driven, individuals to assist existing and prospective clients within our organization.This position will work with multiple clients throughout the day providing outstanding service and product knowledge.Distributes all benefit enrollment materials and

Metro One Security - 700 Newport Center Drive - Responsibilities: Monitor access control and challenge those without proper identification; Maintain the visitor management system and check visitors; Issue badges and access cards and maintain secure logs; Monitor a CCTV system; Handle incoming calls

Competitive pay / Medical, dental & vision / 401k / PTO - As a Customer Service Rep at Planet Home Lending, you will: Respond to borrower inbound calls concerning their account, ensuring high quality service and adhering to productivity and regulatory requirements; Research customer issues and work