Associate Director, Regulatory Affairs
Location: Emeryville, CA
The Associate Director, Regulatory Affairs will be primarily responsible for managing regulatory activities that support department and company projects and programs. This position will assist with developing, coordinating and executing regulatory strategies for new product development registrations. The role will be responsible for troubleshooting discrepancies between products and regulatory requirements, and should anticipate and plan for changes in FDA and EU regulations and requirements
Major Areas of Responsibility
- Collaborate with Product Development, Clinical Operations, Manufacturing and Quality to develop, coordinate and execute the regulatory strategies for new product development registrations.
- Work with development teams to execute strategies for regulatory submissions. Generate regulatory submission plans, and direct document development, review, and finalization.
- Lead the preparation and submission of all sections of all filings to regulatory authorities, including, but not limited to, IND, NDA, CTA and MAA applications.
- Provide leadership in creating and executing proactive global regulatory strategies for product development, approval and registration, and support of future programs.
- Lead global regulatory submission preparations per plan with minimal to no supervision. Responsible for obtaining approval including negotiation with the regulators in US and ROW with minimum to no supervision.
- Proactively build relationships and trust with key internal and external stakeholders and decision makers.
- Manage relationship with external consultants/CROs supporting development of study start up
- Develop and implement regulatory strategies, including regulatory risk management, ensuring that any RA issues are highlighted and addressed satisfactorily and in a timely fashion.
- Participate as an active, engaged global team member on core projects and/or provide RA guidance/strategy to Core team members
- Manage/Mentor the Regulatory Affairs Manager in support of global regulatory development knowledge
- Other duties as assigned.
MINIMUM JOB QUALIFICATIONS
- PhD/PharmD with 5+ years experience in Regulatory Affairs or BS/MS with 10+ years experience.
- Has primary responsibility for coordinating the preparation of drafts, edits, review and submission of regulatory dossiers in support of investigational and new drug applications
- Works with project teams and department management to develop regulatory strategies, identify regulatory risks, and enable earliest possible approval
- Manages timelines for regulatory submissions
- Experience in working directly with the FDA. In-depth knowledge of FDA regulations, knowledge of CTD/eCTD, and all regulatory requirements for FDA submission requirements.
- Superior scientific writing skills for developing regulatory documents
PREFERRED JOB QUALIFICATIONS
- Executes department’s strategy in alignment with Manufacturing Operations, Quality, Clinical Operations, Compliance and company goals. Understands the regulatory environment for pharmaceutical companies, as well as pharmaceutical industry regulatory affairs best practices to satisfy regulatory requirements.
- Proactive, creative, forward-thinker with the ability to think innovatively
- Ability to engage regulators on new approaches and implement new strategies for product regulatory filings.
- Develops and maintains strong collaborative internal and external working relationships.
- International regulatory experience (e.g., EU and/or Canada)
SKILLS & ABILITIES REQUIRED
- Possesses a thorough knowledge of current FDA regulations and guidances of requirements for investigational products, IND and NDA submission requirements. Must support department in generating regulatory strategies to provide leadership to multidisciplinary teams.
- S/he should have a track record of successful interaction with the regulatory agencies, as demonstrated by timely submissions and approvals of pharmaceutical products.
- Possesses leadership skills and ability to interact with senior management, and to work with outside vendors and partner companies.
- Must be a demonstrated self-starter and team player with strong interpersonal skills. Must be a hands-on player.