Associate Director, Regulatory Affairs Strategy (Hybrid)

Position: Associate Director, Regulatory Affairs Strategy (Hybrid)
Company: Biotechnology Research
Location: South San Francisco, CA
Employment: Full Time
Benefits: Salary, Bonus, Equity, Healthcare Benefits

Job Description

Biotechnology Research company is seeking an accomplished, creative and dedicated regulatory professional to contribute to the company’s mission of helping patients with life-threatening fibrotic diseases. The position will report to the Head of Regulatory Affairs and will lead the regulatory strategy for company development programs. This includes strategic and operational leadership of global regulatory activities for molecules in the pre-clinical to clinical stage.

Responsibilities

• Independently develop regulatory strategies to meet business objectives for company’s development projects
• Lead the drafting and submission of regulatory dossiers as required to support global clinical trials, including initial INDs/IND amendments, IMPDs, annual reports, requests for information, etc.
• Lead Regulatory Authority interactions and the preparations for the interaction including briefing document content and preparation
• Lead the strategy, preparation and submission of regulatory applications such as e.g. ODDs, PIPs, Fast Track/BTD
• Participate on project teams and provide expertise on regulatory matters
• Establish, manage, and maintain knowledge of current and emerging regulatory requirements, guidelines, and best practices, and interpret and communicate relevant issues to the cross-functional team
• Assure compliance with regulatory standards and guidance documents
• Conduct regulatory risk assessments on issues that arise in development teams
• Lead or support the generation or revision of SOPs related to regulatory affairs
• Work with external regulatory consultants/CRO’s as required

Qualifications

• Bachelor’s degree in a scientific discipline required, advanced degree preferred
• Minimum of 7 years of related pharmaceutical or biopharmaceutical industry experience including at least 5 years in regulatory affairs
• Experience and knowledge in preparation of initial INDs/IMPD and amendments
• Experience in health authority interactions and addressing health authority questions
• Working knowledge of FDA, EMA and ICH regulatory guidance and regulations
• Small company / pre-commercial stage company experience desirable
• Strong collaboration and cross-functional team participation skills
• Ability to prioritize and manage multiple tasks while delivering on respective timelines for each
• Confidence in interacting with varying levels of internal management and external regulatory authorities
• Preference for applying a solutions-oriented mindset and approach to resolving complex regulatory issues
• High self-awareness and commitment to iterative learning and development
• Effective communicator, verbal and written, strong interpersonal and influencing skills