Regulatory Affairs Job Description in the Bay Area

The San Francisco Bay Area is a hub for biotechnology and pharmaceutical innovation. Consequently, the demand for skilled Regulatory Affairs professionals is high. This article outlines the key responsibilities, qualifications, and the overall impact of a Regulatory Affairs role within a leading pharmaceutical company like AbbVie in this dynamic region.

Company Overview: AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. They strive to have a remarkable impact on people's lives across several key therapeutic areas, including immunology, oncology, neuroscience, and eye care, as well as products and services in their Allergan Aesthetics portfolio. For more information about AbbVie, please visit www.abbvie.com.

The Role: Regulatory Affairs Manager

This role is based in the San Francisco Bay Area, focusing on supporting multiple Global Regulatory projects and contributing to the advancement of leading-edge cancer research within a biotech-like environment inside a large pharmaceutical company.

Key Responsibilities

• Support multiple Global Regulatory project teams and key sub-teams; provide functional expertise to GRLs and matrix early development teams.
• Collaborate with AbbVie regional and country regulatory affiliates to support ex-US clinical development activities.
• Provide support to prepare for presentations of Regulatory strategies and issues at team or governance meetings.
• Serve as primary Health Authority contact for assigned projects and foster positive and effective working relationships between project team members and regulatory authority reviewers.
• Assist in preparing teams and materials for FDA (or other regulatory authority) meetings.
• Participate in or lead the creation, review, assembly and submission of regulatory documentation including clinical trial applications and amendments to these regulatory files, as appropriate.
• Ensure consistency/completeness/adherence to standards for all regulatory submissions.
• Coordinate and consult with other departments on the content, review of publication materials, and assembly of regulatory documentation.
• Support or lead non-program specific projects as assigned such as department initiatives, business development assessments, clinical assessments, and department training, etc.

Core Functions

The Regulatory Affairs Manager plays a crucial role in ensuring that pharmaceutical products meet the necessary regulatory requirements for approval and market access. This involves:

• Organizing regulatory submissions to health authorities (HAs).
• Identifying & gathering data to support filings, responses to inquiries, & registration maintenance to enable commercialization of products that are developed, manufactured or distributed to meet relevant regulatory HA requirements.
• Interpreting FDA/EMA regulations, guidelines, policy statements, etc. for drug therapeutics.
• Presenting pertinent regulatory information to appropriate cross-functional areas.
• Operating in compliance with regulations, company policies, procedures, & guidance in alignment with regulatory product strategy & Quality Dossier Program (QDP).

Qualifications and Experience

To be successful in this role, candidates typically possess the following qualifications:

• Bachelor’s degree or equivalent required in related discipline.
• 5 + years of experience in biotechnology or pharmaceutical industry, including R&D/related disciplines.
• 3-4 + years of experience in Regulatory Affairs within biotechnology/pharmaceutical industry.
• Demonstrated understanding of regulations and guidelines governing drug development; has relevant knowledge and experience in applying these to strategic drug development
• Effective interfacing with regulators; has experience working with Health Authorities.
• Strong written and verbal communication skills.

A strong educational background is essential:

• A Bachelor’s degree or foreign academic equivalent in Pharmacy, Biology, Chemistry, Pharmacology or an industry-related field of study with at least 6 years of regulatory, R&D, or industry-related experience.
• Alternatively, a Master’s degree or foreign academic equivalent in the aforementioned fields of study with 2 years of related regulatory, R&D, or industry-related experience.

Key Skills

• Perceived as a subject matter expert by internal colleagues.
• Works effectively in complex, matrix organizations; drives outcomes and recommendations for action/consideration.
• Demonstrate expertise and knowledge of oncology and relevant indications.
• Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance.
• Learns fast, grasps the 'essence' and can change the course quickly where possible.
• Raises the bar and is never satisfied with the status-quo.
• Creates a learning environment, open to suggestions and experimentation for improvement.
• Embraces the ideas of others, fosters innovation, and recommends new ideas.

Additional Information

Companies like AbbVie support their colleagues around the world as they care for themselves and their families with offerings tailored to their unique needs. They strive to provide environments where all employees feel welcome and able to bring their full selves to work. To do this they integrate diversity, equity, and inclusion. At Abbott, sustainability means managing efforts so they can help the greatest number of people around the world live fuller lives through better health. They also provide reasonable workplace accommodations.

Compensation: The compensation range is based on the job grade for the position. Individual compensation paid within this range will depend on many factors including geographic location.

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