Associate Director Regulatory Affairs, Labeling

BioPhase specializes in recruiting top talented professionals for the San Diego County Scientific community. We are currently looking for a hybrid (3 days/week in-office) Associate Director of Regulatory Labeling to work for a leading San Diego biopharma company.

*Must be local to San Diego, CA in a hybrid capacity

Key Responsibilities:

Develop draft labeling text (such as USPI, PPI, Med Guide, EU SmPC, EUPIL) to support marketing applications and updates of approved package inserts for product lifecycle management.

Assist in implementing a labeling review and approval process, documenting label history, LMT/ELC decisions, and CCDS exceptions to facilitate a seamless global labeling process.

Ensure alignment of labeling strategy with overall regulatory and program strategy by collaborating with internal stakeholders including Regulatory Affairs, Clinical Research, Drug Safety, Quality, Commercial, Medical Affairs, Legal, Manufacturing, and Supply Chain.

Lead cross-functional labeling forums and meetings, such as LMT, to support draft label development.

Coordinate with Regulatory Strategy Lead to ensure timely submission and implementation of global labeling requirements consistent with the company’s CCDS position and in compliance with local regulations.

Effectively communicate regulatory labeling strategy, risks, mitigations, and overall plans.

Stay updated on labeling guidelines and regulations from FDA, EMA, and other relevant regulatory authorities worldwide.

Develop, implement, and maintain policies and procedures for labeling creation and management, and communicate these to relevant stakeholders.

Manage the review, quality control, and approval process for all product labeling components and CCDS.

Support the development of strategic plans for labeling negotiations, manage the internal review process, and participate in label-related Health Authority negotiation meetings.

Provide training and mentorship to other RA Labeling colleagues or cross-functional team members on various aspects of RA labeling.

Education/Experience Requirements:

Bachelor's degree in a scientific discipline or related field; preference for advanced degree such as PharmD.

Minimum of 8 years of progressively responsible experience in Regulatory Affairs, with at least 6 years specifically in global labeling. Demonstrated expertise in global regulatory labeling requirements and strategic planning for labeling.

Extensive experience in global prescription drug labeling, including familiarity with regulations in regions such as the U.S., EU, Australia, Canada, Japan, and/or Switzerland.

Proven leadership in guiding the development of labeling content through the regulatory submission and review process, including successful Health Authority negotiations leading to product approval.

Demonstrated expertise in devising and implementing intricate and creative global labeling strategies. Skilled in assessing and effectively communicating risk/benefit to senior management. Proficient in shaping organizational direction in labeling negotiations with regulatory authorities.

Comprehensive understanding of both US and international regulations relevant to pharmaceutical drug development.

What we offer:

As we work to develop innovations that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

· Full support and career-development resources to help you reach your potential

· A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act