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Scientific Search · 1 day ago

Senior Director Regulatory Affairs

South San Francisco, CA

Full-time

Hybrid

Director/Executive

$270K/yr - $285K/yr

15+ years exp

Scientific Search has partnered with a commercial stage pharmaceutical company seeking a Senior Director, Global Regulatory Lead. This role is accountable for developing global regulatory strategies for assigned products and serves as the primary regulatory interface within the organization for assigned projects/products.

Human ResourcesStaffing Agency

Growth Opportunities

Responsibilities

Develops and oversees the global regulatory strategy for projects in assigned TA, in conjunction with and under the leadership of the SVP, Global Regulatory Affairs

Leads the Global Regulatory Project Team meetings in collaboration with Regulatory Project Management when being the Global Regulatory Lead on a project

Oversee the preparation of regulatory documentation (meeting request/briefing books) in support of interactions with a Health Authority and provide guidance to their team

Overseas/leads the preparation and the critical review of submission documents to ensure compliance with regulatory requirements

Contributes to and reviews responses to global Health Authority questions to ensure appropriate, consistent, and complete responses, ensuring their alignment with global development strategy

Provide global regulatory advice through the product life cycle by representing the regulatory function in the Program Team when being the Global Regulatory Lead on a project

In partnership with Regulatory Project Management, Regulatory Labelling and Regulatory CMC, oversees the development of content and format for regulatory submissions and related variations/amendments internationally in assigned TA

Actively participates in Health Authority meetings

Clearly articulate regulatory challenges/risks, identify potential solutions, and make a recommendation(s) on a path forward to Program Teams and Senior Management

Responsible for maintaining a working knowledge of regulatory requirements and guidelines and for communicating regulatory changes to Program Teams

Effectively manages direct report(s) and provide mentorship to junior professionals

Qualification

Global Regulatory AffairsRegulatory Strategy DevelopmentRegulatory SubmissionsPharmaceutical Industry ExperienceHealth Authority InteractionMentorshipTeam LeadershipCommunication Skills

Required

Bachelor's or Master's degree in biological or life sciences or related scientific discipline, pharmacy or medicine (or international equivalent); an advanced degree is desirable

A minimum of 15 years in the pharmaceutical industry with a minimum of 12 years in Global Regulatory Affairs, experience with major Health Authorities (US FDA, Health Canada, and EMA) is mandatory

Strong understanding of US FDA, EU and international pharmaceutical guidance, regulations, drug development process, and industry standard practices

Preferred

Experience with major regulatory submissions (e.g. New Drug Applications (NDA/NDS/MAA), Pediatric Investigation Plans (PIP) and Orphan Drug Designation (ODD) activities) is highly preferred

Experience in all phases of development and post marketing activities is highly preferred