Senior Director Regulatory Affairs

Senior Director Regulatory Affairs at Scientific Search Senior Director Regulatory Affairs at Scientific Search in Millbrae, California Posted in 7 days ago.

Type:

full-time

Job Description:

Senior Director, Global Regulatory Lead Location :

South San Francisco, CA Base Salary :

$270-285k range plus bonus and RSU's Hybrid Onsite - Relocation Offered. Remote candidates will not be considered. Scientific Search has recently partnered with a commercial stage pharmaceutical company that is looking for a Senior Director, Global Regulatory Lead. This role is accountable for the development of global regulatory strategies for assigned products to meet business objectives. This position will be the primary regulatory interface within the organization for assigned projects/products and reports to SVP Global Regulatory Affairs. 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. Requirements 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. 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.

How To Apply:

We'd love to see your resume, but we don't need it to have a conversation. Send us an email to tom@scientificsearch.com and tell me why you're interested. Or, feel free to email your resume.