Senior Director, Regulatory Affairs

Contineum Therapeutics • San Diego, CA

20h • Hybrid

About The Position

The Senior Director of Regulatory Affairs leads global regulatory activities and manages personnel for IND/CTA preparations, meetings, and maintenance to support new and ongoing development programs. This role reports to the Senior Vice President, Regulatory Affairs. This role can be hybrid out of the San Diego office or fully remote for a candidate based on the West Coast of the United States with some travel to the San Diego office.

Requirements

• Bachelor’s degree required; advanced degree preferred
• 12+ years of experience in pharmaceutical/biotech, with minimum of 10 years of experience in regulatory affairs including clinical regulatory affairs
• Experience managing and mentoring direct reports
• Experience with regulatory activities including creation of systems and processes to support efficient and high-quality submission of documents to regulatory bodies
• Ability to translate regulatory requirements into practical achievable plans
• Ability to build strong relationships with co-workers of various backgrounds and expertise
• Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment
• Strong organizational and multitasking skills
• Excellent communication and interpersonal skills

Responsibilities

• Represent regulatory on study and program teams throughout study conduct and product development
• Prepare and/or review regulatory documents required for global product development (e.g. New IND/CTAs, DSURs, IND Amendments, health authority meetings and briefing documents, iPSP/PIP, NDA/MAA)
• Provide oversight of regulatory submissions vendor to assure technical accuracy, compliance, completeness, and timely regulatory agency submissions
• Lead development of global regulatory submissions, including requests from regulatory authorities relating to clinical trials, and responses to health authority requests for information, as required
• Manage and mentor direct reports to achieve department and corporate goals
• Provide regulatory support for company compliance initiatives, including SOP development, and documentation initiatives, etc.
• Review relevant clinical documents (protocol, informed consent form, investigator’s brochure, and site documentation, and required regulatory forms) for regulatory compliance
• Keep current on US and OUS regulations that apply to company products and processes

Benefits

• 90% employer-covered benefits
• Flexible PTO
• A very generous holiday schedule that includes a week off in August and time off around the winter holidays
• A well-stocked kitchen with snacks and beverages
• Additional benefits include the opportunity for annual bonuses, stock options, an Employee Stock Purchase Program, and a 401(k) with an employer match
• The comprehensive wellness program includes medical, dental, vision, and LTD coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Senior