Exciting Opportunity in Regulatory Affairs - Sr. Director
Location: Redwood City, CA (Onsite 3 days per week)
Company Overview:
A pioneering biotechnology company, at the forefront of cortisol modulation research and development, is seeking a dynamic Regulatory Affairs Sr. Director to join their innovative team. With a robust pipeline of over 1,000 selective proprietary cortisol modulators and a history of groundbreaking FDA approvals, this company is dedicated to advancing the possibilities of cortisol modulation to treat serious diseases across various therapeutic areas
Role Overview:
As a Regulatory Affairs Sr. Director focused on oncology products, you will lead regulatory strategy, filings, and health authority interactions, providing strategic and operational leadership to support the development of innovative drug products. This role requires a strong understanding of global regulations and extensive experience in regulatory affairs within the biotechnology or pharmaceutical industries.
Responsibilities:
Develop global regulatory plans to support programs in all phases of development, identifying risk mitigation strategies and influencing project teams to maximize regulatory success.
Support efficient conduct of development programs while ensuring compliance with global regulatory requirements and company procedures.
Manage regulatory documents/submissions for IND/CTA and marketing applications.
Prepare for and attend meetings and teleconferences with regulatory agencies.
Monitor changes in global regulations governing drug development and contribute to process improvements.
Preferred Skills and Qualifications:
10+ years of experience in Regulatory Affairs in biotechnology or pharmaceutical industries.
Extensive drug development experience with a focus on regulatory strategies.
Experience preparing global regulatory submissions including INDs, CTAs, and marketing applications.
Familiarity with Electronic Common Technical Document format and regulatory inspection readiness.
Ability to travel to agency meetings (US and international).
Senior management experience with the ability to develop and lead a team.
Excellent verbal and written communication skills.
Preferred Education:
PhD in a scientific discipline, Medical Degree, or PharmD.