(Senior) Director, International Regulatory Affairs – Permanent – San Francisco Bay Area

Proclinical is seeking a (Senior) Director, International Regulatory Affairs for a growing biopharmaceutical company located in the San Francisco Bay Area, California.

Primary Responsibilities:

In this role, you will be responsible for providing strategic regulatory guidance to ensure compliance with all applicable regulations and guidelines for marketing authorization submissions outside the US. This role will collaborate closely with cross-functional teams to support product launches, lifecycle management, and other development and commercial activities.

The position is based in the San Francisco Bay Area (California) in a hybrid work schedule (preferred) or remote based (must be West Coast US based).

Skills & Requirements:

• A degree in a life science or closely related discipline with a higher degree preferred (e.g., MSc, MPH, PhD, PharmD.).
• A minimum of 15 years direct pharmaceutical regulatory affairs, including 5 years of International Regulatory experience is required.
• Experience in a small company and hands-on marketing application experience from preparation through submission and approval in a non-oncology, rare disease indication is strongly preferred in regions including, but not limited to EU, APAC, and LATAM.

The (Senior) Director, International Regulatory Affairs will:

• Contributes to the development of regulatory plans and strategies, identifies and proposes risk mitigation strategies, and influences project teams and sub teams across international site locations.
• Assist in developing and implementing strategies for the earliest possible approvals/clearance of regulatory submissions associated with assigned projects consistent with corporate goals and strategies.
• In close collaboration with local partners and/or CROs, proactively lead the preparation, submission, and maintenance of global regulatory dossiers while ensuring consistency of content and messaging across applications.
• Provide regulatory advice and information to cross-functional teams and to other functional areas (i.e., CMC, nonclinical, and clinical) for product development and planning to support the timely achievement of company and department goals.
• Prepares and/or manages submissions that may be technically complex and require extensive interaction with departments outside of regulatory affairs.
• Leads the drafting, review, and finalization of responses to queries from Regulatory Authorities

If you are having difficulty in applying or if you have any questions, please contact Phu Huynh at (+1) 646-779-7961 or .

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.