Senior Associate, Regulatory Affairs

The Opportunity:

• Represent Regulatory Affairs on project teams and closely collaborate with multidisciplinary teams to identify submission requirements, coordinate the content and development process (planning, creation, review, and approval) of selected regulatory documentation for inclusion in submissions to global health authorities.

• Coordinate the content development process (planning, creation, review, and approval) of selected regulatory documentation for inclusion in submissions to global health authorities.

• Compile regulatory submissions that meet ICH or FDA requirements, other local or regional regulatory requirements, as applicable, and company policies and procedures.

• Prepare and manage routine submissions and related activities.

• Assist in the development and implementation of SOPs and systems to track and manage product-associated events.

• Investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context to assist in assessment of regulatory implications for development and approval.

• Assist in the development of regulatory strategy and update strategy based upon regulatory changes.

• Stay abreast of changes in the regulatory environment and guidelines (e.g., FDA, ICH) in areas relevant to company projects.

• Work with manager on acquisition and development of required regulatory skills and knowledge.

• Function as the Subject Matter Expert (SME) of Clinical Trial Regulations (CTR) in the EU.

• Function as the Subject Matter Expert on the internal cross functional process for collecting and submitting investigator documents to INDs.

• This includes developing and providing training within teams.

Required Skills, Experience and Education:

• Bachelor’s degree or equivalent in Biology, Pharmacy, Chemistry or related. 

• Two (2) years of experience in Regulatory Affairs.

• Internship or work experience to include:

• Working with regulatory requirements for development of drug and biological products including FDA (Food and Drug Administration) regulations and guidance and ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) guidelines;

• Compiling, managing and submitting submissions to global health authorities;

• Working in an electronic Regulatory document information management system;

• Conducting regulatory research in assigned markets to understand product classification requirements, regulatory frameworks, and submission pathways;

• Maintaining regulatory documentation archives, registration databases, and tracking systems to support submission history and facilitate regulatory inspections;

• Assisting in investigating regulatory issues related to product and process compliance, troubleshooting, and providing solutions to support product approvals and ongoing compliance;

• Working with cross-functional teams to address regulatory challenges and ensure regulatory requirements are met at each development stage.

• Successful completion of background and employment history verification required.

• This position allows for a hybrid work arrangement. The employee must reside in the San Francisco Bay area and may work remotely two (2) days per week.