Associate Director, Regulatory Affairs

This is a fully remote position, open to applicants in California.

📋 Description

• Assist in the formulation and implementation of clinical regulatory strategies for designated programs.

• Provide regulatory analyses, options, and recommendations.

• Organize, prepare, and oversee IND applications as well as other pre- or post-IND submissions.

• Manage regulatory timelines, deliverables, and commitments in collaboration with cross-functional teams.

• Prepare materials for health authority meetings, responses to information requests, and necessary supporting documentation.

• Engage in interactions with health authorities.

• Offer clinical regulatory guidance to cross-functional teams.

• Contribute regulatory insights into protocols, Investigator’s Brochures, and study reports.

• Implement regulatory activities in adherence to global and regional regulations, industry standards, and internal policies.

• Maintain documentation and practices that are inspection-ready.

• Identify regulatory risks, issues, and gaps while devising mitigation strategies.

• Lead clinical regulatory execution across cross-functional teams.

• Coordinate contributions from Clinical, Nonclinical, Biometrics, Medical Writing, CMC, and additional functions.

• Collaborate with CMC Regulatory Affairs and technical subject matter experts.

• Monitor regulatory developments and evaluate their potential impacts.

• Contribute to the refinement of regulatory processes, templates, and tools.

⛳️ Requirements

• Bachelor’s degree in life sciences with a minimum of 10 years of experience in the biopharmaceutical sector, including at least 8 years in regulatory affairs; or an equivalent combination of education, training, and experience.

• Proven experience in the preparation and management of INDs and related regulatory submissions.

• Experience in supporting interactions with health authorities and cross-functional development teams.

• Solid understanding of regulatory requirements and processes in major markets (U.S. and/or EU).

• Excellent written, verbal, and interpersonal communication abilities.

• Capability to operate efficiently in a dynamic, matrixed, and global environment.

• Upholds the highest standards of integrity and ethics.

🏝️ Benefits

• Sign-on bonus.

• Restricted stock units.

• Discretionary awards.

• Medical benefits.

• Financial benefits.

• 401(k) eligibility.

• Paid vacation.

• Paid sick time.

• Paid parental leave.

• At-will employment.