Manager, Regulatory Affairs

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

📋 Description

• Evaluate study budgets and costs in relation to contract negotiations, engage in business development efforts, draft regulatory components of proposals and feasibility analyses, and attend bid defense meetings to fulfill business objectives.

• Oversee and manage submissions to regulatory and ethics committees, ensuring that approvals are maintained across EMEA, Asia Pacific, and Latin America regions, while accurately compiling, managing, and tracking all submissions.

• Offer expert regulatory guidance and support regulatory project initiatives. Communicate submission statuses effectively with the Sponsor, Project Manager, CRAs, and Medical & Scientific Affairs teams.

• Assist in the creation of technical documents such as IMPDs and IBs, reviewing and providing recommendations on all pertinent documentation to ensure adherence to ICH GCP and country-specific regulations.

• Deliver training, coaching, and mentorship to junior staff members, with the potential responsibility for line managing junior team members.

⛳️ Requirements

• A minimum of a four-year college degree with a major in medical, biological, physical, health, pharmacy, or another relevant science, OR: A two-year college degree or equivalent education/training (such as a nursing degree or similar life science qualification) combined with eight years of experience in clinical research (e.g., CRA, Regulatory Affairs).

• At least 5 years of experience in the pharmaceutical/CRO sector, demonstrating senior-level regulatory or clinical start-up expertise within the APAC region.

• Strong cross-cultural communication skills and proficiency in both spoken and written English.

🏝️ Benefits

• Health insurance

• Professional development opportunities

• Flexible working hours

• Remote work options