Senior Global Regulatory Scientist

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

📋 Description

• Ensure that regulatory deliverables are in alignment with applicable regulations, guidelines, policies, and procedures within specified timelines and budget constraints.

• Collaborate with stakeholders to formulate comprehensive global clinical trial submission strategies, including the identification and mitigation of risks.

• Lead regulatory project teams assigned to clinical trials.

• Act as the primary point of contact for clients concerning clinical trial regulatory deliverables.

• Develop regulatory plans for clinical trials in accordance with project requirements.

• Prepare, create, modify, coordinate, compile, and ensure compliance of global core documents.

• Monitor and report on the progress of submissions and approvals in CTMS, eTMF, and other relevant systems.

• Conduct quality control reviews of regulatory deliverables related to clinical trials.

• Oversee submissions to regulatory agencies, central ethics committees, and national authorities.

• Manage the review and approval process for clinical trial labels.

• Administer regulatory study budgets and identify activities that fall outside of the scope.

• Assist in maintaining up-to-date Country and Regulatory Intelligence.

• Provide regulatory consulting services as required.

• Engage in business or organizational development initiatives.

• Mentor junior team members as necessary.

⛳️ Requirements

• Bachelor’s degree in a scientific discipline.

• 3-6 years of pertinent global regulatory experience in clinical trials for pharmaceuticals.

• Strong communication skills and experience in client-facing roles.

• An adaptable personality with a flexible mindset.

• Proficiency in English.

• Legal authorization to work in the country where the position is located.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellbeing programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellbeing resources.

• Opportunities for learning and development through structured training and career pathways.