Regulatory Manager

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

📋 Description

• Conduct research on existing product data in relation to global or regional regulatory standards.

• Develop gap analyses, product development strategies, and regulatory submissions.

• Prepare both administrative and technical elements for submissions related to INDs, pre-approval packages, product registrations, and post-approval maintenance.

• Create briefing materials for meetings with regulatory agencies or when seeking scientific advice.

• Contribute to and facilitate interactions with regulatory agencies.

• Oversee and implement daily regulatory activities while adhering to timelines, scope, budgets, and strategic plans.

• Offer regulatory assistance to multidisciplinary product development teams throughout the product lifecycle.

• Serve as a subject matter expert and resolve project-related challenges.

• Estimate costs for regulatory services within proposals.

• Assist in client meetings regarding proposals, project updates, and business development efforts.

• Ensure adherence to global regulatory requirements as well as company policies and procedures.

• Develop training resources and disseminate regulatory best practices both internally and externally.

• Engage in internal and external project audits.

• Support cross-functional initiatives within the organization.

• Establish and maintain SOPs and process documentation.

• Provide oversight to team members fulfilling project responsibilities.

• Recognize when additional support is necessary.

• Keep personal training records updated and complete all required training.

⛳️ Requirements

• At least 10+ years of experience in regulatory affairs.

• Proven experience in a leadership role managing a team.

• Competence in risk assessment, strategic planning, decision-making, and project leadership.

• Experience in managing relationships with both internal and external stakeholders.

• M. Pharm degree.

• Familiarity with CMC Module 3.

• Experience in authoring CMC sections for post-approval variations and lifecycle management activities.

• Knowledge of EU and GCC markets.

• Master's degree in a science-related field or equivalent experience in science/regulatory/medical writing.

• Moderate experience in the pharmaceutical or medical device sectors.

• Experience contributing to regulatory submissions such as IND, PMA, NDA, MAA, and CTD, including electronic formats.

• Exceptional written and verbal communication abilities.

• Strong customer service skills with the capacity to work independently and collaboratively within a team.

• Good quality management capabilities.

• Proficient in Microsoft Office applications.

• Ability to collaborate with staff across various departments and offices to establish project standards.

• Demonstrates initiative, adaptability, and proactivity.

• Strong analytical abilities and attention to detail.

• Capable of managing multiple projects concurrently with varying instructions.

• Fluent in spoken, written, and reading English.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and involved line management.

• Training in technical and therapeutic areas.

• Peer recognition initiatives.

• Comprehensive total rewards program.

• Inclusive workplace culture.

• Reasonable accommodations when appropriate.