Manager, Regulatory Affairs

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

📋 Description

• Deliver specialized regulatory guidance and engage in regulatory project initiatives.

• Accurately compile, oversee, and monitor regulatory submissions.

• Draft regulatory components of proposals and feasibility reports, including regulatory costings and budgets.

• Participate in bid defense discussions.

• Enhance departmental workflows and contribute to company initiatives.

• Strategically plan, organize, compile progress, and submit regulatory submissions alongside the Regulatory Affairs Director.

• Coordinate and oversee submissions to regulatory and ethics committees, ensuring approvals are maintained across EMEA, Asia Pacific, and Latin America.

• Keep abreast of evolving regulatory legislative requirements and update the regulatory intelligence database accordingly.

• Contribute to the creation of technical documents such as Investigational Medicinal Product Dossiers (IMPDs) and Investigator Brochures (IBs).

• Review labels, patient information sheets, diary cards, and other documentation to ensure compliance.

• Communicate the status of submissions to Sponsors, Project Managers, Clinical Research Associates (CRAs), and Medical and Scientific Affairs personnel.

• Adhere to Standard Operating Procedures (SOPs), ICH Good Clinical Practice (GCP), and national regulatory standards.

• Cultivate professional relationships with both internal and external stakeholders.

• Provide training, coaching, and mentoring to junior staff, and potentially manage them directly.

• Act as a deputy for the Regulatory Affairs Director.

• Undertake additional assigned responsibilities.

⛳️ Requirements

• Bachelor’s Degree in Chemistry, Life Sciences, Nursing, or an equivalent qualification.

• Prior experience in the pharmaceutical or Contract Research Organization (CRO) sector.

• Demonstrated leadership capabilities and organizational management expertise.

• Strong skills in planning, strategizing, managing, monitoring, scheduling, and evaluating.

• Exceptional written and verbal communication abilities.

• Robust interpersonal skills in a dynamic, deadline-driven, and evolving environment.

• Capacity to manage multiple tasks in a fast-paced and ever-changing setting.

• Ability to exercise sound judgment and make independent decisions.

• Outstanding self-motivation capabilities.

• Proficient in Microsoft Word, Excel, and PowerPoint.

• In-depth knowledge of ICH Good Clinical Practice (GCP).

• Comprehensive understanding of the EU Clinical Trials Directive and national regulations, including Clinical Trial Applications (CTAs), amendments, urgent safety measures, and end-of-trial notifications.

• Extensive knowledge of drug development processes.

🏝️ Benefits

• A diverse and inclusive workplace.

• Accessible leadership and cohesive, supportive teams.

• Opportunities for training, coaching, and mentoring.

• Commitment to equal employment opportunities.

• Exceptional employee experiences.

• Chance to collaborate with a global team.