Regulatory Affairs

Responsibilities of a Regulatory Affairs - Manager for HOD / Senior RA Executives :

Manages all the functions of the Regulatory Affairs Department including but not limited to * Scheduling activities of the department.

1. Dossier Preparation and Review

• Oversee the preparation of technical product dossiers, ensuring accuracy, completeness, and compliance with regulatory requirements.
• Review dossiers prepared by team members to ensure they meet national and international standards.
• Provide guidance and technical expertise to the team during dossier preparation.

2. Regulatory Submissions and Approvals

• Manage applications for licenses, permissions, and other regulatory approvals in the country of manufacture and export destinations.
• Coordinate with relevant regulatory authorities to resolve queries and ensure timely approvals.

3. Task Management and Timeliness

• Ensure timely completion of departmental tasks, adhering to internal and external deadlines.
• Prioritize assignments and allocate resources effectively to maintain productivity.

4. Compliance Assurance

• Ensure that all regulatory guidelines are strictly adhered to during product manufacturing and export processes.
• Stay updated on changes in regulatory requirements and communicate updates to the team.
• Coordinating the inspection of the organization facilities and contract facilities and developing procedures to ensure regulatory procedures to ensure regulatory compliance

5. Team Leadership and Development

• Supervise and mentor the regulatory affairs team, fostering a culture of collaboration and accountability.
• Conduct performance evaluations, provide feedback, and identify training needs for team members.

6. Documentation and Reporting

• Maintain accurate records of all regulatory submissions and approvals.
• Prepare regular progress reports for senior management, highlighting achievements, challenges, and solutions.

Skills needed

• Indian FDA guidelines knowledge
• Understanding & knowledge of standards of various international regulatory bodies SA/ZAZIBONA/EU.
• Organizational Skills- Work assignment, time management, working within strict time frames.
• Ability to solve regulatory queries & compliance matters.
• Knowledge of dossier types and filing requirements.

Responsibilities of a Regulatory Executives / Officers :

• To prepare and compile registration dossier as per the specific country guidelines and submit to regulatory authorities.
• To prepare, review compile re-registration documents.
• To prepare & review /check artwork, pack insert, SmPC etc.
• To study Regulatory guideline of assigned countries and to prepare checklist / template for registration dossier.
• To verify specification of excipients, active, finished product and packaging material and all required documents.
• Application, review, co-ordination, follow-up of legal documents COPP, FSC etc.
• Maintain Proper database w.r.t to master document dossier.
• To collect and verify all technical documents and information from various departments at the manufacturing site.
• Provide Regulatory support to various departments.
• Review follow-up and co-ordination for registration samples /WS and impurities required for analysis purpose.
• To reply any queries raised by respective regulatory authority, in timely manner.
• To maintain and update Registration certificate /information in regulatory data base.

Requirement :

• Prefer professionals with experience in Document (Process, Analytical) review, Dossier preparation and Submission- for ROW, EU and Other country.
• Regulatory Affairs Manager years experience of working in the regulated markets
• Regulatory Affairs Senior Executive / Officers - more than Two years experience in Pharma Regulatory Affairs will be preferred

Required Candidate profile for Manager Level :

• Strong oral/written communication, leadership & problem-solving skills.
• Ability to stay calm under pressure and make quick decisions.
• Proficient in relevant techniques, processes, PC & internet research.
• Well-organized with timely data/information management.