Regulatory Affairs Manager

𝗛𝗜𝗥𝗜𝗡𝗚 | 𝗥𝗘𝗚𝗨𝗟𝗔𝗧𝗢𝗥𝗬 𝗔𝗙𝗙𝗔𝗜𝗥𝗦 𝗠𝗔𝗡𝗔𝗚𝗘𝗥
📍 Location: Selaqui, Dehradun
💼 Experience: Minimum 7 years
👥 Team Handling: Minimum 2 years
🎓 Qualification: B.Pharm
💰 CTC: Up to ₹15 LPA
🗣️ Languages: English & Hindi – Mandatory
𝗝𝗢𝗕 𝗢𝗩𝗘𝗥𝗩𝗜𝗘𝗪
We are looking for an experienced Regulatory Affairs Manager with strong experience in Regulatory Affairs and Regulatory Operations to manage regulatory activities, ensure compliance, and support timely product registrations and submissions.
𝗞𝗘𝗬 𝗥𝗘𝗦𝗣𝗢𝗡𝗦𝗜𝗕𝗜𝗟𝗜𝗧𝗜𝗘𝗦
• Manage and coordinate regulatory submissions and related activities across assigned markets.
• Maintain regular communication with regulatory authorities and track ongoing submissions.
• Monitor regulatory updates and assess their impact on products and internal processes.
• Maintain proper documentation and records of regulatory requirements and guideline changes.
• Review and manage regulatory queries and ensure timely resolution.
• Coordinate with cross-functional teams to implement regulatory requirements.
• Manage product lifecycle and post-registration regulatory activities.
• Review and raise requests for regulatory dossiers and supporting documentation.
• Identify opportunities to improve regulatory processes and reduce time-to-market.
• Ensure ongoing regulatory compliance during manufacturing and distribution.
• Lead and support the regulatory team to ensure timely completion of activities.
𝗠𝗔𝗡𝗗𝗔𝗧𝗢𝗥𝗬 𝗥𝗘𝗤𝗨𝗜𝗥𝗘𝗠𝗘𝗡𝗧𝗦
✔ Minimum 7 years of relevant experience in Regulatory Affairs / Regulatory Operations
✔ Minimum 2 years of team-handling experience
✔ B.Pharm qualification is mandatory
✔ Strong experience in regulatory submissions, dossier management and post-registration activities
✔ Good understanding of regulatory guidelines and compliance requirements
✔ English and Hindi communication skills are mandatory
✔ Strong coordination and stakeholder-management skills
✔ Willingness to work from Selaqui, Dehradun
𝗖𝗧𝗖: Up to ₹15 LPA
📩 Interested candidates can share their updated CV : 📧 charan.mk@clinilaunchresearch.in

Work arrangement
No