SUMMARY OF THE JOB •

To review and submission of product dossiers to regulatory agencies, response to queries raised by regulatory agencies. • Provide regulatory Strategy for all new products and markets proposed by Business Development. • Provide regulatory support for launch of current products and maintenance of existing products in different markets.

KEY FUNCTIONS / RESPONSIBILITIES

- To communicate Countries specific regulatory requirements for each product / dosage form to developing departments such as PD, AD, Medical Affairs, Global Sourcing and Stability etc.
- To prepare guidelines notes / checklist in respect of registration / re-registration requirements of drugs in Global Regulatory Agencies like US-FDA, Health Canada, TGA, EMEA, MHRA, MCC etc.
- To review and submission of ANDA/Product Dossiers for Global Regulatory Agencies like US-FDA, Health Canada, TGA, EMEA, MHRA, MCC etc.
- To timely communicate the amendments made from time to time to all the departments.
- To update skills on e-CTD filing.
- To obtain marketing approvals of products throughout the globe and also to maintain regulatory compliance.
- Establishment registration and re-registration, Submitting Annual updates for approved dossiers. Submitting SUPAC oriented supplements to authorities.
- To provide training to all department of PRC on regulatory issues.



Closely co-ordinate with Medical section & foreign offices to obtain information about bio-equivalence studies & clinical studies of our products for inclusion into registration documents.
- To submit the complete & accurate registration / re-registration documents & samples well within time & to reply to all queries, as may be raised by registering authorities.

• Compliance of all India Laws, rules, regulations, notifications etc as may be applicable from time to time in respect of production, efficacy, trials, testing, clearing and such other regulatory requirements as may be applicable.

- Responsible for assuring maintenance of approval status for all marketed products.
- Keep management up-to-date on status of specific product registration action, problems & solutions.
- - Cooperates with the regulatory team and the cross-functional team to promote an environment of knowledge sharing and team effectiveness.

KEY RESULT AREAS
- To review and submission of ANDA/Product Dossiers for Global Regulatory Agencies like US-FDA, RU/CIS, Health Canada, TGA, EMEA, MHRA, MCC etc.
- Timely send the responses of queries raised by regulatory agencies

- To provide timely training on regulatory guidelines updation.
- To keep management up-to-date on status of specific product registration action, problems & solutions.
- To support plant during Regulatory audits by participating and providing requested documents and also reviewing of plant investigations for compliance.

- To support for conducting compliance audits at plant and SRC.

📌 DGM - Regulatory Affairs (Gurugram)
🏢 Sentiss Pharma
📍 Gurugram