Team Leader - Regulatory Affairs - Pharma

Regulatory Affairs- EU market

Designation: Team Leader- Regulatory Affairs.

Location: Mumbai.

- MA submission for EU market/EU regulatory

- B.Pharm/M.Pharm/MSc, 8-10 yrs experience in regulatory affairs with special focus on EU/UK filings for regulated markets.

- Experience in independently handling regulatory affairs particularly for Europe, UK is preferred.

KRAs:

- Responsible for preparation, submission and renewal of quality EU dossier (eCTD) in a timely manner.

- Responsible for preparation and review of Modules and quality summary modules.

- Responsible to prepare and review all technical documents and compliance with the regulatory requirement during the preparation, filing, and maintenance of all regulatory submissions including original submissions, variations and responses to deficiency letters.

- Responsible to remain updated with continuous development /changes in the regulatory environment globally.

- To maintain status of documents, records.

- To keep the track of relevant guidance.

- Responsible to assure effective proper communication with peers, seniors and subordinates across all locations.