General Manager/Senior General Manager - Regulatory Affairs - Pharmaceutical

We have an urgent job opportunity for GM/Sr GM Regulatory Affairs role based at Gurgaon.

Key Responsibilities :

- Providing regulatory strategy to R & D for NDA products being developed for US and other advanced markets like EU & Canada

- Ensure Timely filings of pIND, scientific meeting request, IND,Pre NDA, NDA.

- Ensure adequate and timely response to deficiencies securing timely approval as per agency timelines

- Manage the regulatory team responsible for US and Canada

- Ensure lifecycle management through timly submission of annual reports, supplements etc to ensure product continuity

- Collaborate with HoD in meeting department goals.

- Experience should not less than 18 yrs and have good understanding of Generic pharmaceutical Industry

- Hands of expertise of preparation & review of dossiers, response to quires, communication with agencies.

Position Summary :

- This role is responsible for delivering filing and approval target for NDAs for US, EU and other advanced markets.

- This position holder is required to work closly with R & D and other cross functional team leads in the organisation including BD, SGO, MSTG, Procurement and quality to ensure successful lifecycle management.

- This role will be responsible for managing the regulatory activities for US NDAs and Labeling. This role needs a seasoned professional who is aware of the regulatory activities for NDAs, can work in R & D CFT and who has the management capability of leading a group of FTEs.

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Anshita