Post for General Manager - Regulatory Affairs @ Promed

They at Promed firmly believe that business organizations must contribute towards the wellbeing of society. To them, CSR is not charity but is sustainable development and empowerment of the community. The Promed team volunteers for several innovative programmes in the areas of public health, education and environment. They also undertake 'Joy of Giving Week' along with the non-governmental organization - Goonj wherein all employees donate old clothes, utensils, books, blankets etc.

Post: General Manager - Regulatory Affairs

Job Description:
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.

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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.
Candidiate should be M.Pharma from reputed institute with excellent communication and knowledge of filling in Regulated market like EU, TGA, Canada and USFDA in eCTD

Additional Information:
Experience: 12-15 Years
Location: Gurgaon
Education: B.Pharm, M.Pharm, M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA
End Date: 3^rd Nov., 2011