Deputy / Assistant Manager, Sr. Executive, Executive - Regulatory Affairs ( Formulation ) (closed)
I am T.G. Ramkumar from Associated Search Professionals Private Limited. I have 5.11 years of experience in End to End Recruitment, Handling Top, Senior and Middle Management Positions across India..
Salary Range :- ( Open to discuss for Potential Candidates, Its not a Major Problem )
Work Location :- Hyderabad ( Professionals from Anywhere in India can apply )
Hope you will feel interesting to apply yourself for this wonderful Opportunity. Kindly call me at 9840952212. Also, Share your Updated CV to :-> email@example.com
We are Searching Deputy / Assistant Manager & Sr. Executive & Executive- Regulatory Affairs ( Formulation ) for fast growing Pharmaceutical company in Hyderabad.
To prepare and/or review the Drug dossiers of solid orals and injectable formulations.
To Provide speedy support in preparation of dossiers and registration documents required documents required for ROW MARKET COUNTRIES ( SOUTH AFRICA, BRAZIL, ASEAN, CIS, LATAMS & NORTH AFRICA ).
To Co ordinate with Q.C, Production, R & D & BD department for preparation of Drug Dossiers of pharmaceutical formulaitons as per CTD requirements.
To Evaluate, compile and respond various Regulatory or customer queries.
To Evaluate on going changes and suggest actionable to comply with regulatory requirements and plan for variation filing for on going changes.
To review and suggest product developmental needs to comply with regulatory requirements.
To review specificatin for API and FP specifications and analytical method validations.
To evaluate and comment about requirements of clinical studies.
To evaluation on going requirements and guide respective stake holders to ensure compliance.
To ensure the compliance status of the quality systems followed at the manufacturing site inline with
the submitted dossiers.
To manage team of at least 10.
The ideal candidate should have experience of 3 - 10 years in Regulatory dossiers compilation / review, Deficiency Responses and Variation filing in ROW Markets countries ( South Africa, Brazil,ASEAN, CIS, Latams & North Africa ) in reputed pharmaceutical products manufacturing company.
The candidate should have knowledge of pharmaceutical development and Qhd aspects, analytical methods and validation, pharmacology, clinical studies, CTD requirement and well versed with current Regulatory Guidance.
Lead Consultant - Pharmaceutical