CEO at PULSE HR CONSULTANTS
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Regulatory Affairs - US Markets (1-4 yrs)
We have urgent opening in one of our reputed pharma client, based at Hyderabad location
- Regulatory CMC requirement for US market (Solid oral dosage form). Please share the profiles with 1.6 yrs to - 4 yrs experience.
- Research Associate IV - Regulatory affairs (Formulations) This position is for US regulatory team responsible for filing ANDAs/NDAs/Life cycle management/Supplements and Amendments etc.,
- Planning, reviewing and submission for assigned ANDA and NDA projects within timelines. Adherence to high quality, and regulatory standards in dossiers. Review and submission of Annual Reports (ANDAs/NDAs). Evaluation and good interpretation of post approval changes. Submission of supplements like CBE, CBE-30 and Prior Approval Supplement (PAS).
- Review and authorizing regulatory change controls.
- Knowledge of eCTD, Module 2 and 3. Preparing quarterly and monthly targets. Allotting and evaluating targets of the team. Good interpretation skill for ICH and FDA guideline. SOP identification, preparation, review and implementation.
- Formulate US regulatory filing strategy for new projects.
B. Pharmacy/M. Pharmacy, experience More than 1.5 to 4 Years in US regulatory affairs.
Computer knowledge/eCTD software knowledge
Total positions: 10 nos
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