Regulatory Affairs Manager

Meyer Organics

5 - 10 years

9 - 17 Lacs

thane

Posted:4 hours ago| Platform:

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Skills Required

ctd dossier preparation product registration actd regulatory affairs

Work Mode

Work from Office

Job Type

Full Time

Job Description

Manage timely and professional delivery of regulatory activities for relevant products pro-actively to support the business goals including management of rationalization dossiers & related activities for Export products registration/renewal/variation for drug/ food/ other commodities items
Represent organization while responding to regulatory agencies queries and other correspondence after engaging and interacting with regulatory bodies of various countries
Preparing, submitting, reviewing regulatory file applications and supporting documentation with all registration related tasks post approval authorization, queries, post approval authorization-variations, renewals, fees (Pharmaceutical, Nutraceutical & Herbal)
Prepare dossiers as per requirement
Developing regulatory strategies for new products and vendors (third party manufacturing)
Advice and counsel to cross-functional teams including Packaging, QA, QC, R&D and production team.
Reviewing Artwork & PIL
Responding to agency deficiency requests within strict timelines
Contributing to the planning, execution, and assessment of product life cycle management activities and strategies
Contributing to developing CMO
New Product Development
Responsible for lifecycle maintenance of DMF (Drug Master File), SMF (Site Master File) and Method Validation.
Any other responsibility assigned by the technical head.

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