Senior Regulatory Affairs Executive

position in Regulatory Affairs - Emerging / ROW Market for pre-submission and post-submission

Role and responsibilities

1.Responsible for preparing/reviewing various regulatory documents for Emerging markets (South East Asia, Africa, CIS, Latin America, GCC, Easter Europe) such as,

Dossiers in ACTD, CTD and in country specific format.

Variation filling, renewal fillings, Query response, Site registration applications, Tender fillings.

Legal Applications related to local FSSAI/FDACDSCO like FSC, COPP, Product permissions, WHO GMP inclusions.

Responsible for coordinating with functional teams for timely receipt of technical documents.

To verify and approve all technical documents in line with current regulatory requirements.

Regulatory Query Response and its impact.

Artwork development, amendments and maintenance without adversely affecting the business continuity to implement regulatory changes.

Maintain various regulatory status.

2. Monitoring of product lifecycle as per regulatory requirement.

3. Literature search, data collection, evaluation to meet the requirement of above job responsibilities.

Eligibility: Ideal Candidate should possess Degree in Pharmacy or equivalent with minimum 3-5 Years of Experience into Regulatory Domain

Candidate should have detailed knowledge on:

Regulatory requirements for submission of product dossiers.

Registration samples submission in ROW countries.

Candidate must have Good in written and verbal communications.

Candidate must have basic knowledge of Microsoft Word, Excel & Power Point

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Role:Regulatory Affairs Compliance

Industry Type:Nutraceuticals, Pharmaceuticals & Lifesciences

Department:Legal & Regulatory

Employment Type:Full Time

Location: Ahmedabad