Senior Regulatory Affairs Executive

2 weeks ago

Ahmedabad, Gujarat, India Synerxia Healthcare Full time

Job description

SYNERXIA Healthcare Pvt Ltd is engaged into Manufacturing & Exports of Nutraceuticals-Health/Dietary Supplements along with Pharmaceutical Products, is one of the Upstart organization is looking for 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, Gulf Countries) 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/FDA\CDSCO 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

Interested candidates can share CVS at 

Role: Regulatory Affairs Compliance

Industry Type: Pharmaceutical, Life Sciences & Nutraceuticals

Department: Legal & Regulatory

Employment Type: Full Time, Permanent

Location: Ahmedabad

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