
Senior Regulatory Affairs Executive
3 weeks ago
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 santosh@synerxia.com
Role: Regulatory Affairs Compliance
Industry Type: Pharmaceutical, Life Sciences & Nutraceuticals
Department: Legal & Regulatory
Employment Type: Full Time, Permanent
Location: Ahmedabad
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