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West Coast Pharmaceuticals Works Limited

Sr. Executive - Regulatory Affairs

Ahmedabad
Gandhinagar
Full-Time
Mid-Level: 2 to 5 years
Posted on Jul 22 2024

About the Job

Skills

Knowledge of regulatory requirements
FDA
Attention to detail
Strong communication skills
Project management
Ability to work under pressure
Research skills

We are hiring for Sr. Executive - Regulatory Affairs. 

Qualification: B.pharm/M.pharm

Experience - 2 to 5 years only

Location - Sola, Ahmedabad

Work mode - on site


Role & responsibilities:- 

* Dossier preparation as per the ACTD & CTD (Module I, II, III, IV and V) guideline.

* Technical documents like Raw Material and finished products specification, manufacturing process,

* Product development report, stability reports, process validations preparation & review.

* Analytical method validation review as per the ICH guideline.

* Drug Master File review

* Technical query response to the various regulatory authorities.


Market – ROW: Africa, Latin America, Eastern Europe, the Middle East, and parts of Asia country exposure is required.


Thanks & Regards,

Yesha (HR)

Mo- 98751 70543

About the company

West Coast Pharmaceuticals Works Limited

We Ensure all product to meet our High Qwest-Coast Pharmaceuticals Works Limited is a global pharmaceutical company. It manufactures Pharmaceutical finished formulations, Dietary Supplements & Cosmeceutical Products. The company offers pharmaceuticals in a wide range of dosage forms, including capsules, tablets, ointments, liquids & creams. Plant is approved by WHO-GMP, NAFDAC-Nigeria, PPB Kenya & ...Show More

Industry

Pharmaceuticals

Company Size

501-1000 Employees

Headquarter

Ahmedabad, Gujarat

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