Finecure Pharmaceuticals Ltd Vacancies Careers 2023 | Ahmedabad Regulatory Affairs Jobs

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About Finecure Pharmaceuticals Ltd:

Finecure Pharmaceuticals Limited is a leading manufacturer and marketer of pharmaceutical formulations and Nutraceuticals in several therapeutic segments in dosage forms of Tablets, Capsules, Oral Liquids, Dry Syrup, Powders, Injections, sachets and Effervescent.

The company is WHO GMP certified and also certified for ISO 9001: 2008, ISO 22000: 2005, ISO 14001: 2004, and OHSAS 18001: 2007 quality systems towards High Product Quality Assurance, Environment Management systems, Occupational Health and safety.

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About Finecure Pharmaceuticals Ltd Jobs Vacancy:

Job Opportunity: Sr. Executive to Assistant Manager – Regulatory Affairs Department at Finecure Pharmaceuticals Limited

Finecure Pharmaceuticals Limited is currently seeking a dynamic and talented individual to join our Regulatory Affairs team as a Sr. Executive to Assistant Manager at our Ahmedabad location.

Responsibilities:

As a part of our RA team, you will be responsible for a wide range tasks, including but not limited to:

  • Dossier Compilation: Prepare, review, and compile regulatory dossiers in accordance with local regulatory guidelines, focusing on the Common Technical Document (CTD) format.
  • Must be aware of the latest country specific guidelines for ROW market and capable of planning and implementing, guiding, supporting, reviewing and finally approving the dossiers and implementing the other defined activities of the department.
  • CTD Formatting: Utilize comprehensive knowledge of CTD structure and requirements to format and organize documentation for submission, ensuring consistency and adherence to guidelines.
  • Regulatory Compliance: Stay up-to-date with the latest regulatory guidelines, requirements, and updates related to dossier submissions in India. Ensure that all submissions comply with the relevant regulations and guidelines.
  • Document Management: Maintain a well-organized document management system for regulatory documentation, ensuring easy retrieval and reference for future submissions and audits.
  • Collaboration: Collaborate closely with cross-functional teams, including Regulatory Affairs, Quality Assurance, Research and Development, and Clinical teams, to gather and incorporate necessary information for dossier preparation.
  • Quality Control: Conduct thorough quality checks on all submitted documents to identify and rectify any discrepancies, inconsistencies, or errors before submission.
  • Submission Coordination: Coordinate and assist in the preparation of submission packages, including cover letters, application forms, and any additional documentation required by regulatory agencies.
  • Timeline Management: Ensure that all dossier submissions are completed within the stipulated timelines, meeting both internal and regulatory agency deadlines.
  • Audit Readiness: Maintain accurate and updated records of all regulatory submissions, correspondence, and documents to facilitate internal and external audits.
  • Drug master File review.

Qualification: B.Pharma/M.Pharma

Minimum Experience: 4 Years – 7 Years

How to Apply: Please share your CV at krupali@finecurepharma.com.

Finecure Pharmaceuticals Limited offers a stimulating work environment, opportunities for professional growth, and competitive remuneration.

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FAQ Related To Finecure Pharmaceuticals Ltd

Q. Who is the owner of Finecure Pharmaceuticals Ltd?

Ans: Clav Richards – Owner – Finecure Pharmaceuticals Ltd.

Q. What is the address of Finecure Pharmaceuticals Ltd’s manufacturing unit in Uttarakhand?

Ans: 2C78+VG2, plot no.42, IIE, Pantnagar, Sector 4, Rudrapur, Uttarakhand 263153.

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