Sr. Executive / Assistant Manager - Regulatory
- Profile Hr Consultants
- 3 to 8 Yrs
- Mumbai
- 11 months ago
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Job Description
We have been retained by one of the Top 10 pharma Companies to hire a Senior Executive / Assistant Manager - Regulatory Affairs for Domestic Market. Details of the position are mentioned below:
- Company: Our Client is one of India's Top 10 Pharma Company with a sales turnover of more than 3,000 Crores. The company is a multi divisional company, each division promoting a specific range of products. HO of the company is located in the western suburbs of Mumbai.
- Designation: Senior Executive / Assistant Manager - Regulatory affairs for domestic market.
- Department: Scientific Services Department
- Job location: Mumbai (Western Suburbs)
- Educational Qualification: M. Pharm. Only M. Pharm candidates need apply for this position.
- Experience: 3 - 5 years of relevant experience in a reputed Pharma company. Even freshers who intends to make their career in the field of Regulatory Affairs can apply for this position.
- Roles and Responsibilities:
The role will involve expertise in D & C Act and Rules as well as FSSAI regulations with experience in FDA related activities. This profile will ensure timely and robust functional/cross-functional coordination (R&D, QC, Marketing, Legal, Production, etc.), transparent execution and implementation of regulatory affairs and safety processes.
Local Regulatory Function (Licensing):
- Prepare registration dossier for procuring certificates/license from local FDA, DCGI and FSSAI. This would entail thorough familiarity with FDA, Sugam & FSSAI online portal, Drugs & Cosmetics Act and its various Schedules e.g. Sch Y, M, etc.
- Confirm product formula and label acceptability, as well as the receipt of necessary licenses, prior to the release of product.
- Co-ordinate with QC and R&D departments for technical documents (manufacturing documents like batch records, specifications, analytical methods, validation reports, and stability data) required to be incorporated in the registration dossiers.
- Ensure timely renewal of drug and food licenses maintained by head office and also branch offices based at various states in the country.
- Online application for obtaining test license for import purpose.
- Maintain archival of all regulatory permissions.
- Keep abreast of the updates pertaining to regulatory requirements and accordingly implement them.
- Prepare responses to the legal & technical queries raised by the Regulatory authorities.
Compliance of Packaging Modules:
- Formulate and implement statutory requirements pertaining to the artworks of the products (label, carton, package insert, patient information leaflet, etc.).
- Review the artwork of all packaging material.
- Prepare package insert.
Pharmacovigilance
- Provide high quality medical writing from planning and coordination of literature research.
- Draft and review PSURs with focus on medical aspects of the products and safety sections.
- Review of Risk Management Plans as per Regulatory requirement.
- Good knowledge in assessing the risk-benefit of a product and identify any gaps in the aggregate documents.
- Perform scientific review of aggregate reports / ICSRs produced by PV Associates.
Those of you whose profile matches the above mentioned description and will like to apply for this position shall forward their updated profile to hidden_email
Employement Category:
Employement Type: Full timeIndustry: Recruitment Services
Role Category: General / Other Software
Functional Area: Not Applicable
Role/Responsibilies: Sr. Executive / Assistant Manager - Regulatory
Contact Details:
Company: Pharma Placements IncLocation(s): Mumbai
Keyskills: banking batch records mis sales tat accounts risk management plans
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