A Leading Pharma Group with Global Presence and approvals from EU-GMP, MHRA-UK, ANVISA Brazil, PICS Ukraine, WHO Geneva, INVIMA Colombia, USFDA*
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We have 3 facilities in North India and 1 R&D center at Bengaluru,
1. Immacule Lifesciences- Manufacturing of Liquid and Lyophilized injections approved from MHRA, ANVISA, PICS Ukraine, USFDA
2. Acme Formulation Pvt Ltd- Comprises of 2 blocks (General & Hormone), manufacturing Tablets, Capsules approved by WHO Geneva
3. Acme Generics LLP – Comprises of 2 blocks (General & Thyroxine), manufacturing Tablets, Capsules approved by EU-GMP
Position: Manager – Regulatory Affairs – Sterile Injectables
Location: Baddi, Himachal Pradesh
Job Description:
Required Candidate from Regulated Market and Pharmaceutical Background only (US/UK/EUROPE etc)
- Manage and lead the Regulatory Affairs Department in handling different regulatory authority requirements.
- Responsible for preparation, review, and approval of complete dossiers as CTD or eCTD to Regulatory Authorities.
- Authorized to handle Inquiries from Regulatory Authorities related to the company and product registration.
- Submission of Registration Dossiers in ROW, Semi-Regulatory and the Emerging market as of now.
- To ensure timelines are met for the project submissions including dossier, query response, variations, reports, renewal procedures, and all other regulatory applications
- Involved in Design and approval of product Artwork, SPC, and PIL.
- To impart training to various functions in-line with the current regulatory requirements of various countries at regular intervals to make the team effective.
- Coordinating and preparing for Regulatory and QP Audits, Quality Management System set-up, Communication & information / Data Management Skills, Team/Project Leadership & Management
- Assisting QA/QC and R&D departments for the preparation documents as per international requirements.
- Strategy planning for the Regulatory filings Regulatory personal recruitments and training Work distribution and review Strategy and planning for the regulatory dossier filing.
- Reviewing all technical documents like DMFs, Stability data and protocol, COAs, process validation, analytical method validation, and media fill validation, HVAC validation, SOP, STP/Spec. as per the requirement of the dossier preparation and registration
- Ensuring the transfer and implementation of all the approved documents to Plant, QA, QC, and customers.
Qualification: Appropriately Qualified
Experience: 10-18 Years
Salary: 12,00,000 to 22,50,000 INR CTC/PA
Contact Details:
01795-248312
hr@acmegenerics.in, rahul.verma@acmeformulation.com
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