Roles and Responsibilities:
- Experience in handling regulatory affairs for ROW market mainly Latin American, African & Asian countries for Pharma Formulations.
- Preparation, compilation & Review of Registration documents that include Administrative & Technical.
- Reviewing the technical documents provided by QA, QC, Production Providing them the report of shortcomings & ensures them to correct the documents.
- Handling RFIs (Requested Further Informations) queries raised by Importer/ Agent/ Regulatory authorities during evaluation of technical data.
- Coordinating concerned (QA, QC, Production, Packing & Purchase) departments in the process of sample preparation.
- Coordinate & submission of CTD/ACTD/Country Specific Dossiers/DMF (OP) to regulatory agencies.
- Coordinate & provide support to team for preparation and dispatch of regulatory documents & dossiers in agreed time-frames.
- Responsible for planning, coordinating and managing day to day regulatory affairs activities in a timely manner.
- Providing technical knowledge of the data used in CTD, ACTD & Dossiers to members of regulatory team.
- Fill up customer questionnaires by collecting information from various concerned departments.
- You should be good in man - management & co - ordination with all the departments Interact with various administrative, legal & factory departments to collect documents required for regulatory compilation on time.
- Maintenance of the complete history of each drug product.
Desired Candidate Profile:
As per the job Description mentioned.
Role:Regulatory Affairs Compliance
Salary: Not Disclosed by Recruiter
Industry:Pharmaceutical & Life Sciences
Functional AreaLegal & Regulatory
Role CategoryCorporate Affairs
Employment Type:Full Time, Permanent
UG:B.Pharma in Any Specialization
PG:M.Pharma in Any Specialization
finecure pharmaceuticals ltd
Finecure Pharmaceuticals Limited and its subsidiaries are leading manufacturers and marketers of Pharmaceutical formulations and Nutraceuticals in several therapeutic segments in dosage forms of Tablets, Capsules, Oral Liquids, Dry Syrup, Powders, Injections and Sachet. Finecure has several accolades to its credit including the following:
- International Arch of Europe Award" 2012 - Germany,
- Assocham India Business Excellence Award - 2013,
- Healthcare &Pharmaceuticals Award UK-2015,
- IPE-Fastest Growing Pharma Company Award-2015,
- Pharma Company of the Year (Operational Excellence) - 2016,
- Dreams Companies to work for, Times Ascent - 2016,
- Dream Companies to work with in Feb 2021.
The Company is poised for vertical growth, with modern facilities, skills and knowhow and resources that are at par with the best in the country. The company has state-of-the-art manufacturing facilities and maintains all specific set of standards mandated by the Food and Drug Administration (FDA). The company is certified for WHO GMP, ISO 9001, ISO 22001, ISO 14001, OHSAS 18001 quality systems towards High Product Quality Assurance, Environment Management System, Occupational Health and safety. The Company is CRISIL 1A rated towards "Highest Performance Capability" and "High Financial Strength" and is maintaining a Double digit growth rate. Finecure has shown an annual growth of 50% in the last fiscal year and 36% compounded annual growth (CAGR) indicating company's strategic policy implementation and performance strength.The company continues to explore avenues of growth and development through SBU's focusing on the Domestic and Export Markets. Backed by a determined administration, a resolute workforce, state-of-the-art work environment, an effective R&D and F&D department and strong ethical values, the company is poised to take significant strides towards further progress and accomplishment. Finecure runs on principles of quality management systems as per EFQM guided by its mission, vision, values and ethics which act as role models. The company ensures Environment Safety, Health and Hazard Risk Management and CSR. Finecure has received many honours, awards and testimonials, from prestigious organizations like FICCI, ASSOCHAM, IDMA and Pharmexcil acknowledging their excellence in the pharmaceutical market Since inception, superlative production values stemming from Finecure's Commitment to quality in pharma products earned us a global acclaim. The company is PIC/S compliant. The company is moving towards a long term goal of discovery, development, manufacture, marketing and sales of novel drugs.