Regulatory Affairs Manager
- Rank File
- 8 to 13 Yrs
- Chennai
- 5 years ago
- Email to a friend
- Report this job
Job Description
URGENT REQUIREMENT FOR QUALIFIED AND EXPERIENCED REGULATORY AFFAIRS SPECIALIST FOR FAST GROWING, FINISHED FORMULATIONS CO.
QUALIFIED CANDIDATES WITH RELEVANT EXPERIENCE IN REGULATORY AFFAIRS FOR SEMI-REGULATED AND ROW MARKETS MUST RESPOND WITHIN 7 DAYS WITH FOLLOWING DETAILS.
- UPDATED COMPLETE RESUME
- PRESENT ANNUAL CTC (all inclusive)
- EARLIEST JOINING PERIOD
- SUMMARY / BRIEF CHART OF COUNTRIES / REGIONS FOR WHICH YOU HAVE PREPARED CTDs & FOLLOWED UP FOR REGULATORY COMPLIANCES (mention specifically for regulated / un-regulated / ROW markets). This will assist the co. in evaluating your experience.
Position
Manager / Asst Manager Regulatory Affairs
Location
Porur, Chennai
Products
Finished formulations
Salary
4 to 5 lakhs pa all inclusive
Work week
Sundays off
Company profile:
- Our client is a Rs 75 crores, fast growing co. in manufacturing finished formulations with headquarters in Mumbai and modern plant in Tamil Nadu.
- The co. manufactures a range of tablets, ointments, liquid and syrups
- It offers good work environment with scope for growth
Job Responsibilities:
- Monitoring day to day work allocation to subordinates.
- Preparation, review and submission of the ACTD (ASEAN Common Technical Dossier), CTD and country specific dossiers as per the current prescribed guidelines of the respective regulatory authorities (registration and re-registration)
- Responsible to prepare dossiers for ROW & Semi Regulated Market & should be well versed with its regulatory guidelines.
- Handling technical / administrative queries pertaining to regulatory submission and responding them on time.
- Co-ordination with R&D, QA, QC, Packing & Production for regulatory requirements for dossiers submission and approval.
- Arranging the samples and attested legal certificates (GMP, FSC, COPP, mfg licence, product license) for registration purpose.
- Review of the quality and analytical data as per the pharmacopeia, specifications MOA, STP, batch records, stability, finished product / packing material data, BA/BE study for the purpose of compilation of the dossier.
- Update the management about the regulatory status periodically
Candidate profile:
- Graduate / PG in Chemistry / Pharma with minimum 8 years experience in QA / AMD / regulatory affairs with at least past 4 years specifically in RA in any reputed medium to large finished formulations pharma cos.
- Proficient in understanding of regulatory requirements of different regions, generating and gathering relevant data, analysis, inter-department coordination and preparing accurate reports and dossiers as per region / country specific compliances.
- Specific experience of handling similar responsibilities for SEMI-REGULATED, UNREGULATED ROW markets is essential.
- Should have excellent and oral skills with proven experience of communicating & following up with international buyers / regulatory authorities
- Should be able to handle all licensing procedures at both Central and state Drug control authorities:
- Work may require some travel locally / abroad for product registration follow-up
- Ideal age profile: 30 to 40 years
Employement Category:
Employement Type: Full timeIndustry: Pharma / Biotech
Role Category: Quality (QA-QC)
Functional Area: Not Applicable
Role/Responsibilies: REGULATORY AFFAIRS MANAGER
Contact Details:
Company Name: Rank FileLocation(s): Chennai
+ View Contact
Fraud Alert to job seekers!
₹ 3.5 - 5 Lakh/Yr
Similar positions
Job Listings
We are in open beta version of website, please let us know if any issues, at: info(at)indigojobs.in
