Regulatory Affairs ( Deputy Manager) @ BVR People

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Regulatory Affairs ( Deputy Manager)

BVR People
7 - 10 years
Hyderabad
4 years ago
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Job Description

Job Title: Regulatory Affairs ( Deputy Manager)

Company: Leading Pharma Company in Hyderabad Location

Designation: Deputy Manager

No. of Positions: 2

Division: API Bulk Drugs

Department: Regulatory affairs

Location: Hyderabad Location

Qualification: B.Pharma/ M.Pharma

Years of Experience: 7 to10 Years

Salary Range: 10 LPA

Contact Person:

Mr.Zabi Mogal

Mobile: 7676936***

Email ID: za*i@bv**c.com

Job Description:

1. Good scientific conceptual background to the level to review the documents in the area of Quality, R&D, AR&D and Production.
2. Collecting and reviewing the documents received from various departments R&D, AR&D, QA, QC and Production etc at each and every stage of manufacturing of drug substances to minimize the errors at the time of submission to regulatory agencies.
3. Thorough review and ensuring that the regulatory submissions are adequate and error free with minimum open issues and closing of open issues before filing or before the receipt of deficiencies.
4. Hands on experience on preparation & review of drug master files, Applicants Parts, Tech Pack, life cycle management [updates and amendments] and drafting of response to deficiencies and customer DMF review comments for all global regions.
5. Hands on experience on the preparation of DMFs and their registration processes in the major regulatory regions [US, Canada, Europe, China etc].
6. Thorough knowledge and hands on experience on the DMF registration and marketing authorization application systems in the major regulatory regions [US, Canada, Europe etc]..
7. Should have hands on experience on eCTD regulatory submission tools.
8. Conducting meetings for the deficiencies received from various regulatory agencies and should have knowledge on the requirements to respond to the deficiencies. Ensuring that the accurate and adequate responses are sent to the authorities within the timelines defined by agencies.
9. Should have knowledge on product developmental and the quality systems to ensure the regulatory compliance.
10. Participation in the cross functional team meetings and providing regulatory inputs to the Product Development Teams.
11. Preparation of Genotoxic impurities report based on Muller alerts, toxicity data available during development stage itself.
12. Good knowledge on the regulatory and quality guidelines from various regulatory agencies ICH, FDA, EMA, Health Canada, ANVISA, PMDA, MFDS, CFDA etc.
13. Review and assessment of change controls and providing guidance to the team on proposed changes.
14. Ensuring that the regulatory databases are properly maintained and updated on time to time for each regulatory activity
15. Good communication skills in English for discussions with-in the organization and with customers.
16. Assessment of CMC sections received for intermediates and provide regulatory strategies for submissions in major markets US, EU, Canada

17. Provide guidance/support to junior teammates and to be a good team player.

Job Classification

Industry: Pharma, Biotech, Clinical Research
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology,
Role Category: Drug Regulatory Affairs/Documentation
Role: Drug Regulatory Affairs/Documentation
Employement Type: Full time

Education

Under Graduation: B.Pharma in Pharmacy
Post Graduation: M.Pharma in Pharmacy
Doctorate: Doctorate Not Required, Any Doctorate in Any Specialization

Contact Details:

Company: BVR People Consulting (Pharma Companies)
Location(s): Hyderabad
Website: http://careers.bvrpc.com

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Keyskills: Canada life cycle management Regulatory Affairs Pharma Europe China LCM Bulk Drugs USDMF DMF US RA

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BVR People

Company ProfileBVR People ConsultingBVR people consulting committed to help Organisations to realise and develop their full potential in order to compete in the present day globalised and technology driven business environment. BVRPC invigorates the key components of organizations - The People and...

Regulatory Affairs ( Deputy Manager) @ BVR People

Home > Drug Regulatory Affairs / Documentation