Regulatory Affairs (US Markets) For Leading
- BVR People
- 4 to 9 Yrs
- Mumbai
- 3 years ago
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Job Description
Roles and Responsibilities
Job Title: Regulatory Affairs (US Markets) New Product Submission
Company: Leading Pharma Company in Mumbai Location
Designation: Executive to Assistant Manager
Reporting to: Manager
No. of Positions: 2
Division: Formulation
Department: Regulatory Affairs
Job Location:Mumbai Location
Qualification: MSc /B.Pharma/M.Pharma (Full Time)
Years of Experience: 2 to 9 Years
Salary Range: 5 LPA to 13 LPA (Max)
Contact person: Mr.Zabi Moghal
Mobile: 8105301***
Email: za*i@bv**c.com
Job Responsibilities:
1. Review, compilation and timely submissions of applications (i.e., ANDA, NDA and ANDS) of drug products to Health authorities of US and Canada market.2. Perform detailed review of all technical documents required for compilation of New Product Submission (NPD, ANDA/ANDS), Pre-launch variations and query responses.
3. Building dossier/applications into eCTD format and ensure documents meet strict internal and regulatory standards.
4. Ensure dossier/documents are of high-quality standard to ensure one cycle review from Regulatory authorities.
5. Handling of Common Electronic Submission Gateway (ESG) for submission of applications for US & Canada market.
6. Responsible to respond to queries received for assigned products from regulatory authorities (US & Canada) within given timeline & with high quality.
7. Co-ordinate with third party manufacturers for document requirement and query response (as required).
8. Timely communication and follow up with the respective departments for compilation and submission of query responses to meet agreed timeline.
9. Review and maintenance of change controls and customer notifications related to the Co-development projects.
10. Preparation, review and timely submission of supplements/variations (CBE, CBE-30, PAS, sANDS and Level -III) to Health authorities.
11. Works as a member of a team to achieve all outcomes.
12. Perform all work in support of our values of Collaboration, Courage, Passion and Perseverance; Demonstrates strong and visible support of our values.
13. Performs all work in accordance with all established regulatory compliance and safety requirements.
14. Provides regulatory support to internal functional departments and product development teams.
15. Adherence to the responsibilities as assigned by Senior Manager / Group/ Team Leader Regulatory Affairs.
16. Adherence to regulatory guidelines published by US & Canada market.
Industry: Pharmaceutical & Life Sciences
Functional Area: Medical , Healthcare , R&D , Pharmaceuticals , Biotechnology
Role Category: Drug Regulatory Affairs/Documentation
Role: Regulatory Affairs Manager
Employment Type: Full Time, Permanent
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Employement Category:
Employement Type: Full timeIndustry: Pharma / Biotech
Role Category: General / Other Software
Functional Area: Not Applicable
Role/Responsibilies: Regulatory Affairs (US Markets) For Leading
Contact Details:
Company: BVR People ConsultingLocation(s): Mumbai
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...
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