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Manager, Government Relations at Amneal India
Ahmedabad, gujarat, India -
Full Time

Start Date

Immediate

Expiry Date

21 Aug, 26

Salary

0.0

Posted On

23 May, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Government Relations, Regulatory Compliance, CDSCO Approvals, FDA Licensing, Narcotics Regulations, FSSAI Registration, Strategic Planning, Stakeholder Management, Technical Documentation, Communication Skills, Sugam Portal, NSWS Portal, IDML Portal, IFP Portal, Unified CBN Portal, FOSCOS Portal

Industry

Pharmaceutical Manufacturing

Description
- Need to have good understanding of the D & C Act, CDSCO Guidance for Industry, Gujarat Prohibition acts and NDPS Acts. - Strategize, submit and Obtain approvals from CDSCO i.e. FORM 11, CT 17, CT 04, CT 21, CT 18, Form 10, MD 5, MD 6, MD 17, MD 15, Dual NOC in timely manner. - Strategize, submit and obtain approvals from Prohibition and excise department i.e. Product approvals under RS II, MA I, DS V and AC II  - Strategize, submit and obtain approvals from State FDA i.e. Test license, Manufacturing license, Export/Domestic License, COPP, FSC, Loan License, WHO GMP, State GMP/GLP. - Strategize, submit and obtain approvals from CBN i.e. Export Authorizations and Import Authorizations. - Additionally, must have knowledge about FSSAI registration and licenses. -Work Closely with R & D, Quality Unit, Manufacturing, Supply Chain & Logistics in providing regulatory inputs during product development to clearly communicate the regulatory requirements for securing the necessary licenses/approvals in India and for global submissions. - Well versed about the Online portal i.e. Sugam, NSWS, IDML, IFP, Unified CBN, Prohibition and Excise and FOSCOS portal. - He/She should be able to handle the queries raised by the aforesaid government department. -Need to possess good communication. Additional Responsibilities:
Responsibilities
Strategize and obtain necessary regulatory approvals and licenses from CDSCO, State FDA, and other government bodies. Collaborate with R&D, Quality, and Manufacturing units to provide regulatory inputs for product development and global submissions.