Job 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

QUALIFICATIONS

Education

Experience:

Specialized Knowledge: Licenses:

Manager, Government Relations

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