- 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:
Education:
Experience:
Specialized Knowledge: Licenses:
Amneal (NASDAQ: AMRX) is rapidly becoming one of the most dynamic, purpose-driven pharmaceutical companies delivering more affordable access to essential medicines. Our family delivers for yours through a robust U.S. generics business, a growing branded business and deepening portfolios in injectables, biosimilars and select international markets. We’ve bolstered our world-class scientific rigor, production capabilities and commercial infrastructure. And we invest substantially in our people through leadership development and employee well-being programs – all so we can deliver even more value. We are Amneal and We make healthy possible.
Content is for informational purposes only and 3rd party content does not reflect Amneal’s opinions.
Amneal has the right to remove comments that violate another’s copyright or intellectual property, mention an Amneal product, use profanity or are defamatory, promote and solicit for third-party sites, initiatives, or products, or are factually inaccurate or misleading or spam.
Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or drugsafety@amneal.com. If you are currently experiencing a life-threatening event, please immediately contact 911.
