Amneal Pharmaceuticals

Assistant Manager, Regulatory Affairs

Amneal Pharmaceuticals  •  State of Gujarāt, IN (Onsite)  •  7 days ago
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Job Description

Qualification: M.Sc. Chemistry or M.Pharm

Experience 8 -15 yrs

  • Scientific review of external API vendor’s DMFs in context of ANDA/NDA & resolving any gaps.
  • Preparation & review of ANDA/NDA Drug Substance Modules & related activities.
  • Preparation of project status & updates for discussion in next level.
  • Assessment of change controls & vendor notifications.
  • Technical writing of deficiency responses, modules & other scientific regulatory documents, as required.
  • Participation in project meetings, coordination with CFTs, good communication & coordination.
  • Supporting Europe & Canada market due diligence projects for Drug substance part, as required.
  • Knowledge of current regulatory guidelines is required.
  • Experience of complex APIs will add value.
  • Knowledge of using AI in routine work will add value.
Amneal Pharmaceuticals

About Amneal Pharmaceuticals

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.

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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.

Industry
Chemicals & Materials
Company Size
5,001-10,000 employees
Headquarters
Bridgewater, New Jersey
Year Founded
2002
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