Amneal Pharmaceuticals

Executive, Regulatory Affairs

Amneal Pharmaceuticals  •  State of Gujarāt, IN (Onsite)  •  2 days ago
Apply
AI can make mistakes so check important info. Chat history is never stored.

Job Description

  • Good knowledge of ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines.
  • API DMF and DMF Change Notification review with respect to USFDA regulatory requirement.
  • Exposure of the Solid oral dosage form / Sterile dosage form / complex dosage form / topical-Inhalation dosage form and brief manufacturing process and key regulatory aspects.
  • Ability to preliminary review the change cases with respect to ICH quality / post approval USFDA guidance and aware for Post approval submission guideline and procedure for Annual report/CBE 0/CBE 30 and PAS filling
  • Drafting of the Annual Report with required submission data as per USFDA guidance.
  • Preliminary review of entire submission package.
  • Drafting the controlled correspondence/Briefing Package to FDA on specific cases as needed for assigned projects.
  • Awareness about the FDA recommendation on the commercial marketing status notification submission in terms of content and time frames.
  • Coordination with Cross Functional teams for the documents availability as per regulatory submission plan.
  • Ensure the no delay in drafting and compiling the regulatory submission.
  • Maintain regulatory information as per allocated task.
  • Having good Regulatory CTD modules drafting & preliminary review skills.



Additional Responsibilities:

Education:

  • B. Pharm B. Pharm - Required
  • M. Pharm M. Pharm - Preferred

Experience:

  • 5 years or more in 5 - 8 Years

Specialized Knowledge: Licenses:

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.

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.

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