Amneal Pharmaceuticals

Deputy Manager, Regulatory Affairs

Amneal Pharmaceuticals  •  State of Gujarāt, IN (Onsite)  •  4 days ago
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Job Description

  • Prepare, Review and Finalize Regulatory strategies for Complex Products [like injectables that may include Peptides, Microspheres, Liposomes, Nano-suspensions etc./ Ophthalmic/ Otic/ Topical gel/ DDCP etc.] and 505(b)(2) Products for US and EU market.
  • Draft, Review and Finalize Pre-ANDA/Pre-IND/ScA meeting packages for US and EU market.
  • Draft and finalize controlled correspondences on complex issues.
  • Draft, Review and Finalize Deficiency responses for Complex Products and 505(b)(2) Products.
  • Review API and FP in-vitro characterization/sameness reports.
  • DMF review for complex APIs as per the workflow.
  • To collaborate and work closely with cross functional teams.
  • To meet the management expectations w.r.t timelines and quality.
  • To work closely within the team and provide training to new members on new regulatory requirements for Complex products.
  • Suitably qualified individuals with strong Scientific and Regulatory background.
  • Academic degree in Pharmacy (M. Pharm or PhD), with preferably specialization in Regulatory Affairs or Pharmaceutics.
  • Experienced (minimum 8-10 years) in Regulatory Affairs with Injectable dosage form and overall experience 12+ years.
  • End to end complete understanding of Complex Products for US/ EU market right from Strategy, Filing, Deficiency response etc.
  • Experienced in drafting controlled correspondences, Meeting packages etc.
  • Experience being an active contributor to cross-functional teams and/or working in matrix organizations. High quality, critical thinking, process, and performance orientated; prioritizes activities and projects.
  • Exercises good judgment on regulatory, quality, and technical related compliance issues. High personal integrity; trustworthy; strong compliance and quality mind-set.
  • Solution orientated, strong sense of ownership and accountability.
  • Collaborative, team-oriented approach, capable of working cross-functionally, and in a matrixed and integrated way.

Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.

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
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