Senior Manager, Regulatory Affairs
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) is an integrated specialty pharmaceutical company powered by a robust U.S. generics business and a growing branded business. The company has a noble and important mission: We make healthy possible.
Amneal is one of the fastest growing pharmaceutical companies in the U.S. and makes healthy possible through its diverse product portfolio that includes more than 200 generic product families, 5 marketed specialty products, and a portfolio of biosimilars, one of which has been filed with the FDA, one near-term filing opportunity and one in late-stage development.
Additionally, Amneal has impressive R&D capabilities that have resulted in one of the industry’s largest generics pipelines with 258 products filed or in development, one investigational drug to augment the Specialty business, and three biosimilars in various stages of development. Amneal’s product range spans injectables and steriles, topicals and transdermals, solid and liquid dosage forms and inhalation delivery systems.
Following its May 2018 combination with Impax Laboratories, Amneal is uniting its 6,500 employees worldwide - who are based across the US, India, and European locations – around its Learn, Lead, Succeed culture. This dynamic entrepreneurial culture encourages all employees to contribute, to work together and to balance strategic thinking/risk taking with the need to achieve results.
As integration work continues, the company is centralizing much of its leadership and key functions in the Bridgewater, NJ area, including most of the R&D function. This has resulted in the need to hire several key roles to ensure the continued growth of the business and bring the function together, thereby enabling operational efficiency, close collaboration within the team, and the sharing of ideas and values.
From a Specialty Pharma perspective, Amneal has two large Ph III studies underway for the treatment of Parkinson’s Disease and one Ph IV study for pediatric usage of Zomig. However, Amneal is aggressively continuing to pursue growth through its business development initiatives, and it is anticipated the Clinical Product Pipeline will be greatly expanded in the near future.
The Senior Manager Regulatory Affairs, Specialty Pharma will assist in determining the regulatory strategies of all branded products in clinical development.
He/she must execute regulatory and related strategies to gain regulatory approval in the US and global markets, and manage submissions to, and communications with, the FDA, EMEA and other Health Authorities.
The successful candidate will work closely with cross functional counterparts including Clinical, Commercial and colleagues across the R&D organization to set strategy and support all post-launch activities from a regulatory perspective. In additional, s/he will:
• Assist the Regulatory team in providing strategy execution and supervisory responsibilities for the branded development projects.
• Interact with all stakeholders within CDMA (Clinical Development and Medical Affairs), Regulatory Affairs Corporate Operations, CMC and Clinical Operations and CRO’s.
• Support pre-IND, IND, NDA and post approval activities.
• Liaise with the FDA for determining Regulatory strategies, communications and coordination of meetings.
• Review and approve submission of advertising and promotional material.
• Review and approve labeling revisions and controls for branded products.
Professional Experience / Qualifications
• The ideal candidate will have 5+ years of early and late stage development pharmaceutical products, ideally in the neurology therapeutic area.
• Clinical development regulatory experience with the US NDA/IND, European CTA and MAA; as well as any other relevant marketing countries.
• Review of clinical protocols, clinical study reports, Chemistry, Manufacturing and Controls documents with respect to alignment with program strategy and consistency of scientific interpretations/messages, clarity, completeness, and regulatory requirements. Will have successfully filed NDA’s.
• Proactively identify program issues and implement appropriate regulatory strategies to mitigate risks.
• Strong leadership and organizational skills, written and verbal communication skills, and interpersonal skills with the ability to effectively influence diverse internal and external customer groups at various levels within organizations (articulate and persuasive).
• Team player, ability to work well within cross-functional teams and in a multicultural/ multinational environment.
• Excellent communication skills.
MS/PhD in Pharmaceutical Sciences preferred with at least seven years of pharmaceutical experience in preparation of Regulatory submissions.