Senior Director 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 the majority 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 Director Regulatory Affairs will determine the regulatory strategies of all products in clinical development, and play a leading role in translating regulatory requirements into practical, workable strategies and plans for development and commercial stage drugs.
He/she must implement regulatory and related strategies to gain regulatory approval in the US and global markets, and manage submissions to, and communications with, the FDA, EMA 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:
- Possess the ability to analyze and interpret clinical and nonclinical information to formulate successful regulatory strategies.
- Review and approve submission of advertising and promotional material.
- Review and approve labeling revisions and controls for branded products.
- When required, provide regulatory opinion, reflecting Regulatory Affairs practice, philosophy and policy to the senior R&D team.
- Advise on the development and implementation of regulatory strategy through the non- clinical, clinical, manufacturing and other processes; specify potential risks and respond to new government/regulatory developments.
- Maintain current knowledge of regulations and guidelines (FDA, EMA, ICH, PMDA and others as required). Lead multi-disciplinary teams in the authoring of regulatory communications such as regulatory briefing packages.
- Ensure internal and any external resources are optimal to support all relevant initiatives; interact with senior level regulatory counterparts at partner companies, contract manufacturers and regulatory agencies.
- In collaboration with members of the R&D team, perform/manage critical analyses of data (clinical, preclinical and manufacturing), and independently develop interpretations and conclusions.
- Evaluate industry organizations and governmental agency initiatives and prepare company responses.
- Oversee preparation of regulatory presentations for internal governance meetings.
- Establish a network of internal stakeholders and develop a close working relationship to ensure that Regulatory Affairs is recognized as a valued strategic partner in the development and commercialization of products.
Professional Experience / Qualifications
- The ideal candidate will have 10 - 12 years of regulatory experience and have successfully filed NDA’s.
- Have worked closely with colleagues to develop a Regulatory strategy.
- 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.
- Proactively identify program issues and implement appropriate regulatory strategies to mitigate risks.
- Oversee and ensure compliance with regulatory procedures and work practices.
- Demonstrated experience and ability to successfully interact and negotiate with senior FDA/EMA/International Regulatory Agency reviewers on NDA issues, and with external vendors/partners on key issues.
- Deep knowledge of US/EMA/international regulations, GCP requirements with demonstrated track record of filing successful license applications (NDA) and electronic submissions in all phases of development and post approval.
- Experience supporting global clinical studies with expert knowledge related to drug development requirements, GCP requirements and standards for clinical trials.
- Aptitude for working with project teams and strong ability to communicate with all key internal and external stakeholders in key governmental agencies.
- Excellent leadership and organizational skills, written and verbal communication skills, and interpersonal skills with the ability to effectively influence many diverse internal and external customer groups at various levels within organizations (articulate and persuasive).
- Experience with late-stage development/marketed products.
- Direct interaction/negotiation with regulatory authorities (e.g. FDA, EMA).
- Team player, ability to work well within cross-functional teams and in a multicultural/ multinational environment.
- Excellent communication skills.
MS/PhD in Pharmaceutical Sciences with at least ten years of pharmaceutical experience in preparation of Regulatory submissions.