Nature and Scope
The Executive Director, Head of Regulatory Affairs will be responsible for providing regulatory expertise and leadership to ensure that the company meets its objectives. The candidate will be responsible for working with US and global health authorities as needed to appropriately position American Regent’s product portfolio while also ensuring efficient and compliant internal regulatory operations. The position entails collaborating with key stakeholders to establish a comprehensive regulatory strategy from project initiation through development, filing, approval and launch for the company. The role will require multi-disciplinary activity and ability to build cross-functional collaboration with leaders from different departments and bring actionable leadership to American Regent.
Essential Duties and Responsibilities
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
- As a senior leader, contribute to the strategic planning process and function as the collective voice of Global Regulatory Affairs, working with the development leaders within ARMD and Manufacturing to develop a strong regulatory strategy and commercially viable launch strategy for company’s future growth.
- Ensure that all Chemistry, Manufacturing, and Controls (CMC) regulatory submissions meet global standards and facilitate the successful development, approval, and commercialization of the ARI Product portfolio.
- Ensure alignment of CMC regulatory strategies with broader regulatory, clinical, and commercial objectives to support timely development and registration of products.
- Manage the preparation, review, and submission of high-quality CMC regulatory documents for human and veterinary registrations in the US and globally.
- In alignment with organizational goals, develop and lead the implementation of regulatory strategies for American Regent products and compounds throughout all stages of clinical and commercial development, identifying and communicating regulatory risks.
- In close partnership with Development, provide high-level regulatory input to help develop complex generic, First to File (FTF) and First to Launch (FTL) parenteral products. Lead the preparation and submission of New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), Investigational Drug (INDs) Applications, amendments, supplements, meeting requests, briefing packages, and other regulatory submissions in eCTD format in accordance with ICH, CFR, and current Regulatory Guidance for FDA submission. Support the development teams with appropriate FDA meetings and controlled correspondences.
- In close partnership with Development, provide high-level regulatory input to help develop New Animal Drug Application (NADA) and Abbreviated New Animal Drug Applications (ANADA). Support for these applications can include amendments, supplements, meeting requests, briefing packages, and other regulatory submissions in the requisite eCTD format (eSubmitter) and in accordance with applicable Regulation and guidance.
- Ensure that product regulatory history and correspondence is accurate and easily accessible to the product development teams for reference.
- In close partnership with Medical Team, provide strategic regulatory leadership for clinical development projects, including overall regulatory strategy, regulatory requirements for registration, and regulatory risk assessments and mitigations to ensure that all nonclinical and clinical programs (i.e. pharmacology, toxicology, and clinical trials) are appropriately informed and structured to meet regulatory requirements with a forward-looking mindset toward a product’s target product profile, and ultimate prescribing information. Effectively communicate required data to the FDA in eCTD or other required format in accordance with ICH, CFR, and current Regulatory Guidance for FDA submission eCTD format in accordance with FDA guidance’s.
- Serve as the Regulatory Thought Leader in Portfolio Management Committee meetings and for the development of New Drug Applications (NDAs), 505 (B) (2)s, Abbreviated New Drug Applications (ANDAs) and New Animal Drug Applications (NADAs).
- Assume strategic oversight of American Regent’s relationship with external collaborators like the Animal Health Institute.
- Establish and maintain effective relationships with regulatory agencies, especially the US Food and Drug Administration (FDA), EMEA, and Health Canada throughout the development of projects, including support for regulatory agency meetings, teleconferences, Advisory Committee meetings, etc.
- Lead Regulatory Due Diligence activities for any incoming BD opportunities.
- Harmonize submission dossiers across all manufacturing sites. Provide detailed monthly function area updates.
- Research, review, and interpret related product approvals, current regulatory guidance documents, and recent public Advisory Committee proceedings, to support the development of optimal regulatory strategies to support the successful submissions and achievement of target product labeling.
- Contribute to the organizational design of the regulatory affairs function and provide a lead role in the selection of resources (employees and/or contractors) required to meet departmental and corporate objectives, inclusive of translation, submission of regulatory documentation, and business/functional unit’s contacts with health authorities. Interface with key opinion leaders and consultants in the regulatory process.
- Mentor, coach, and manage direct and indirect reports at various geographic sites to foster professional development and talent retention. Develop a positive business/functional unit culture by promoting values that focus on patients, science, and bringing forward effective regulatory strategies. Develop robust Career Development Plan for everyone in the Department and identify and nurture next generation of leaders through continuous mentoring and feedback.
- Accountable for maintaining business/functional unit’s adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
- Perform any other tasks/duties as assigned by management.
Education Requirements and Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.
- Graduate degree in a scientific discipline is required, advanced degree is a plus.
- Proven track record of complex product development to include, NDA, ANDA,NADA and ANADA approvals.
- Requires a minimum of over 15 years of progressively responsible experience in a pharmaceutical, biotechnology, contract research organization, or related environment. Product development and R&D experience is a plus.
- 10 + years of prior leadership and management experience in a regulatory affairs role required.
- Hands-on experience required in all phases of regulatory submissions and direct experience interacting with FDA and other national health authorities. International registration experience is also highly desirable.
- Experience with Clinical Trial Applications (CTAs), and post-marketing/life cycle management (e.g., variations, renewals, labeling) preferred.
- Required experience in overseeing the standardized assembly, review, publication and archival of regulatory submissions. Familiarity with the Center of Veterinary Medicine’s phased submission process is desirable.
- Experience with the creation, assembly, and publication of Chemistry, Manufacturing and Control (CMC) submissions a plus.
- Familiarity with eSubmitter is highly desirable.
- Demonstrated track record of success building relationships with, and influencing, regional and/or national health authorities, particularly in situations requiring direct interaction, negotiation, and effective communication skills (written and verbal).
- Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines. Ability to positively influence without direct authority. Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
- Travel requirements, international or domestic, approximately 10-25%.
Expected Salary Range :
$275,000 - $325,000
The salary range, displayed is the minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate’s qualifications, education, knowledge, skills and experience.
American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide
range of other benefits.
American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.
Applicants have rights under Federal Employment Laws.
American Regent Inc. endeavors to make https://americanregent.com/Careers accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com.
