Associate Director Regulatory Affairs - Strategy
Purdue Pharma L.P. and its subsidiaries develop, manufacture and market medications and consumer health products to meet the evolving needs of healthcare professionals, patients, and caregivers. We were founded by physicians and we are currently led by a physician. Beyond our efforts to provide quality medications, Purdue is committed to supporting national, regional and local collaborations to drive innovations in patient care. Privately held, Purdue is pursuing a pipeline of new medications through internal research & development and strategic industry partnerships.
For close to two decades Purdue has engaged in many initiatives to stem prescription opioid abuse. We are committed to bringing lifesaving relief to communities and individuals suffering from substance use disorder and overdose. We are currently developing or supporting the development of two essential life-saving opioid overdose reversal medications and have the capability to manufacture others for medication assisted treatment. Providing these medicines has the potential to improve and save countless lives.
We are driven by our purpose: Compassion for patients and excellence for science inspire our pursuit of new medicines.
We are building an exciting path forward, and we are committed to recruiting a dedicated team of professionals who advance our expertise through a commitment to Purdue’s Values: Integrity and Courage, underpinned by Innovation, and always in Collaboration with each other.
At Purdue Pharma and our subsidiaries, you have a unique career opportunity to work differently, uncover and seize new opportunities, and take a hands-on, ownership approach to your work. We go beyond traditional roles and find creative ways to extend our skills and interests, challenging ourselves to contribute in different, meaningful ways. We strive to create an environment where you can bring your best to work each day. We welcome the opportunity to have you on our team!
Under the guidance of the Exec Director, Regulatory Affairs and the Director, Regulatory Strategy, the incumbent will provide strategic Regulatory guidance for Purdue development projects, across a broad range of therapeutic areas and in the disciplines of non-clinical, CMC and clinical development. Such guidance includes all regulatory interactions with regulators/agencies including IND and NDA submission and approval, written correspondences and in person meetings/interactions. In addition, the incumbent will serve as the regulatory representative for Purdue on multiple assigned projects. As such, the individual is responsible for the assessment and progression of product candidates from both internal and external sources; preparation and management of regulatory strategies and documents; and the execution of submissions for Purdue development and marketed products.
- For assigned areas, provide strategic Regulatory guidance for Purdue research and development projects in the areas of nonclinical, CMC and clinical development, IND & NDA filing, and approval.
- Lead written and in-person interactions with the FDA and other foreign health regulatory authorities (e.g. Canada, EU) on behalf of the Purdue and subsidiaries for all development programs and products.
- Develop and maintain a positive relationship with FDA divisions and individuals to support development activities for Purdue and subsidiary programs. This may include planning and conducting meetings with the Agency during any phases of development.
- Interpret and communicate regulatory expectations and requirements to internal and external stakeholders in order to execute program objectives in compliance with applicable regulations and project timelines.
- Collaborate with R&D and company committees on the status of projects and the proposed regulatory strategies.
- Provide guidance to development teams and senior management internal stakeholders in developing strategic direction for assets/indications, and advice for regulatory interactions.
- Act as regulatory representative on project teams by contributing to the development of project development plans and target product profiles.
- Interact with all functions within R&D, at all levels, including groups such as non-clinical research, CMC, Clinical Research, Clinical Operations and R&D leadership team
- Build and maintain strong working relationships with key cross-functional stakeholders, including, Commercial, Medical Affairs, Drug Safety, Corporate Business Development, and other key functions key to the success of product development.
- Maintain accurate regulatory submission information in the regulatory applications for assigned filings, submissions and projects. This includes activities such as submissions of amendments and final study reports, annual reports, responding to Agency requests for information, safety report submissions, and development and review of annual reports for assigned projects.
- Design and implement processes for gathering regulatory intelligence and raise awareness within the organization of current trends in regulatory development and enforcement
Education and Experience Requirements
- PhD, MD, or PharmD in a scientific discipline preferred, along with at least 5years of pharmaceutical industry experience; BS/MS requires 10+ years of relevant work experience.
- Minimum of 5-10 years’ experience in a Regulatory Affairs function, dealing with FDA; expert understanding of FDA and ICH rules, regulations, policies, guidelines and procedures is required, as well as an understanding of other US regulatory agencies (DEA, FTC, etc.), especially as they relate to drug development, labeling, and approval.
- Knowledge of FDA organization and personnel is desirable, as well as experience across a wide variety of therapeutic areas.
- Experience with preparing regulatory documents including new INDs, NDAs briefing packages, Investigator Brochures, safety reports, and other regulatory submissions as required.
Purdue Pharma L.P. & its Subsidiaries are an Equal Opportunity (EEO) and Affirmative Action Employer encouraging diversity in the workplace. Qualified applicants will receive consideration for employment without regard to their race, national origin, religion, age, sex, sexual orientation, marital status, gender identity, genetic information, disability, military, protected veteran status, or any other characteristic protected by local, state, or federal law. Protected veterans and qualified individuals with a disability may request a reasonable accommodation by emailing: email@example.com.
For more information about your rights under Equal Employment Opportunity, visit:
- Job Family Research & Development
- Pay Type Salary
- 201 Tresser Blvd, Stamford, CT 06901, USA