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Director, Regulatory Affairs - Oncology

Date: Jan 29, 2019

Location: Stamford, CT, US, 06901

Company: Purdue Pharma L.P. & Affiliates

Job Summary

Under the guidance of the Head of Regulatory Affairs, the incumbent will primarily provide strategic Regulatory guidance for Purdue development projects, especially related to the therapeutic area of oncology in the areas of clinical development and NDA approval.  In addition, this person is the regulatory representative for Purdue on multiple assigned projects.  As such, the incumbent is responsible for the assessment of product candidates both from internal and external sources; preparation and management of regulatory strategies; and the execution of submissions for Purdue development and marketed products.

Primary Responsibilities

  • Provide strategic Regulatory guidance for all Purdue development projects, especially related to the therapeutic area of oncology in the areas of clinical development, IND filing, and NDA approval. 
  • Lead interactions with the FDA and other foreign health authorities (e.g. Canada, EU) on behalf of the organization for all development programs and products.
  • Develop and maintain a positive relationship with FDA, and interact with the respective groups at the Agency, both informally and formally to support development activities for Purdue programs.  This will include planning and conducting meetings with the Agency during all phases of development.
  • Interpret and communicate regulatory expectations to internal and external stakeholders in order to execute program objectives in compliance with applicable regulations.
  • Guide internal stakeholders in developing strategic direction for assets/indications and provide leadership for regulatory interactions.
  • Collaborate with R&D and company committees on the status of projects and the proposed regulatory strategies.
  • Provide regulatory advice to development groups.  Act as regulatory representative on project teams and provide regulatory strategy on projects by contributing to the development of project development plans and target product profiles.
  • Interact with the various departments, including groups such as Clinical Research, Preclinical Research, Business Development, Drug Safety and Pharmacovigilance, Commercial, as well our international colleagues.
  • Responsible for regulatory issues regarding their assigned developmental and marketed products.  This includes all aspects of internal team meetings and preparation of submissions necessary for the advancement of the project or resolution of issues.
  • Maintain regulatory applications.  This includes activities such as submissions of amendments and final study reports, responding to Agency requests for information, safety report submissions, and development and review of annual reports for assigned projects.
  • Build and maintain strong working relationships with key internal stakeholders, including R&D Leadership team, Commercial, Medical Affairs, Drug Safety, Corporate Business Development, and other key functions key to the success of product development.
  • 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

  • PhD, MD, or PharmD in a scientific discipline preferred, along with at least 10 years of pharmaceutical industry experience; BS/MS requires 15+ 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 in the oncology and associated therapeutic areas.
  • Experience with preparing regulatory documents including new INDs, NDAs briefing packages, Investigator Brochures, safety reports, and other regulatory submissions as required.

Necessary Knowledge, Skills, and Abilities

  • Must be capable of developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities.
  • The position requires the ability to work under defined and often tightly regulated time frames required by law and corporate needs. 
  • The ability to apply the knowledge of FDA and other regulatory agency regulations and policies and develop novel approaches to resolve product development complications is a necessity in order to obtain rapid product approvals and ensure compliance with all laws and regulations affecting the pharmaceutical business. 
  • The ability to evaluate FDA precedence and trends, as well as the competitive environment, is critical to success.
  • Capability to identify potential regulatory risks to the strategic/operational plans and propose options to mitigate risk.
  • Must effectively communicate with internal project teams and R&D, Medical and corporate leadership committees regarding regulatory strategy. 
  • Ability to lead and facilitate meetings with regulatory agencies and prepare internal teams for these interactions; demonstrated ability to build strong relationships with FDA
  • The position requires sound judgment and common sense considering the economic and legal consequences of inappropriate actions/conduct. 
  • Ability to problem solve and drive decision making around complex regulatory, preclinical, clinical issues with internal project teams.
  • Strong verbal and written communication skills; ability to clearly articulate regulatory viewpoints to a diverse audience.
  • Ability to thrive in a collaborative and ever-changing team environment.

Supervisory Responsibilities (if Applicable)

The incumbent initially will not have any direct reports, but may supervise exempt and non-exempt employees as assigned, both inside of Regulatory and in related cross-functional departments.

Additional Information

Nearest Major Market: Bridgeport
Nearest Secondary Market: Danbury

Job Segment: Regulatory Affairs, Manager, Law, Pharmaceutical, Compliance, Legal, Management, Science