Forest Research Institute (FRI)
—a wholly-owned subsidiary of Forest Laboratories, Inc.—drives the scientific research and development behind Forest’s top-quality therapies that help people lead healthier, more fulfilling lives. With operations in Jersey City, NJ and on Long Island, plus clinical trial personnel across the country, the Institute’s highly skilled professionals enable Forest to license compounds at virtually any stage—from preclinical development to products that are ready for FDA review—and then complete the development and regulatory work to successfully bring vital new therapies to market. Each of Forest’s more than 5,000 employees—including our 1,000 person strong Research Institute—contributes to our quest to deliver quality products with entrepreneurial spirit, integrity and deep respect for people and community. Explore your potential to thrive with a career at Forest.
The role of the Senior Director, Regulatory Affairs is to provide expert leadership and managerial oversight for assigned team and projects to ensure delivery of high quality regulatory strategy and submissions. Further, this position will guide development programs to anticipate changes in the regulatory environment and approval requirements. Will serve as a credible, influential, respected corporate spokespersons during interactions with regulators and regulatory agencies in the United States and will provide mentoring and leadership for team during interactions with FDA. Responsibilities may additionally include direct assistance to department head on assigned projects, supervision of due diligence projects for team, and team mentoring
Provide leadership and oversight for strategic regulatory review processes, on assigned programs and initiatives. Advise on strategic regulatory issues pertaining to the drug development lifecycle including pre-clinical, clinical, and post-marketing activities.
Guide regulatory strategies for worldwide compliance and submissions, from development through marketing, including advertising, promotion, and labeling, in an environment committed to the efficient development of new drugs for patients.
Initiate and ensure appropriate responses to agency review issues to ensure expedient and efficient review and approval of submissions while effectively managing issues as they arise.
Represent the Company in interactions with domestic health authorities, such as the FDA, as appropriate. Create a sound and positive image of Forest programs, develop trust and create strong working relationships within the FDA.
Maintain a vigilance of proposed changes and new regulatory legislation and actively communicate these matters to the appropriate internal parties. Suggest and collaborate on strategies for managing the change. Suggest areas of new opportunity brought about by these changes.
Draw upon knowledge/experience, provide strategic and tactical leadership in the business development/due diligence process.
Lead and manage direct reports within the Regulatory Strategist and Liaison (RSL) group.
Ensure sound regulatory practices are fully integrated in all pre-clinical, clinical and technical submissions, and evaluate all documents submitted to regulatory agencies to ensure they are complete, well organized, scientifically accurate, of high quality, in regulatory compliance and presented in a manner that facilitates agency review.
- Recruit, develop, and supervise direct reports. Assign projects appropriate to strengths and experience.
Have signatory prerogative for all documentation and approvals bearing responsibility for oversight by the Regulatory Affairs Department.
- Provide forum/environment for strong inter-team communication. Ensure team has upwards exposure to management and opportunities for professional growth.
- Conduct employee performance evaluations and encourage appropriate training for their professional goals/objectives.
Bachelor’s degree is required
Master’s Degree or higher (PhD, PharmD, MD, or JD) or equivalent experience preferred
Min. 10 years of pharmaceutical experience in Regulatory Affairs
Leadership experience with a proven track record of effectively managing direct reports is required
Experience with IND and NDA filings is required
Experience contacting the FDA and organizing FDA meetings is required
Experience with licensing and launching new products is a plus
Experience with FDA advisory committees is a plus
Experience with labeling negotiations is a plus
Knowledge, Skills, and Abilities
Thorough knowledge of the drug development process and laws and regulations affecting the pharmaceutical industry in the United States.
Knowledge of the policies, key personnel and regulatory climate at the FDA and other global health authorities (e.g., EMEA, HBP, KIKO), and significant experience in making regulatory presentations to such authorities.
Ability to read, analyze and interpret complex regulatory documents and to respond effectively to sensitive inquiries or complaints.
Strong technical background including proficiency in Microsoft Word, Microsoft Excel, Microsoft Powerpoint, Microsoft Outlook and Documentum
Must possess excellent skill/ability in the following:
Oral and Written communication
Forest Laboratories, Inc. - 12 months ago
Forest Laboratories doesn't just blend in with the trees. The company develops and manufactures prescription drugs to address a wide...