Promotional Regulatory Affairs Director, R&D – Malvern, PA
About Endo International plc
Endo International plc (NASDAQ: ENDP) is a highly focused generics and specialty branded pharmaceutical company delivering quality medicines to patients in need through excellence in development, manufacturing and commercialization. Endo has global headquarters in Dublin, Ireland, and U.S. headquarters in Malvern, PA. Learn more at www.endo.com.
The incumbent has primary responsibility for regulatory review and approval of prescription drug related communications. This includes advertising and promotion materials, scientific publications and medical education communications for assigned product(s). Collaborates with all review team members during development of marketing campaigns or other types of product communication to provide comprehensive regulatory compliance guidance. Serves as the regulatory liaison to FDA’s Office of Prescription Drug Promotion (OPDP) and is responsible for making regulatory submissions and responding to communications with the agency. Takes on a leadership role to: continuously improve review processes; partners with Endo’s corporate compliance to fulfill compliance requirements; develops and delivers regulatory training presentations and leads regulatory and R&D initiatives to optimize culture of inclusiveness and collaboration. The incumbent will monitor Office of Prescription Drug Promotion (OPDP) activities and actions, assesses impact, and communicate that information on an on-going, company-wide basis. Proactively contributes to identifying and implementing strategic approaches to reduce regulatory enforcement. Operates with independence and builds relationships with key stakeholders to maintain customer focus.
No supervisory or budget management responsibilities other than prudent use of company resources in accomplishing assigned responsibilities and individual objectives.
ROLE AND RESPONSIBILITIES:
- Works independently as the primary Regulatory Reviewer in the Marketing Advertising Review Committees (MARC) Process and the Non Promotional Review Committee (NPRC) Process for assigned product(s). Participates in the management of the MARC and NPRC processes, ensuring that review activities are conducted consistent with corporate Policy.
- Provides leadership, advice, and direction regarding application of FDA OPDP regulations and guidance as well as other industry norms and Endo corporate policies associated with prescription drug communications.
- Develops and leads in the delivery of regulatory compliance training to company staff and third party vendors.
- Helps conduct regulatory training on commercial booths during pre-convention meetings for Endo sales representatives and marketing personnel; monitors competitive promotional and marketing activities for assigned product(s).
- Collaborates with Marketing Services, Marketing, Regulatory Affairs, Medical Affairs, and Legal to help maintain compliance and update process documents. Collaborates with the Regulatory Affairs Labeling Group to communicate any labeling updates to Marketing/Marketing Services/Medical Information groups and various stakeholders in the company. Provides direction and implementation plans for changes in affected materials. Participates on cross-functional teams for developing content for draft package inserts for NDA submissions.
- Serves as the primary Company contact with the FDA Office of Prescription Drug Promotion. Manages the submission of promotional items to OPDP on Form FDA 2253 . Manages OPDP correspondence history for assigned product(s). Leads the preparation for meetings conducted with OPDP, including rehearsals and development of internal briefing material for key attendees as needed. Prepares and ensures quality of OPDP advisory comment submissions (i.e., core launch materials) for assigned product(s).
- Ensures timely communication of OPDP advisory comments received to respective review teams and internal stakeholders within the company. Monitors the OPDP web site and other resources for untitled letters and warning letters and summarizes these letters in a monthly update communication to various stake holders within the company (marketing, marketing services, regulatory, senior leadership, etc).
- BS in life sciences required; advanced degree preferred (MS, PharmD or JD).
- Minimum of 8-10 years of Pharmaceutical experience including a minimum of 6 years of experience conducting regulatory review or managing review of advertising and promotion material.
- Demonstrated understanding of regulatory issues and requirements; knowledge of advertising and promotion regulations, guidances, agency regulatory action history and product labeling requirements.
- Working knowledge of FDA labeling and advertising regulations/guidance and related regulatory and legal aspects of drug product promotion.
- Strong knowledge of the nature of marketing and sales disciplines within the pharmaceutical industry.
- Knowledge of the processes of development, production and distribution of communications through various media (e.g. print, internet, broadcast, etc.).
- Customer focus, Ethics and Values, Functional/Technical Skills, Interpersonal Savvy, Peer Relationships, Process Management, Conflict Management, Learning on the Fly, Integrity and Trust.
- Project management skills and experience: ability to present recommendations, sequence work, identify cross-functional needs, drive to completion, provide reports and evaluate results.
- Strong, professional interpersonal skills including ability to communicate effectively with people individually and groups; experience establishing and maintaining effective relationships with external partners; ability to manage stressful situations.
- Excellent presentation skills including ability to tailor information and delivery to audience; manage pace, timing and audience engagement; field and respond to questions; adjust approach and content to last minute changes; present in various formats (slides, video, speaking) and delivery methods (teleconference, video conference, web cast, panel, platform, office demonstration).
- Effective negotiation skills especially involving regulatory authorities.
- Editorial skills and ability; experience developing and managing technical processes and procedures.
- Dealing with Ambiguity, Decision Quality. Use sound judgment to solve problems and challenge the status quo.
Business Travel - approximately 5%.
Endo recognizes the advantages of a diverse workforce achieved through a commitment to equal employment opportunities.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled