Director, Regulatory Affairs, Promotion and Advertising-1300165 Description OBJECTIVE: ACCOUNTABILITIES: - Oversees regulatory guidance provided to ensure compliance with promotional regulations.
- Oversight/Accountable for all submissions within group. Approve enforcement responses.
- Manages personnel within group to ensure coverage for brand and therapeutic area responsibilities.
- Understand and interpret complex scientific issues as it relates to regulatory requirements and promotional strategy. Able to mentor and develop skills of staff.
- Understands broad concepts within regulatory affairs and implications across organization. Proactively identifies regulatory issues. Offers creative solutions and strategies, including risk mitigation strategies.
- Develops strategy for efficient and appropriate OPDP review and play a key role in life cycle management strategy such that scientific, regulatory and commercial plans are aligned for all areas of responsibility.
- Identifies trends in Agency enforcement, policies and procedures; incorporates into regulatory decisions and strategy; responsible for establishing and maintaining a process for sharing enforcement trends etc, with appropriate TPUSA employees.
- Reviews competitive materials and interacts with FDA to urge enforcement activity as necessary.
- Develop department area by ensuring structure; organization and functional processes are aligned by ensuring compliance and defining SOPs and training of business partners.
- Works closely with Medical, Legal, OEC, Marketing, Marketing Operations, Sales, and Sales Training departments as well as external advertising agencies and consultants in the successful development of promotional and applicable training materials. Works to align promotional goals with the goals of the cross-functional MRL team.
- Support development and maintenance of product labeling with Regulatory Affairs Labeling and Strategy groups. Support regulatory direction and review for pre and post launch regulatory strategies (which may include label (PI), protocols, SNDA's, etc)
- Lead for Promotion and Advertising Regulatory Review for licensing opportunities
- Other duties as assigned or needed
Qualifications EDUCATION, EXPERIENCE AND SKILLS: - BS/BSc. Advanced scientific related degree or PharmD preferred.
- > 10 years industry; inclusive of > 8 years regulatory or related experience
- Experience in managing multiple filings e.g. Launch Advisory Materials or responses to enforcement letters. Promotion and Advertising experience in multiple therapeutic areas
- Prior people management required; multiple personnel for > 5 years preferred
- Generally strong in working well within Regulatory, cross-functionally and communicating /negotiating with senior leadership.
- Must be strong in strategic and problem solving skills over all with an ability to identify the critical issues of problems or opportunities using appropriate information and judge risk based on FDA trends; determines the causes and possible solutions to the problem.
- Must be strong leader that creates vision for the group. Inspires and motivates group. Takes stand on important issues in productive, respectful way. Must have demonstrated outstanding judgment.
- Ability to express one's self clearly and concisely; documents issues and/or concerns concisely and comprehensively; adjusts language and/or terminology appropriate to the audience; ability to communicate effectively with business partners and company management to enhance efficient, timely and balanced decision making. Must be especially strong in negotiation skills and integrity. Works well with others, especially on a cross-functional team. Demonstrated ability to effectively manage and bring together working teams together for common objectives. Presentation at industry meetings is desirable.
- Ability to capture knowledge and share within the organization; improves solutions, processes, and deliverables through use of information; improves information capital by contributing experience, theories, deliverables and models for others to use
- Ability to assist in the development of an operating budget to monitor and control expenditures.
- Understands the phases, processes and techniques used within a clinical development environment, can contribute to clinical study design discussions as needed.
- Understand FDA regulations relative to advertising and promotion, for health professional and consumer audiences. Experience in managing multiple filings e.g. Launch Advisory Materials or responses to enforcement or proactive complaints to OPDP about competitors.
- Understands the pharmaceutical industry and has experience in evaluating promotion and advertising materials in multiple therapeutic areas.
- Understands medical/therapeutic impact of products; understanding of potential product applications, and competitive products.
- Understands Takeda's operating structure and methods including a thorough knowledge of the foreign-owned parent company.
- Maintains a current knowledge of applicable government regulations, particularly those related to advertising and promotion. Has a thorough knowledge of historical enforcement actions and is readily able to use this in negotiation.
PHYSICAL DEMANDS - The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Ability to drive or fly to various meetings/ client sites - limited overnight. Some international travel may be required.
- The work environment characteristics described here are representative of those an employee encounters while performing the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Due to travel, the work environment includes exposure to both inside and outside working conditions. Temperature and length of exposure varies depending upon meeting location and transportation. 15-20% travel required.
We are driven to improve people's lives. We are an equal opportunity employer. No Phone Calls or Recruiters Please. Job Research and Development Primary LocationIL-Home Office (Deerfield) Schedule Full-time Education Level Bachelor's Degree Status (1) Regular | |
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