Director of Regulatory Affairs - Pharmaceutical
Ironwood Pharmaceuticals - Cambridge, MA

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The Director of Regulatory Affairs - Advertising and Promotion will be responsible for leading the regulatory review and approval of promotional materials and marketing activities. The successful candidate will provide regulatory guidance to ensure Ironwood implements product advertising and marketing programs that comply with applicable laws, rules and regulations, the company?s code of conduct and policies, and consistent with good science. The Director will also deliver training to appropriate company personnel on issues such as compliance with promotional regulatory requirements and exchange of scientific information. This position will report to the Vice President, Regulatory Affairs.

- Provide regulatory direction and risk evaluation to support the creation of compliant and effective promotional materials, such as marketing materials, professional and consumer informational and educational materials, institutional promotional materials, disease awareness, press releases, websites, and speaker presentations;
- Review and if appropriate, approval of product advertising and promotional materials;
- Coordinate with Medical Scientific Affairs and Corporate Communications to ensure communications and information developed by those departments comply with applicable laws and regulations, best industry practices, and Ironwood?s policies/code of conduct;
- Provides regulatory training to on-site personnel, field colleagues and speakers/vendors regarding compliance with FDA regulations and guidelines as well company policies;
- Develop Regulatory Affairs policies and procedures for review and approval of product promotional material;
- Monitor U.S. regulatory climate by reviewing OPDP letters and regulatory guidelines, and provide guidance and direction to the company on changes in this area;
- Maintain working knowledge of Ironwood?s products;
- Provide effective and appropriate recommendations for Phase 4 clinical trial design with regard to promotability of potential data/claims.

- Bachelors or advanced degree in a scientific discipline; advanced (including Pharm D.) degree preferred;
- A minimum of 12 years of increasingly-responsible regulatory experience in the pharmaceutical industry, including experience in promotional regulatory affairs;
- Work well with external business partners and Ironwood employees across the entire organization;
- Deep and broad knowledge of regulatory affairs and compliance; direct experience with regulatory aspects of prescription drug marketing, including review of advertising and promotional materials as well as scientific exchange information (such as abstracts and journal articles);
- A proven track record of effective collaboration with regulatory agencies, including OPDP;
- Knowledge and understanding of FDAMA 114, ACCME Guidelines, AMA Guidelines, PhRMA Code on Interactions with Healthcare Professionals, and AAMC Guidelines, along with solid understanding of anti-kick back (Fraud and Abuse) Statutes, and False Claims Act;
- Excellent verbal and written communication skills and collaborative interpersonal skills;
- Analytical and interpretative skills, enabling review and synthesis of reports and other documents used in promotional regulatory strategy and submissions;
- Some travel required.


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About this company
Ironwood Pharmaceuticals takes an iron fist to gastrointestinal ailments and other medical conditions. The company develops internally...