General Electric Regulatory Affairs Director, Advertising & Promotional Review in Marlborough, Massachusetts
We are the doers. The leaders. The makers. The change-bringers. We are all different, uniting to solve the world’s toughest challenges. Our teams are hungry to make history, acting with integrity to relentlessly improve people’s lives. With every weld, every sale, and every code we write we keep the world in motion. It’s time to stop dreaming about the future; let’s build it together.
This critical position provides direction to the business regarding regulatory activities required for the review and approval of promotional activities and marketing materials for all of our marketed drug products in the US & Canada. This position will provide input into the global organization for labeling strategies of marketed drugs. Individual in this position must demonstrate significant autonomy in carrying out assigned duties and responsibilities, including liaising with FDA as needed.
Essential Responsibilities :
• Directs and conducts regulatory reviews and approvals of promotional materials and marketing activities
• Ensures on-time and accurate submission of promotional materials to regulatory agencies
• Serves as internal regulatory expert on FDA regulations, guidance and enforcement trends governing the promotion of prescription drugs
• Provides regulatory leadership and expertise to the respective cross-functional teams that review promotional materials in compliance with applicable regulations and guidance
• Reviews and assesses proposed promotional materials to evaluate their completeness, accuracy and compliance with applicable regulations and procedures; reviewing and revising regulatory policies and procedures to ensure compliance with applicable regulations
• Serves as primary contact leading and facilitating communications with regulatory agency reviewers in the request and negotiation of advisory comments and any other interactions regarding use of promotional claims for assigned products, including pre-clearance of launch materials or materials requiring pre-clearance, as applicable
• Assists teams with the planning of proposed promotional materials and disease state materials
• Maintains a thorough understanding of the FDA Office of Prescription Drug Promotion (OPDP) requirements (and other regulatory agency related departments, as appropriate)
• Maintains up-to-date knowledge and understanding of current FDA and Health Canada regulatory and advertising and promotional compliance requirements
• Ensures the management and maintenance of records and databases that support communication with OPDP and record keeping of submissions and related materials
• Performs other duties as assigned
• Bachelor's Degree and 7 years’ experience in the pharmaceutical industry, with at least 3 years’ progressive experience in Regulatory Affairs promotional review
• Minimum of 2 years’ experience of regulatory project management and regulatory agency interactions
• Experience of working globally and across different cultures
• Demonstrated experience and proficiency with the Microsoft Office products (Word, Excel, PowerPoint, Access, Outlook)
• Strong written and verbal communication skills
Desired Characteristics :
• Experience in Zinc or Veeva software application is a plus
• Assertive and willing to make decisions
• Ability to assign clear priorities
• Ability to juggle multiple competing task and set clear priorities
• Organized and delivery focused
• Strong negotiation and decision-making skills
• Ability to make sound business judgments
• Ability to work independently in fast-paced environment with little supervision.
• Team-oriented and responsive to customer needs.
• Attention to Detail and Results-Oriented.
• Ability to understand technical documentation and execute associated procedures
Additional Eligibility Qualifications :
GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). This role is restricted to U.S. persons (i.e., U.S. citizens, permanent residents, and other protected individuals under the Immigration and Naturalization Act, 8 U.S.C. 1324b(a)(3)) due to access to export-controlled technology. GE will require proof of status prior to employment.
This role is restricted to U.S. persons (i.e., U.S. citizens, permanent residents, and other protected individuals under the Immigration and Naturalization Act, 8 U.S.C. 1324b(a)(3)) due to access to export-controlled technology. GE will require proof of status prior to employment.
GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer at http://www.ge.com/sites/default/files/15-000845%20EEO%20combined.pdf . at http://www.ge.com/sites/default/files/15-000845%20EEO%20combined.pdf Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
Relocation Assistance Provided: No