17 days old

Regulatory Affairs Director, Advertising & Promotional Review

GE Energy
Marlborough, MA 01752
Role Summary: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

Qualifications/Requirements: 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

About Us:With 4000+ employees serving 100+ countries, GE Healthcares Pharmaceutical Diagnostics (PDx) business is the number one global supplier of contrast media and molecular imaging agents used in medical imaging exams to improve the visibility of organs, blood vessels or tissues, often helping radiologists distinguish between normal and abnormal conditions. PDx products makes a huge impact worldwide - supporting three patients every second.

GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, gender (including pregnancy), sexual orientation, gender identity or expression, age, disability, veteran status or any other characteristics protected by law.

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.Additional Locations:United States;Alabama, Alaska, American Samoa, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Guam, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Northern Mariana Islands, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, United States Minor Outlying Islands, Utah, Vermont, Virgin Islands, U.S., Virginia, Washington, West Virginia, Wisconsin, Wyoming;Marlborough, MA; Arlington Heights, IL; or field based;

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Posted: 2020-06-19 Expires: 2020-07-19

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Regulatory Affairs Director, Advertising & Promotional Review

GE Energy
Marlborough, MA 01752

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