Senior Specialist, Regulatory Affairs

Job Description

The Senior Specialist is responsible for the review and approval of US promotional materials.

As a member of the Review Team, work collaboratively with legal, medical, and commercial colleagues to ensure that promotional practices are consistent with regulatory guidelines, our Company policies, and support business objectives

  

Under the direction of a Team Leader or Mentor: develop and implement effective strategies for FDA promotional submissions; manage the development of correspondence with FDA and the interpretation of FDA advisory comments. Conduct regulatory risk analysis and identify regulatory issues.

  

Maintain current awareness and understanding of FDA advisory correspondence, evolving FDA regulations and guidance documents, FDA enforcement letters and policy issues affecting the pharmaceutical/biologics industry. Communicate (written and verbal) basic regulatory positions.

  

Contribute to departmental or cross-functional initiatives to ensure effective and efficient promotional review practices.

Qualifications, Skills & Experience:

Minimum Requirement: 

• B.A. or B.S. degree with an emphasis in science, health care or related fields. 

Preferred:

• Master’s, PhD or PharmD degree with an emphasis in science, health care or related fields. 

• Minimum two years’ experience in pharmaceutical/biologics industry or related field, preferably in the regulatory, scientific, medical, legal or marketing disciplines.

• Basic understanding of FDA regulations relating to advertising and promotion for prescription products with a steadfast focus on quality & compliance.

• Fundamental understanding of the pharmaceutical industry drug development process, including labeling development.

• Understanding of the promotional content development and review processes. 

• Strong verbal and written communication skills. 

• Attention to detail and ability to manage multiple priorities simultaneously. 

• Strong interpersonal skills with ability to demonstrate strategic and analytical thinking. 

• Action oriented with strong cross-functional collaboration skills.

Required Skills:

Adverse Event Report, Biopharmaceuticals, Compliance Investigations, Cross-Functional Collaboration, Detail-Oriented, Drug Development, FDA Regulations, Labeling Compliance, Negotiation, Oral Communications, Pharmaceutical Development, Policy Implementation, Records Retention Management, Regulatory Communications, Regulatory Issues, Regulatory Risk, Regulatory Strategy Development, Regulatory Submissions, Risk Analysis, Technical Writing

Preferred Skills:

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Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encour