Senior Regulatory Affairs Consultant Advertising and Promotion

Raleigh, WV - USA

Monthly Salary: Not Disclosed

Posted on: 20 hours ago

Vacancies: 1 Vacancy

Job Summary

When our values align theres no limit to what we can achieve.

At Parexel we all share the same goal - to improve the worlds health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us no matter what we do at Parexel contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally we do it with empathy and were committed to making a difference.

We are seeking a motivated Senior / Regulatory Affairs Consultant Advertising & Promotion to join Parexel and work as a trusted partner within a major client this role you will partner with cross-functional teams to ensure that all promotional marketing educational and social media materials comply with US regulatory requirements. Youll play a key role in supporting product launches campaigns and ongoing promotional activities while safeguarding compliance and patient trust.

Key Responsibilities

Review and approve advertising and promotional materials including direct-to-consumer campaigns medical education and social media content.

Provide regulatory guidance to cross-functional teams (Marketing Medical Affairs Legal) during promotional material development.

Participate in promotional review committees ensuring alignment with FDA regulations and company standards.

Collaborate with global teams to ensure consistency across markets while meeting US-specific requirements.

Maintain compliance with FDA 21 CFR Part 202 and other relevant US regulations.

Support preparation of responses to regulatory inquiries related to promotional activities.

Track and manage promotional submissions and approvals in regulatory systems

Manage SOPs and electronic review systems.

Qualifications

Education: Bachelors degree in Life Sciences Pharmacy Regulatory Affairs or related field.

Experience:

35 years of pharmaceutical/biotech related industry experience.

Direct experience in advertising and promotional regulatory review.

Familiarity with FDA regulations governing promotional materials.

Skills:

Strong organizational skills with the ability to manage multiple projects under tight timelines.

Excellent communication skills with the ability to explain regulatory concepts including FDA regulations/guidances clearly to cross-functional partners.

Attention to detail combined with strategic thinking.

Proficiency with Microsoft Office and regulatory systems (e.g. Veeva PromoMats eDMS).

Ability to create and revise Ad/Promo SOPs to ensure promotional materials are updated as required by FDA regulations and company standards.

Competencies:

Knowledge of US regulatory requirements for advertising and promotion.

Demonstrated problem-solving ability and sound decision-making.

Ability to work effectively in a matrix environment and collaborate across diverse teams.

Strong interpersonal skills with cross-cultural awareness.

Fluency in English (verbal and written).

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EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status which in the US includes race color religion sex sexual orientation gender identity national origin disability or protected veteran status.

Required Experience:

Senior IC

When our values align theres no limit to what we can achieve.At Parexel we all share the same goal - to improve the worlds health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something special - a deep conviction in...