Regulatory Affairs Sr Manager, Regulatory… at Jobgether · Remote

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Regulatory Affairs Senior Manager, Regulatory Promotion & Material Compliance based in the United States.

This role is a strategic regulatory leadership position focused on ensuring that promotional and scientific communications for pharmaceutical products meet strict FDA requirements and remain accurate, balanced, and compliant. You will serve as a key authority in interpreting evolving regulatory guidance and translating it into clear, actionable standards for promotional review activities across products and disease areas. Acting as a trusted advisor within a highly collaborative environment, you will help shape compliant communication strategies that support both marketed and pipeline therapies. The role involves reviewing promotional materials, guiding cross-functional stakeholders, and ensuring alignment with regulatory expectations in a fast-paced biotech setting. You will also mentor junior reviewers and contribute to strengthening internal regulatory capabilities. This is a high-impact role suited for a detail-oriented regulatory expert who thrives at the intersection of science, compliance, and strategic communication.

Accountabilities:

• Provide strategic regulatory guidance for promotional and disease-related communications, ensuring compliance with FDA requirements and internal standards.
  • Review and evaluate promotional materials through promotional review committees, assessing scientific accuracy, supporting evidence, and compliance alignment.
  • Interpret evolving regulatory guidance and enforcement trends to assess business and product impact.
  • Define and communicate regulatory promotional positions for approved and pipeline products.
  • Identify required changes to promotional content to ensure adherence to regulatory standards.
  • Monitor external regulatory developments, congress insights, and industry trends and share key learnings with internal teams.
  • Mentor and support development of associate and manager-level regulatory reviewers.
  • Collaborate cross-functionally with clinical, commercial, and legal teams to ensure compliant messaging across all materials.
  • Provide expert judgment on data interpretation and its appropriate application in promotional contexts.

Requirements:

    - Advanced degree in life sciences, pharmacy, medicine, or related field with significant regulatory experience (Bachelor’s + 6 years, Master’s + 4 years, or equivalent experience).
    - Strong expertise in FDA promotional regulations and experience applying them in a dynamic pharmaceutical or biotech environment.
    - Proven experience in promotional review committees and regulatory review of commercial or scientific materials.
    - Strong analytical and critical thinking skills with the ability to interpret complex scientific and regulatory information.
    - Excellent communication, negotiation, and stakeholder management skills across cross-functional teams.
    - Demonstrated ability to influence decisions and provide regulatory leadership in a matrix environment.
    - Experience mentoring or coaching junior regulatory professionals.
    - Strong organizational, project management, and time management skills.
    - Ability to work independently while exercising sound judgment in high-stakes compliance decisions.

Benefits:

        - Competitive annual salary range: $142,579 – $192,901 USD.
        - Comprehensive healthcare coverage including medical, dental, and vision insurance.
        - Retirement and savings plan with employer contributions.
        - Annual bonus eligibility and long-term stock-based incentives.
        - Flexible work arrangements where applicable.
        - Generous paid time off and flexible time-off programs.
        - Life, disability, and supplemental insurance coverage.
        - Health savings and flexible spending account options.
        - Strong focus on career development, mentorship, and internal growth opportunities.
        - Inclusive, science-driven culture focused on innovation and patient impact.

How Jobgether works:

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

Why Apply Through Jobgether?

Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.

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