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Senior Manager, Commercial Regulatory - (Remote - US)

Jobgether has ALL remote jobs globally. We match you to roles where you're most likely to succeed, and provide feedback on every application to help you learn. No more guesswork, application black holes, or recruiter ghosting in your job search.

For one of our clients, we are looking for a Senior Manager, Commercial Regulatory, remotely from the United States.

In this role, you will be responsible for supporting labeling development and regulatory advertising and promotion efforts. Collaborating with cross-functional teams, you will ensure that labeling and promotional activities align with internal strategies and regulatory guidance. You will serve as a key member of the Commercial Regulatory Team, working closely with stakeholders to ensure compliance with global regulatory standards and contribute to key review committees. Your work will have a direct impact on the success of commercial programs by ensuring they meet all regulatory requirements.

Accountabilities:

  • Assist in the development of target product profiles, core data sheets, and regional labels.
  • Review and approve U.S. promotional materials for assigned assets, ensuring they meet regulatory guidelines.
  • Provide regulatory input on promotional concepts and draft materials to ensure alignment with business objectives and regulatory compliance.
  • Collaborate effectively with Regulatory Affairs counterparts and cross-functional teams to achieve program goals.
  • Maintain professional relationships with internal teams, external partners, regulatory experts, and health authorities.
  • Conduct regulatory intelligence research and maintain up-to-date knowledge of regulations.
  • Identify regulatory gaps and propose solutions to address challenges.

  • Bachelor’s degree in a related Life Sciences discipline; Master’s degree preferred.
  • Minimum 7+ years of experience in regulatory affairs, specifically in labeling, advertising, promotion, or drug development within the Biotech or Pharmaceutical industry.
  • Strong understanding of U.S. labeling requirements and the regulatory process for labeling changes.
  • Proven ability to analyze and understand the implications of label changes on pending and approved labels.
  • Experience in regulatory affairs with a strong focus on attention to detail and the ability to multitask in a dynamic, fast-paced environment.
  • Excellent written and verbal communication skills with a proven ability to collaborate across teams.
  • Premium health, financial, work-life, and well-being offerings for employees and dependents.
  • Wellness and employee support programs.
  • Life insurance, disability, and retirement plans with employer match.
  • Generous paid time off (PTO) and paid holidays.
  • Competitive base salary and short-term incentive programs.
  • Long-term incentive compensation, including company stock options.
  • A supportive and inclusive work environment committed to your growth and success.

#LI-CL1

Average salary estimate

$125000 / YEARLY (est.)
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$100000K
$150000K

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Inclusive & Diverse
Rise from Within
Mission Driven
Diversity of Opinions
Work/Life Harmony
Transparent & Candid
Growth & Learning
Fast-Paced
Collaboration over Competition
Take Risks
Friends Outside of Work
Passion for Exploration
Customer-Centric
Reward & Recognition
Feedback Forward
Rapid Growth
Medical Insurance
Paid Time-Off
Maternity Leave
Mental Health Resources
Equity
Paternity Leave
Fully Distributed
Flex-Friendly
Some Meals Provided
Snacks
Social Gatherings
Pet Friendly
Company Retreats
Dental Insurance
Life insurance
Health Savings Account (HSA)

Jobgether has the ambition to disrupt the recruitment industry as we know it by simplifying it and making it more accurate 🎯 Jobgether platform connects candidates and companies based on: - Skills -... Values - Ambition - Personality The candidat...

1004 jobs
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EMPLOYMENT TYPE
Full-time, remote
DATE POSTED
March 23, 2025

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