Sobi
Head of Global Regulatory Advertising and Promotion
Waltham, MA, United States
Sponsorship not specified$260k-$290kDetected 56 days ago
Data EngineeringStatisticsFDA RegulatoryResearchLeadershipCommunicationCollaboration
About the role
- Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications.
- Sobi encourages you to change that statistic and apply.
- Rarely do candidates meet 100% of the qualifications.
Responsibilities
- Develops and leads departmental strategic initiatives
- Serve as strategic partner to internal leadership on regulatory risk assessment and mitigation
- Lead interactions with OPDP/APLB, including proactive engagement with OPDP/APLB in support of business needs, and as needed, response to regulatory inquiries.
- Lead development of SOPs and Work Instructions to drive compliance through streamlined workflows and efficient execution of relevant processes
- Apply advanced regulatory experience and business knowledge in the development of new ideas and best practices that support Sobi
- Demonstrate understanding of company objectives while executing regulatory strategies that deliver efficacious and FDA-compliant outcomes
- Demonstrates the ability to build agreement and acceptance through the ability to present a compelling case for ideas, negotiate persuasively, and address disagreements constructively
- A competitive 401(k) match to support your financial future.
Requirements
- Advanced understanding of FDA promotional regulations, industry trends, regulatory landscape, product and therapeutic knowledge as well as evidentiary standards required to support product claims
Nice to have
- Minimum of 15 years of experience in pharmaceutical industry and a minimum of 5 years as a regulatory Ad & Promo professional
- Experience in Rare Diseases, Hematology and/or Oncology a plus
Compensation
- $260k-$290k
Benefits
- Generous time off policy
- Provides vision, strategy and leads the adpromo team reporting into them
- Efficiently and systematically plan, prioritize, and execute individual work, team work, and projects while balancing quality, cost, risk, and benefits
This listing is sourced directly from Sobi's careers page and normalized into a canonical job model.