Biolife Plasma Services
Associate Director, US Advertising & Promotion Regulatory Review
Massachusetts - Virtual · Director · Full-time
Sponsorship not specified$154k-$243kDetected 10 hours ago
ComplianceNegotiationPerformance ManagementFDA RegulatoryLeadershipMentoringRegulatory Affairs
About the role
- Join Takeda as an Associate Director, US Advertising & Promotion Regulatory Review where you will be working on the US Medical team.
- In this role, you will be empowered to serve as an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products.
- You will contribute to Takeda's mission by providing regulatory strategic oversight for complex products or therapeutic area products to help ensure regulatory compliance of promotional materials generated for assigned US products and/or compounds.
Responsibilities
- Mentor and develop staff.
- At Takeda, you will make an impact on people's lives - including your own.
Requirements
- Bachelor's Degree in life science or equivalent required.
- You will have a minimum of 5 years' experience in drug, biologic and/or device Regulatory Affairs or related field, including a minimum of 3 years' experience specific to Regulatory Affairs - Advertising and Promotion.
- Experience in Regulatory Affairs promotion and advertising
- experience managing major regulatory filing(s) (e.g., launch advisory comment submission or responses to enforcement letters) or competitor complaints.
Nice to have
- Advanced degree (PharmD, PhD, MS, MBA, JD) preferred.
Compensation
- $154,400.00 - $242,550.00 The estimated salary range reflects an anticipated range for this position.
- The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
Benefits
- Collaborate with Regulatory Affairs, Medical, Legal, Commercial, and Compliance, execute and approve key Commercial campaigns.
- U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
Equal opportunity
- Takeda is an equal opportunity employer.
- For applicants of U.S and Puerto Rico positions: Click here to learn about our commitment to Equal Employment Opportunity (EEO).
- If you are limited in the ability to use our job application tool, or otherwise require a reasonable accommodation for a disability please click here.
Visa & Work Authorization
- ligion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era
Apply directly at Biolife Plasma Services →Create a free account for alerts like thisView Biolife Plasma Services immigration profile
This listing is sourced directly from Biolife Plasma Services's careers page and normalized into a canonical job model.