Regulatory Affairs Specialist generating regulatory submissions and managing compliance for medical device engineering projects at Teleflex. Ensuring adherence to FDA and Health Canada regulations with effective project timelines.
About the role
- Director of US Regulatory Affairs at Sanofi ensuring compliance in advertising and promotion materials. Collaborating with teams to shape the future of medicine through regulatory strategies.
Responsibilities
- Ensure materials are consistent with US regulations, company policy and industry guidelines
- Solve problems creatively and strategically, introducing innovative concepts
- Participate in a more strategic capacity in the functional area and day-to-day decision-making process
- Monitor the regulatory environment and interpret new regulations
Requirements
- Earned Bachelor’s degree from an accredited four-year college or university in a Life Sciences or other relevant discipline
- 8+ years of experience within pharmaceutical or medical device Regulatory Affairs, with 5+ years specifically within advertising & promotion functions
- Leadership, mentoring and/or training experience within regulatory or ad/promo is highly preferred
- Extensive knowledge and understanding of complex medical and scientific subject matter, including statistical data
- Ability to generate innovative solutions in work situations
Benefits
- high-quality healthcare
- prevention and wellness programs
- at least 14 weeks’ gender-neutral parental leave
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