Senior Manager Global Regulatory Advertising Promotion
Senior Manager Global Regulatory Advertising Promotion
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1 Vacancy
Job Description
The Role
The Senior Manager Global Regulatory Advertising and Promotion will be responsible for ensuring compliance with regulatory requirements for promotional and nonpromotional materials across various communication channels. This role will serve as a key liaison between Regulatory Affairs Legal Medical and Commercial teams to provide strategic regulatory guidance on advertising and promotional activities. The ideal candidate will have expertise in FDA regulations OPDP (Office of Prescription Drug Promotion)/Advertising and Promotional Labeling Branch (APLB) guidance and industry best practices.
Heres What Youll Do
- Review and approve promotional materials corporate communications and disease awareness campaigns to ensure compliance with FDA and other applicable regulatory requirements.
- Help provide guidance on promotional considerations during early stages of product development
- Maintain uptodate knowledge of regulatory requirements enforcement trends and industry best practices.
- Act as a key member of the Promotional Material Review Team (PMRT) and Medical Review Committee (MRC) working closely with Marketing Medical Legal and Compliance teams to develop impactful material that aligns with regulatory expectations.
- Support interactions with the FDAs Advertising and Promotional Labeling Branch (APLB) and other regulatory authorities as needed.
- Assist in preparing regulatory submissions for promotional materials including 2253 filings and advisory comments requests.
- Address regulatory queries from health authorities regarding promotional and advertising content.
- Develop and deliver training programs on promotional regulations for internal stakeholders.
- Help refine internal SOPs best practices and review processes for advertising and promotion compliance.
- Monitor and analyze enforcement actions and industry trends to proactively mitigate regulatory risks.
Heres What Youll Need (Basic Qualifications)
- Bachelors degree in a relevant field (e.g. Life Sciences Pharmacy Regulatory Affairs or a related discipline).
- Advanced degree (PharmD JD or Masters in Regulatory Affairs) preferred.
- Minimum 24 years of experience in Regulatory Affairs with at least 2 years focused on advertising and promotion in the pharmaceutical biotech or medical device industry.
- Strong knowledge of applicable regulations and enforcement trends
- Prior experience working with crossfunctional review committees in a regulated environment.
- Global regulatory knowledge (EMA Health Canada etc. is a plus.
- Deep understanding of US and global regulatory frameworks for advertising and promotion.
- Excellent ability to interpret and apply regulatory guidelines and requirements in a businessfocused solutionsoriented manner.
- Strong written and verbal communication skills with experience in preparing regulatory documentation.
- Ability to work crossfunctionally and manage multiple projects in a fastpaced environment.
- Strong attention to detail and problemsolving skills.
Heres What Youll Bring to the Table (Preferred Qualifications)
Familiarity with digital and social media promotional compliance.
Experience in infectious diseases oncology rare diseases and/or vaccines is a plus.
A desire to make an impact as part of a highgrowth transformational company that is Bold Relentless Curious and Collaborative.
At Moderna we believe that when you feel your best you can do your best work. Thats why our US benefits and global wellbeing resources are designed to support youat work at home and everywhere in between.
- Bestinclass healthcare coverage plus a suite of voluntary benefit programs to support your unique needs
- A holistic approach to wellbeing with access to fitness mindfulness and mental health support
- Lifestyle Spending Accounts to personalize your wellbeing journey
- Family planning and adoption benefits
- Generous paid time off including vacation volunteer days sabbatical global recharge days and a discretionary yearend shutdown
- Savings and investment opportunities
- Locationspecific perks and extras
About Moderna
Since our founding in 2010 we have aspired to build the leading mRNA technology platform the infrastructure to reimagine how medicines are created and delivered and a worldclass team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission values and mindsets every day our people are the driving force behind our scientific progress and our culture. Together we are creating a culture of belonging and building an organization that cares deeply for our patients our employees the environment and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer a Fast Company Best Workplace for Innovators and a Great Place to Work in the U.S.
As we build our company we have always believed an inperson culture is critical to our success. Moderna champions the significant benefits of inoffice collaboration by embracing a 70/30 work model. This 70 inoffice structure helps to foster a culture rich in innovation teamwork and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn contribute and make a meaningful impact.
If you want to make a difference and join a team that is changing the future of medicine we invite you to visit modernatx/careers to learn more about our current opportunities.
Moderna is a smokefree alcoholfree and drugfree work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day please apply!
Moderna is committed to equal employment opportunity and nondiscrimination for all employees and qualified applicants without regard to a persons race color sex gender identity or expression age religion national origin ancestry or citizenship ethnicity disability military or protected veteran status genetic information sexual orientation marital or familial status or any other personal characteristic protected under applicable law.
Moderna is an EVerify Employer in the United States. We consider qualified applicants regardless of criminal histories consistent with legal requirements.
Were focused on attracting retaining developing and advancing our employees. By cultivating a workplace that values diverse experiences backgrounds and ideas we create an environment where every employee can contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at . (EEO Employer)
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Exec
Employment Type
Full-Time
