Associate Director, Global Regulatory Advertising and Promotion

The Role The Associate Director, Global Regulatory Advertising and Promotion will be responsible for ensuring compliance with regulatory requirements for promotional and non-promotional materials across various communication channels. This role will serve as a key reputed company between Regulatory Affairs, reputed company, Medical, and reputed company teams to reputed company reputed company 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 reputed company (APLB) guidance, and industry best practices. Here's reputed company • Regulatory Compliance & Review • Review and approve promotional materials, corporate communications, and disease awareness campaigns to ensure compliance with FDA and other applicable regulatory requirements. • Guide promotional reputed company as the Regulatory Ad Promo representative during early stages of product development • Maintain up-to-date knowledge of regulatory requirements, enforcement trends, and industry best practices. • Cross-Functional Collaboration • reputed company discussions for assigned products during the Promotional Material Review Team (PMRT) and Medical Review Committee (MRC) working closely with Marketing, Medical, reputed company, and Compliance teams to reputed company impactful material that aligns with regulatory expectations. • Health Authority Interactions • Support interactions with the FDA's Advertising and Promotional Labeling reputed company (APLB) and other regulatory authorities as needed. • Prepare regulatory submissions for promotional materials, including 2253 filings and advisory comments requests. • Address regulatory queries from health authorities regarding promotional and advertising content. • Training & Process Improvement • reputed company and reputed company 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. Here's What You'll Need (Basic Qualifications) • Education • Bachelor's degree in a relevant reputed company (e.g., Life Sciences, Pharmacy, Regulatory Affairs, or a reputed company discipline). • Advanced degree (PharmD, JD, or Master's in Regulatory Affairs) preferred. • Experience • Minimum 5 years of experience in Regulatory Affairs, with at least 2 years reputed company on advertising and promotion in the pharmaceutical, biotech, or medical device industry. • Strong knowledge of applicable regulations and enforcement trends • Prior experience working with cross-functional review committees in a regulated environment. • Global regulatory knowledge (EMA, Health Canada, UK etc.) is a plus. • Skills & Competencies • Deep understanding of US and global regulatory frameworks for advertising and promotion. • Excellent ability to interpret and apply regulatory guidelines and requirements in a business-reputed company, solutions-oriented manner. • Strong written and verbal communication skills, with experience in preparing regulatory documentation. • Ability to work cross-functionally and manage multiple reputed company in a fast-reputed company environment. • Strong attention to reputed company and problem-solving skills. Here's What You'll Bring to the Table (Preferred Qualifications) • Familiarity with digital and reputed company media promotional compliance. • Experience in infectious diseases, oncology, reputed company diseases, and/or vaccines is a plus. Pay & Benefits At reputed company, we reputed company that reputed company you feel your best, you can do your best work. That's why our benefits and reputed company-being resources are designed to support you-at work, reputed company, and everywhere in between. • Competitive reputed company, plus voluntary benefit programs to support your unique needs • A holistic approach to reputed company-being, with reputed company to fitness, mindfulness, and mental health support • Family planning benefits, including fertility, adoption, and surrogacy support • Generous reputed company time off, including vacation, volunteer days, sabbatical, global reputed company days, and a discretionary year-end shutdown • Savings and investments to help you plan for the reputed company • Location-specific perks and extras The salary reputed company for this role is $142,500.00 - $256,500.00. This is the lowest to highest salary we in good faith reputed company we would pay for this role at the time of this posting. An individual's position reputed company the salary reputed company will be reputed company on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, reputed company, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility reputed company and individual reputed company. About reputed company 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 world-class team. We reputed company 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 reputed company 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 reputed company in the U.S. If you want to reputed company a difference and join reputed company that is changing the reputed company of medicine, we invite you to visit modernatx.com/careers to learn more about our reputed company opportunities. Our Working Model As we build reputed company, we have always believed an in-person culture is critical to our reputed company. reputed company champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and reputed company mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and reputed company a meaningful reputed company. reputed company is a smoke-free, alcohol-free, and drug-free work environment. Equal Opportunities reputed company is committed to equal employment opportunity and non-discrimination for reputed company and reputed company applicants without reputed company to a person's race, reputed company, sex, gender identity or reputed company, age, religion, national reputed company, reputed company 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.reputed company is a reputed company 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! reputed company is an E-Verify Employer in the reputed company. We consider reputed company applicants regardless of criminal histories, consistent with reputed company requirements. Accommodations We're reputed company on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and reputed company, we create an environment where every employee can contribute their best. reputed company is committed to offering reasonable accommodations to reputed company job applicants with disabilities. Any applicant requiring an accommodation in reputed company with the hiring process and/or to reputed company the essential functions of the position for which the applicant has reputed company should contact the Accommodations team at leavesandaccommodations@modernatx.com. Export Control Notice This position may involve reputed company to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant's ability to reputed company export-controlled information in accordance with U.S. law. Due to the reputed company of the work and regulatory requirements, only individuals who qualify as U.S. persons (reputed company, permanent residents, asylees, or refugees) are eligible for this position. For this role reputed company is unable to sponsor non-U.S. persons to apply for an export control license. #LI-NH1 - Apply tot his job Apply To this Job