Associate Director, CMC Regulatory Affairs, International at Moderna

London, England, United Kingdom -

Full Time

Start Date

Immediate

Expiry Date

31 Aug, 26

Salary

0.0

Posted On

02 Jun, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

CMC Regulatory Strategy, International Submissions, Regulatory Compliance, CTD Format, Biologics, EU Regulations, ROW Regulations, CGMP, Agency Correspondence, Change Control Evaluation, Technical Writing, Project Management

Industry

Biotechnology Research

Description

The Role Moderna is looking for a Associate Director, CMC Regulatory Affairs-International, to join our team based in London, UK. This pivotal role will focus on preparing and overseeing CMC and Quality related agency correspondence and regulatory applications, governing CMC submissions, and providing regulatory compliance support for the development of global products. The successful candidate will lead and support all regulatory activities, ensuring the delivery of high-quality CMC sections of regulatory documentation. This role demands a dynamic individual capable of managing multiple projects in a fast and results-oriented environment, dedicated to bringing a new generation of transformative medicines to patients. Here’s What You’ll Do Developing and implementing effective CMC regulatory strategies for international submissions (e.g., IND/CTA/BLA/MAA) and identifying regulatory risks. Providing guidance on regulatory CMC aspects of product development projects. Reviewing documents for submission readiness, ensuring conformity to health authority guidelines. Leading Regulatory CMC discussions and interactions with health authorities to facilitate the review and approval of submissions. Developing regulatory processes and procedures to support the CMC components of regulatory submissions. Your responsibilities will also include Supporting the creation and maintenance of CMC submission templates. Providing CMC regulatory guidance to manufacturing and quality teams; evaluating CMC change controls. Offering interpretations of regulatory guidance documents, regulations, and directives, advising on their applicability and impact on internal programs. Leading oversight of multiple programs in various therapeutic areas (vaccines, oncology, and/or rare diseases). The key Moderna Mindsets you’ll need to succeed in the role Pursue options in parallel: This role requires a strategic thinker who can explore multiple avenues simultaneously to ensure the most efficient and effective regulatory strategies. Act with urgency: Given the fast-paced and result-oriented environment, acting swiftly and decisively is crucial to meet deadlines and deliver transformative medicines to patients. Here’s What You’ll Need (Basic Qualifications) BS in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is required. MS degree in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is desirable 10+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus 8+ years of experience in Biologics focused Regulatory CMC Multidisciplinary focus on certain therapeutic areas (vaccines, oncology and/or rare diseases) Strong knowledge of current EU and ROW regulations Strong knowledge of Cgmp Strong experience with CTD format and content regulatory filings Exceptional written and oral communication Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work. That’s why our global benefits and well-being resources are designed to support you—at work, at home, and everywhere in between. Best-in-class healthcare, plus voluntary benefit programs to support your unique needs A holistic approach to well-being with access to fitness, mindfulness, and mental health support Family building benefits, including fertility, adoption, and surrogacy support Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown Savings and investments to help you plan for the future Location-specific perks and extras The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work. 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 world-class 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 in-person culture is critical to our success. Moderna 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 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.com/careers to learn more about our current opportunities. Moderna is a smoke-free, alcohol-free, and drug-free 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 opportunity in employment and non-discrimination for all employees and qualified applicants without regard to a person's 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. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. We’re 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 accommodation or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment 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 and Adjustments team at leavesandaccommodations@modernatx.com. - Our Mission and Vision At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission. Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients. Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today. Third Party Staffing Agencies Moderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes. Reasonable Accommodation Notice Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing humanresources@modernatx.com if you need assistance completing any forms or to otherwise participate in the application process. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment. Return Home

Responsibilities

Lead the preparation and oversight of CMC and Quality regulatory applications and agency correspondence for international markets. Develop regulatory strategies and provide guidance to manufacturing and quality teams to ensure compliance and product approval.