Manager, Regulatory Science, Cmc

Vor 2 Tagen

Basel, Schweiz Moderna Vollzeit

**The Role**:
**Here’s What You’ll Do**:

- Support effective CMC regulatory strategies for submissions (e.g. IND/CTA/BLA/MAA) and identify regulatory risks
- Provide guidance for regulatory CMC aspects of product development projects
- Review documents for submission-readiness, to ensure that all submissions conform to health authority guidelines
- Contribute in the Regulatory CMC discussions and interactions with health authorities to facilitate review and approval of submissions
- Support regulatory processes and procedures to support CMC components of regulatory submissions
- Support the creation and maintenance of CMC submission templates
- Provides CMC regulatory guidance to manufacturing and quality teams; evaluates CMC change controls
- Provides interpretation of regulatory guidance documents, regulations and directives - advises Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programs

**Here’s What You’ll Bring to the Table**:

- MS degree in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is desirable
- 6+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus
- 3+ years of experience in focused Regulatory CMC, preferably Biologics based
- Strong knowledge of current EU and International regulations related to the clinical, nonclinical, and CMC development
- Strong experience with CTD format and content regulatory filings
- Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance in the EU and International countries
- Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements
- Ability to work independently to manage multiple projects in a fast-paced environment
- Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment to drive meeting each program’s critical regulatory milestones
- Effectively communicate the regulatory strategy, risks, mitigations and overall plans to Project Teams and senior management, as relevant
- Outstanding communication skills (verbal and written) and willingness to share knowledge and lessons learned
- A desire to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative

**Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.**

We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:

- Quality healthcare and insurance benefits
- Lifestyle Spending Accounts to create your own pathway to well-being
- Free premium access to fitness, nutrition, and mindfulness classes
- Family planning and adoption benefits
- Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary winter break
- Educational resources
- Savings and investments
- 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**

In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
- Moderna is a smoke-free, alcohol-free and drug-free work environment._

  • Regulatory Affairs Cmc Associate Manager

    Vor 2 Tagen

    Basel, Schweiz SimplyVision GmbH Vollzeit

    For our customer located in Basel/Switzerland we are currently looking for a**:Regulatory Affairs CMC Associate Manager **(M/F/x)** - * pay rate range - given by our client: 51 chf/h* * Hiring Manager Job Description: * - As Associate Manager within our Global Regulatory Affairs CMC team, you support timely preparation of high quality CMC regulatory...

  • Regulatory Affairs Manager Cmc

    vor 2 Wochen

    Basel, Schweiz Coopers Group AG Vollzeit

    Regulatory Affairs Manager CMC For our client in Basel, we are looking for RA CMC Manager who will be responsible for global CMC submission activities for assigned projects. **Responsibilities**: - Identify the required documentation and any content, quality and/or timeliness issues for global submissions and negotiate the delivery of approved technical...

  • Associate Director, Global Regulatory Science

    vor 7 Monaten

    Basel, Schweiz Moderna Vollzeit

    **The Role**: Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners...

  • Sr. Director, Cmc Regulatory Science

    vor 2 Wochen

    Basel, Schweiz Moderna Therapeutics Vollzeit

    **The Role**: **Here’s What You’ll Do**: Lead a team to develop/implement effective CMC regulatory strategies for submissions (e.g. IND/CTA/BLA/MAA) and identify regulatory risks Provide expertise for regulatory CMC aspects of product development projects Review documents for submission-readiness, to ensure that all submissions conform to health...

  • Regulatory Affairs Manager/CMC LZAJP00004740

    Vor 5 Tagen

    Basel, Schweiz Coopers Group GmbH Vollzeit

    Duration: 30/10/2025, possible extensionKey Responsibilities:Manage timely responses to Health Authority (HA) questions (author/ review)Draft/ review briefing documents to support e.g. scientific advice procedures/ meetings with HALead/ coordinate/ communicate/ track activities to ensure submission deadlines are met in accordance with procedures: e.g....

  • Regulatory Affairs Manager/cmc

    vor 1 Monat

    Basel, Schweiz Coopers Group AG Vollzeit

    Regulatory Affairs Manager/CMC Duration: 30/10/2025, possible extension **Key Responsibilities**: - Manage timely responses to Health Authority (HA) questions (author/ review) - Draft/ review briefing documents to support e.g. scientific advice procedures/ meetings with HA - Lead/ coordinate/ communicate/ track/ activities to ensure submission deadlines...

  • Ra Cmc Manager

    vor 2 Wochen

    Basel, Schweiz Hobson Prior Vollzeit

    Hobson Prior are looking for a RA CMC Manager to join a brilliant pharmaceutical corporation on a contract basis located in Basel. Our client is focused on improving and prolonging the lives of many. Please note that to be considered for this role you must have the right to work in this location. **Key Responsibilities**: - For this position, you will be...

  • Ra Cmc Associate Manager

    Vor 2 Tagen

    Basel, Schweiz CTC Resourcing Solutions Vollzeit

    **The Life Science Career Network** Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking for an **Regulatory Affairs CMC Manager** **for 18 month contract role based in Basel, Switzerland.** As Associate Manager within our Global Regulatory Affairs CMC team, you...

  • Cmc Dossier Manager

    Vor 2 Tagen

    Basel, Schweiz Sobi Vollzeit

    **Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.** **CMC Dossier...

  • Vp, Global Cmc Regulatory Affairs

    vor 7 Monaten

    Basel, Schweiz Moderna Vollzeit

    **The Role**: **Here's What You’ll Do**: Provide leadership for regulatory CMC aspects of product development projects Lead and drive all CMC submission activities (planning, Review documents for submission-readiness, to ensure that all submissions conform to health authority guidelines Develop effective CMC regulatory strategies for submissions (e.g....

  • Director Regulatory Affairs Cmc and Operations

    Vor 5 Tagen

    Basel, Schweiz Abbott Laboratories Vollzeit

    Abbott Established Pharmaceuticals EPD is looking for a **Director Regulatory Affairs CMC & Operations***:To be based in our Divisional Headquarter in Basel-Allschwil, Switzerland **Primary Job Function**: - Provide strategic global regulatory guidance and leadership on CMC related matters for pipeline development products and on-market products for a...

  • Associate Director, Regulatory Affairs Cmc

    Vor 2 Tagen

    Basel, Schweiz Proclinical Vollzeit

    Proclinical are proud to announce our exclusive partnership with Ultragenyx Pharmaceuticals in support of their ongoing European expansion. Ultragenyx are a US based biotech committed to the development of innovative therapies for patients with serious rare and ultra-rare genetic diseases. Their unique approach has led to the successful development of...

  • Associate Director, Cmc Regulatory Affairs

    vor 7 Monaten

    Basel, Schweiz Moderna Vollzeit

    **The Role**: Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners...

  • Cmc Dossier Manager

    vor 1 Tag

    Basel, Schweiz Sobi Vollzeit

    **CMC Dossier Manager** The CMC Dossier Manager works in the Sobi Technical Operations Department within in the CMC Program Management unit. The role is responsible for technical oversight and the coordination of generation of CMC documentation. Within the scope is the source documentation for process development, process validation, GMP and non-GMP...

  • Regulatory Affairs Manager

    Vor 4 Tagen

    Basel, Schweiz Lonza Vollzeit

    Switzerland, Basel - Switzerland, Visp**Randstad Inhouse Services** is looking for a Regulatory Affairs Manager (M/F/d) for **Lonza AG** in Basel (100%). This is a **temporary **position for 12 months with an opportunity for an extension. Today, Lonza is a global leader in life sciences operating across three continents. While Lonza works in science,...

  • Head of Cmc Program Management

    Vor 6 Tagen

    Basel, Schweiz Sobi Vollzeit

    **Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.** **Head of CMC Program...

  • Head of Cmc

    Vor 6 Tagen

    Basel, Schweiz Sobi Vollzeit

    The Role As Head of CMC, you will ensure that late development and lifecycle plan are translated in sustainable reality. For this, you can rely on a team of CMC project lead and CMC dossier managers. They manage end to end complex technical CMC projects, including budget and reporting, CMC regulatory strategy and scientific writing. You will work closely...

  • Regulatory Affairs Manager

    vor 2 Wochen

    Basel, Schweiz Proclinical Vollzeit

    Proclinical are working alongside a pharmaceutical organisation who are recruiting for an individual to join their team. This role is on a contract basis. The opening position is for a Regulatory Affairs Manager. For more information, please get in touch now! **Responsibilities**: - Conduct regulatory evaluations for aberrations and change control. -...

  • Cmc Regulatory Project Coordinator

    vor 7 Monaten

    Basel, Schweiz Coopers Group AG Vollzeit

    **CMC Regulatory Project Coordinator** You will be repsonsible for coordinating the budget of the CMC development activities of the late stage phase within the CMC Development organization. You will collaboaret with internal and external partners to support deliverables according to project timelines and defined budget. **Responsibilities**: - Monitoring...

  • Regulatory Affairs Manager

    Vor 5 Tagen

    Basel, Schweiz CTC Resourcing Solutions Vollzeit

    The Life Science Career NetworkCTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in finding promising career opportunities and offer the latest in skill development training programmes.Our client, a global market leader in the production and process...