Sr. Manager, Cmc Regulatory Science

vor 2 Wochen

Basel, Schweiz Moderna Vollzeit

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

Develop 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**:
Minimum Qualifications

BA/BS degree in a scientific/engineering discipline

8+ years of experience in the Pharmaceutical industry

4+ years of experience in Regulatory CMC, including DMF/ASMF submissions

Strong knowledge of current US and EU regulations and cGMP

Strong experience with CTD format and content regulatory filings

Exceptional written and oral communication

Preferred Qualifications

M.S. degree in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is desirable

12 years of experience in regulatory in the pharmaceutical/biotech industry

6+ years of experience in Regulatory CMC

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.

LI-PR1

  • Regulatory Cmc Manager

    Vor 5 Tagen

    Basel, Schweiz CTC Resourcing Solutions Vollzeit

    **The Life Science Career Network** Our client is a leading global player in the Pharmaceutical industry with global headquarters in Basel, Switzerland. They are undergoing a transformation with respect to culture and outside perception. The organisation focusses on novel therapies in Oncology and Ophthalmology and is also currently developing a...

  • Regulatory Affairs Manager Cmc

    Vor 5 Tagen

    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, Cmc Regulatory Science

    vor 2 Wochen

    Basel, Schweiz Moderna Vollzeit

    **The Role**: **Here’s What You’ll Do**: Develop/implement effective CMC regulatory strategies for global 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...

  • Regulatory Affairs Cmc Manager

    Vor 5 Tagen

    Basel, Schweiz SimplyVision GmbH Vollzeit

    For our customer located in Basel/Switzerland we are currently looking for a**: Regulatory Affairs CMC Manager **(M/F/x) **Tasks & Responsibilities / Must Haves** - Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation & publication of REG CMC documentation for...

  • Associate Director, Global Regulatory Science

    Vor 7 Tagen

    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...

  • Regulatory Affairs CMC Manager, Drug Substance

    Vor 4 Tagen

    Basel, Schweiz Trades Workforce Solutions Vollzeit

    Regulatory Affairs CMC Manager (Drug Substance – ADC focus) – Basel, Switzerland 📍 4 days on site / 1 day remote💶 Salary range: 105K–120K CHF Responsibilities: Lead Drug Substance (DS) CMC regulatory activities, focusing on antibody–drug conjugates (ADCs), chemical payloads, and bioconjugates. Author and review clinical regulatory submissions...

  • Ra Cmc Manager

    Vor 5 Tagen

    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...

  • Regulatory Affairs CMC Manager, Drug Substance, ADC

    vor 1 Woche

    Basel, Schweiz Barrington James Vollzeit

    OverviewJoin to apply for the Regulatory Affairs CMC Manager, Drug Substance, ADC role at Barrington James.Must be based/willing to travel to Basel, Switzerland4 days on site / 1 day remoteSalary range: 105K–120K CHFResponsibilitiesLead Drug Substance (DS) CMC regulatory activities, focusing on antibody–drug conjugates (ADCs), chemical payloads, and...

  • Basel CMC Regulatory Manager – ADC Drug Substance

    Vor 4 Tagen

    Basel, Schweiz Trades Workforce Solutions Vollzeit

    A leading workforce solutions provider is seeking a Regulatory Affairs CMC Manager for a role focused on drug substance, particularly antibody-drug conjugates (ADCs). The successful candidate will lead CMC regulatory activities, author submissions, and collaborate with external partners in Basel, Switzerland. A strong background in CMC processes and solid...

  • Regulatory Affairs CMC Manager, Drug Substance, ADC

    vor 2 Wochen

    Basel, Schweiz Barrington James Limited Vollzeit

    Must be based/willing to travel to Basel, Switzerland4 days on site / 1 day remote Salary range: 105K–120K CHF Responsibilities: Lead Drug Substance (DS) CMC regulatory activities, focusing on antibody–drug conjugates (ADCs), chemical payloads, and bioconjugates. Author and review clinical regulatory submissions from scratch (IMPD/IND, CTD Modules 2 &...