Sr. Manager, Regulatory Affairs

vor 2 Wochen

Basel, Schweiz Moderna Vollzeit

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

- Develop and contribute to content, format and accountability for regulatory submissions and related supplements and amendments, including National Scientific Advice (NSA) meeting requests, briefing books, orphan drug designations, MAA etc.)
- Work with the Director-RA International, Reg-CMC, and Global Regulatory Sub-Teams regarding the development and execution of regulatory strategy in Switzerland
- Responsible for coordinating aspects of regulatory submissions relevant to assigned projects or programs
- Identify and assess regulatory risks for assigned projects or programs
- Interact with Swissmedic to assigned projects or programs, as appropriate
- Ability to work both independently and within project teams, committees, etc. to achieve group goals
- Prepare and deliver effective communications and presentations for external and internal audiences

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

- Degree in Life Science or related discipline, advanced degree preferred (PharmD, MSc, PhD)
- 5+ years of experience in the Pharmaceutical industry. 3+ years of experience in Regulatory strategy
- Strong knowledge of current Swiss regulations
- 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

**About Moderna**
In 10 years since its inception, Moderna has transformed from a science 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 six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. 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 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 Manager

    vor 2 Monaten

    Basel, Schweiz Boehringer Ingelheim (Schweiz) GmbH Vollzeit

    Innovative Medikamente für Mensch und Tier: Dafür steht das forschungsbasierte Pharmaunternehmen Boehringer Ingelheim seit über 130 Jahren. Boehringer Ingelheim zählt zu den 20 führenden Unternehmen der Branche und ist auch heute noch ein Familienunternehmen. Jeden Tag schaffen rund 52.000 Mitarbeiter Werte durch Innovation in den drei...

  • Regulatory Affairs Manager Schweiz

    vor 1 Monat

    Basel, Schweiz gloor&lang AG Vollzeit

    --- | MA holder - Arzneimittel - Projekte - QA Aufgaben | Unser Kunde ist ein Beratungs- und Dienstleistungsunternehmen im Raum Basel. Nationale und internationale Pharma und Healthcare Unternehmen werden zu regulatorischen und qualitätstechnischen Fragen beraten und aktiv betreut. Ein vielseitiges Portfolio wird im Auftrag der zahlreichen Kunden betreut. ...

  • Regulatory Affairs Manager Schweiz

    vor 1 Monat

    Basel, Schweiz gloor&lang AG Vollzeit

    --- | MA holder - Arzneimittel - Projekte - QA Aufgaben | Unser Kunde ist ein Beratungs- und Dienstleistungsunternehmen im Raum Basel. Nationale und internationale Pharma und Healthcare Unternehmen werden zu regulatorischen und qualitätstechnischen Fragen beraten und aktiv betreut. Ein vielseitiges Portfolio wird im Auftrag der zahlreichen Kunden betreut. ...

  • Manager, Regulatory Affairs, International

    vor 2 Wochen

    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.** **Manager, Regulatory...

  • 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. -...

  • Drug Regulatory Affairs Manager

    vor 2 Wochen

    Basel, Schweiz NonStop Consulting Vollzeit

    My client is offering an amazing opportunity to work on site in Basel for 18 months as a Drug Regulatory Affairs Manager. During your time in this role you will also have the opportunity of growth and promotion giving you the possibility of earning even more money over the period of the contract. If this sounds like it is something for you click below and...

  • Regulatory Affairs Project Manager

    vor 3 Monaten

    Basel, Schweiz Alira Health Vollzeit

    Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others. Job Description...

  • REGULATORY AFFAIRS PROJECT MANAGER

    Vor 5 Tagen

    Basel, Schweiz Alira Health Vollzeit

    Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others. Job Description...

  • Regulatory Affairs

    vor 2 Wochen

    Basel, Schweiz LGT Vollzeit

    Die LGT ist die weltweit grösste Private Banking und Asset Management Gruppe im Besitz einer Unternehmerfamilie. Als Family Office des Fürstenhauses von Liechtenstein überzeugen wir Sie mit langjähriger Erfahrung in der Verwaltung grosser Vermögen. Stellenbeschreibung Für unsere langfristige Weiterentwicklung im Intermediär-Geschäft übernehmen Sie...

  • 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,...

  • Regulatory Affairs Consultant

    vor 2 Wochen

    Basel, Schweiz NNIT Vollzeit

    **Regulatory Affairs Consultant** - Use your pharmaceutical experience to transform Regulatory Affairs_ NNIT is looking for Consultants with a deep pharmaceutical expertise and regulatory insight keen on making a mark on some of the most exciting digital transformations projects within the Life Sciences industry. The NNIT Life Sciences Consulting team is at...

  • Global Regulatory Affairs Manager

    vor 2 Wochen

    Basel, Schweiz EDP Personalberatung Vollzeit

    **#Pharma #RegulatoryAffairs***: Our customer, a **pharmaceutical company based near Basel**, needs reinforcement. For a **temporary employment** **, **we are looking for a **Global Regulatory Affairs Manager (M/F/d), 100%**: **Jetzt bewerben** **Major accountabilities**: - Lead the joint efforts for the development of the global product approval...

  • Manager, Regulatory Affairs Emea

    vor 7 Monaten

    Basel, Schweiz Ultragenyx Pharmaceutical Vollzeit

    **Why Join Us?** - Be a hero for our rare disease patients_ Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth - so employees can thrive in all areas of their lives, in and outside...

  • International Regulatory Affairs Manager

    vor 7 Monaten

    Basel, Schweiz Sobi Vollzeit

    **Company Description** 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. One...

  • Regulatory Affairs Project Manager

    vor 2 Wochen

    Basel, Schweiz NonStop Consulting Vollzeit

    My client is offering an amazing opportunity to work on site in Basel for 7 months as a Regulatory Affairs Project Manager. During your time in this role you will also have the opportunity of growth and promotion giving you the possibility of earning even more money over the period of the contract. **Requirements**: 3+ years Regulatory experience in a...

  • Manager of Regulatory Affairs

    Vor 4 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...

  • International Regulatory Affairs Intern

    vor 7 Monaten

    Basel, Schweiz Mirum Pharmaceuticals Vollzeit

    **MISSION**: **Job Summary**: As an Intern in Regulatory Affairs International team, you will work closely with the regulatory affairs team to ensure compliance with applicable regulations, standards, and guidelines governing the development, manufacturing, and marketing of pharmaceutical products. This entry-level position provides an excellent opportunity...

  • Regulatory Affairs Manager

    Vor 4 Tagen

    Basel, Schweiz BÜHLMANN Laboratories AG Vollzeit

    **BÜHLMANN Laboratories AG **ist eine international tätige und innovative Produktions - und Handelsfirma im Bereich Life Sciences. Das Unternehmen mit Hauptsitz in Schönenbuch beschäftigt mehr als 120 Mitarbeitende und ist global aktiv. Die selbst entwickelten und hergestellten diagnostischen Kits und Reagenzien werden weltweit als **in vitro...

  • Regulatory Affairs Manager

    vor 2 Wochen

    Basel, Schweiz Spring Professional Vollzeit

    Für unseren Kunden mit Firmensitz im Grossraum Basel - ein innovatives, global vernetztes, pharmazeutisches Unternehmen, mit über 25 Jahren Erfahrung - suchen wir zum nächstmöglichen Zeitpunkt einen Regulatory Affairs Manager (m/w/d). Ein familiärer Umgang, flache Hierarchien sowie eine täglich gelebte Wertschätzung zeichnen unseren Kunden aus. Haben...

  • Director Regulatory Affairs, Emea

    vor 1 Tag

    Basel, Schweiz Cochlear Ltd Vollzeit

    Director Regulatory Affairs, EMEA **Job no**: 615328 **Work type**: Permanent **Location**: Basel **Categories**: Quality & Regulatory, Western Europe, People Manager **About Us** Imagine using your experience to help people around the world to hear again. We can offer a unique opportunity to join Cochlear, an iconic Australian company, leading the...