Regulatory Affairs Manager

Vor 2 Tagen

Zug, Schweiz Johnson & Johnson Vollzeit

Johnson & Johnson is currently seeking a Regulatory Affairs Manager to join our local Regulatory Affairs team located in Zug, Switzerland. This role will be working in a hybrid working model.

We are looking for a highly motivated individual to join our team as a Regulatory Affairs Manager. In this position, you will play a crucial role in ensuring adherence to all regulatory requirements and successfully implementing our regulatory strategy. You will collaborate closely with cross-functional teams to create and implement regulatory plans that align with the company's goals and objectives.

Key Responsibilities:

- Secure and maintain Swiss marketing authorizations
- Develop and implement regulatory strategies to support product development and registration
- Prepare and manage regulatory submissions and correspondence with regulatory agencies
- Collaborate with internal teams to provide regulatory guidance and support
- Ensure compliance with applicable regulations and guidelines
- Stay current with regulatory requirements and changes in the regulatory environment

**Requirements**:

- Bachelor's degree in a scientific or related field
- Minimum of 5 years of experience in regulatory affairs
- Proven track record of successfully navigating regulatory processes
- Strong knowledge of regulatory requirements and guidelines
- Excellent communication and interpersonal skills
- Ability to work independently and collaboratively in a fast-paced, team-oriented environment
- Exceptional attention to detail and ability to manage multiple projects simultaneously
- Fluent in German and English, both written and spoken

**Qualifications**:
If you are a motivated and ambitious individual with a passion for regulatory affairs, we would love to hear from you. Join our world-class team at Johnson & Johnson and make a difference in the lives of millions of people around the world.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.

We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

  • Senior Manager Regulatory Affairs Europe

    Vor 2 Tagen

    Zug, Schweiz Tbwa ChiatDay Inc Vollzeit

    Senior Manager Regulatory Affairs EuropeCytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader...

  • Regulatory Affairs Manager

    Vor 4 Tagen

    Zug, Schweiz Proclinical Vollzeit

    Proclinical are recruiting a Regulatory Affairs Manager for a biotech corporation. This role is on a contract basis with the ability to work remotely in Europe. **Responsibilities**: - Handle the relationship with the Clinical Research Organisation contracted for some clinical studies. - You will assist with different regulatory proposals to the marketing...

  • Global Regulatory Affairs Manager, Vaccines

    Vor 2 Tagen

    Zug, Schweiz GSK Vollzeit

    **Site Name**: Belgium-Wavre, Italy - Siena, Switzerland - Zug, UK - London - New Oxford Street, USA - Maryland - Rockville, Warsaw Rzymowskiego 53 **Posted Date**: Oct 31 2024 **Global Regulatory Affairs Manager, Vaccines Therapeutic Group**: Job purpose: As a **Global Regulatory Affairs (GRA) Manager**, you will join the GRA Vaccines Therapeutic Group in...

  • Senior Manager, Regulatory Affairs CMC

    Vor 4 Tagen

    Zug, Schweiz Gilead Sciences Switzerland Sarl Vollzeit

    Description   The CMC (Chemistry, Manufacturing, and Controls) Regulatory Affairs International Affiliate Team is seeking a motivated, curious, flexible, and culturally aware experienced Regulatory professional to assume a full-time employment position in Gilead's office in Zug, Switzerland in the capacity of  CMC   Regulatory Affairs Senior...

  • Senior Manager, Regulatory Affairs CMC, Zug

    Vor 2 Tagen

    Zug, Schweiz TN Switzerland Vollzeit

    Social network you want to login/join with:Senior Manager, Regulatory Affairs CMC, ZugClient:Location:Job Category:OtherJob Reference:c5d7e2e6e8faJob Views:9Posted:21.01.2025Expiry Date:07.03.2025Job Description:DescriptionThe CMC (Chemistry, Manufacturing, and Controls) Regulatory Affairs International Affiliate Team is seeking a motivated, curious,...

  • Manager/associate Director

    Vor 6 Tagen

    Zug, Schweiz GSK Vollzeit

    **Site Name**: UK - London - New Oxford Street, Switzerland - Zug, UK - Hertfordshire - Stevenage **Posted Date**: Nov 25 2024 Are you interested in a highly visible regulatory affairs role that allows you to drive strategy and shape integrated regulatory development across portfolios? If so, this Regulatory Affairs CMC role could be an ideal opportunity to...

  • Intern Regulatory Affairs

    vor 1 Woche

    Zug, Schweiz Viatris Vollzeit

    7087 Mylan Pharma GmbH At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access - Providing high quality trusted medicines regardless of...

  • Regulatory Affairs Manager

    Vor 7 Tagen

    Zug, Schweiz Talentor Sweden AB Vollzeit

    **Responsibilities**: - Manages regulatory responsibilities associated with the development, support, and deployment of the Company’s non-medical and medical device software products. - Manages development and implementation of regulatory strategies and plans to support the timely introduction of new products and the possible preparation and review of...

  • European Regulatory Affairs

    Vor 4 Tagen

    Zug, Schweiz Proclinical Vollzeit

    Proclinical are recruiting a European Regulatory Affairs - CTA Liaison for a biotech corporation. This role is on a contract basis and is located in Zug. **Responsibilities**: - Collaborate with regulatory affairs consultants/service suppliers on CTA proposals. - Serve as a representative for EU regulatory affairs at cross-functional study management team...

  • Director, Eu Regulatory Affairs

    Vor 4 Tagen

    Zug, Schweiz Deciphera Pharmaceuticals Vollzeit

    Company Description Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative...

  • INTERNATIONAL REGULATORY AFFAIRS 60%

    Vor 3 Tagen

    Zug, Schweiz TN Switzerland Vollzeit

    Social network you want to login/join with:Client:gloor & lang Pharma and Biotech RecruitingLocation:Job Category:OtherJob Reference:d756a64d20ffJob Views:9Posted:21.01.2025Expiry Date:07.03.2025Job Description:Innovative Biologic submissions – early to late phaseOur client is an R&D driven biotech company based in Zurich. Own Research and development...

  • Regulatory Affairs Manager

    Vor 3 Tagen

    Zug, Schweiz TN Switzerland Vollzeit

    Location: BaarDuration: 02/09/2024 to 01/09/2025Key Responsibilities:Responsible for leading regulatory affairs activities for assigned projects and programs and for leading affiliate RA to identify and complete national regulatory requirements for assigned projects and programs, to support commercialization.Responsible for collaboration and relationship...

  • Associate Regulatory Affairs Director – Join Innovative TeamNonStop Consulting

    Vor 3 Tagen

    Zug, Schweiz TN Switzerland Vollzeit

    Social network you want to login/join with:Associate Regulatory Affairs Director – Join Innovative Team NonStop Consulting, ZugClient:NonStop ConsultingLocation:ZugJob Category:ConsultingJob Reference:633c09c2e42fJob Views:8Posted:21.01.2025Expiry Date:07.03.2025Job Description:Join a Leading Regulatory Affairs Team!About Our ClientWith a diverse portfolio...

  • Director Regulatory Affairs

    Vor 5 Tagen

    Zug, Schweiz Medison Pharma Vollzeit

    Medison commercializes highly innovative therapies across international markets, helping to save and improve the lives of patients suffering from the most challenging diseases. Medison has a deep expertise in local regulatory and market access know-how with uncompromising compliance excellence. It offers an affiliate-like partnership and tailored-solutions...

  • Senior Manager Regulatory Affairs International

    vor 1 Woche

    Zug, Schweiz Blueprint Medicines Vollzeit

    Location(s): SwitzerlandLevel of position: Senior ManagerPosition type: (office-based, in alignment with BlueFlex model*/field-based/)Reporting Line: International GRS LeadHow will your role help us transform hope into reality?Reporting to the International Regulatory Affairs Lead, the position will provide essential support in the planning and coordination...

  • External Consultant, Regulatory Affairs, Emea

    vor 1 Tag

    Zug, Schweiz Reata Contractors Vollzeit

    The External Consultant, Regulatory Affairs EMEA, will lead all the relevant regulatory activities related to an assigned nephrology program including coordination of MAA activities across the EMEA region. This role will ensures the timely and high quality execution of the EMEA regulatory strategy for the assigned program. **RESPONSIBILITIES**: -...

  • Regulatory Affairs Manager

    Vor 6 Tagen

    Zug, Schweiz Proclinical Vollzeit

    **Key responsibilities for this role will be**: - Planning, coordination and preparation of regulatory submissions to the EMA/MHRA, supporting the Global Regulatory Lead for products post MAA/MHRA approval(s) - Identify and assess regulatory risks associated with assigned project responsibilities and assist in defining strategies to mitigate risks -...

  • Regulatory Director for Combination Product

    Vor 2 Tagen

    Zug, Schweiz SHL Medical AG Vollzeit

    **Job Overview** The position of the Director Regulatory for Combination Product, Medical Devices and Emerging Technologies is based in the HQ of SHL Medical AG in Zug. It holds overall responsibility for Regulatory matters related to combination products, medical devices and emerging technologies. The holder is responsible for establishing applicable...

  • Senior Manager/Associate Director, Regulatory, International

    Vor 2 Tagen

    Zug, Schweiz Tbwa ChiatDay Inc Vollzeit

    Senior Manager/Associate Director, Regulatory, InternationalAbout BridgeBioBridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic...

  • Senior Manager, International Medical Affairs

    Vor 7 Tagen

    Zug, Schweiz Deciphera Pharmaceuticals Vollzeit

    We are searching for a highly motivated, insightful, and resourceful individual to join the Medical Affairs International team. The Senior Manager, International Medical Affairs is a highly visible and impactful role and will be instrumental in supporting and leading Medical Affairs activities for our commercial product (ripretinib) at European level and as...