Director Regulatory Affairs

vor 5 Monaten

Basel, Schweiz BeiGene Vollzeit

General Description:
The Director Regulatory Affairs will be responsible for developing and implementing regulatory strategies for the designated program to secure and maintain marketing authorization in line with business objectives, and in coordination with key internal stakeholders.

Essential Functions of the job:

- Act as the representative of European regulatory team at the global regulatory team (GRT) for the designated projects
- Lead the regulatory documents, such as, PIP, ODA, and briefing documents for interactions with European regulatory authorities
- Provide submission gap analyses, identify potential risks and propose potential solutions/mitigation plans to ensure successful acceptance of submissions and timely approvals
- Oversee and be accountable for regulatory agency communications, submissions, and approvals, with a quality focus to secure first-cycle/attempt approvals
- Lead and mentor team members
- Maintain up-to-date working knowledge of laws, regulations, and guidelines across the European regulatory authorities.
- Represent the Beigene European regulatory function at industry consortium (maybe required)
- Liaise with other line functions, e.g. legal, compliance, QA, CMC, Operations and Ad/Prormo/Labeling groups to ensure compliance and business continuity

Reports To: Senior Director - Team Lead Regulatory Affairs, Europe and New Markets

Education Required:
Degree in a scientific discipline, or equivalent

Other Qualifications:

- Minimum of 15 years’ experience in the biotechnical or pharmaceutical industry, and a minimum of 10 years’ experience in a Regulatory capacity with a broad background.
- Experience working with EMA for EU regulatory procedures is mandatory for this role.
- Sound understanding of the drug development process, the pharmaceutical industry and healthcare environment including Global and EU regulatory requirements and policy trends
- Recent experience with oncology products and MAAs, ODD, PIP is preferred
- Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism
- English native speaker is preferred and remote working possible

Location: Europe (remote possible), Switzerland is preferred

Supervisory Responsibilities:
Yes

Computer Skills: Efficient in Microsoft office 356 suite software, e.g., Word, Excel, Outlook, and Adobe

BeiGene Global Competencies

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
- Fosters Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Self-Awareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
- Continuous Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial Excellence
- Communicates with Clarity

We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

  • Regulatory Affairs Director

    vor 1 Monat

    Basel, Basel-Stadt, Schweiz Ironwood Pharmaceuticals Vollzeit

    Job SummaryWe are seeking a highly experienced and skilled Regulatory Affairs professional to lead our international regulatory strategy and team. The ideal candidate will have a strong background in pharmaceutical regulatory affairs, with a focus on global drug development and EU regulatory compliance.Key ResponsibilitiesDevelop and implement global...

  • Director, Global Regulatory Affairs

    vor 5 Monaten

    Basel, Schweiz Ironwood Pharmaceuticals Vollzeit

    VectivBio is a global, clinical-stage biotechnology company focused on the discovery, development, and commercialization of innovative treatments for severe rare conditions with high unmet medical need. VectivBio is now a part of Ironwood Pharmaceuticals, Inc., a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of...

  • Director, Global Regulatory Affairs

    vor 5 Monaten

    Basel, Schweiz Ironwood Pharmaceuticals Vollzeit

    VectivBio is a global, clinical-stage biotechnology company focused on the discovery, development, and commercialization of innovative treatments for severe rare conditions with high unmet medical need. VectivBio is now a part of Ironwood Pharmaceuticals, Inc., a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of...

  • Regulatory Affairs Director

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz Ironwood Pharmaceuticals Vollzeit

    Job Description for Regulatory Affairs Director at Ironwood PharmaceuticalsResponsibilities and Expectations Develop and lead global regulatory strategies for assigned projects or products across all phases of product development, ensuring timely development and implementation. Participate in or lead cross-functional task forces and initiatives,...

  • Regulatory Affairs Director

    vor 3 Wochen

    Basel, Basel-Stadt, Schweiz Ironwood Pharmaceuticals Vollzeit

    Key Responsibilities:As a crucial member of Ironwood Pharmaceuticals' Regulatory Affairs team, you will develop and implement global regulatory strategies for assigned projects and products, ensuring timely development and submission of regulatory materials. Your expertise will help navigate complex regulatory landscapes, drive strategic planning, and foster...

  • Associate Director Regulatory Affairs Biosimilars

    vor 5 Monaten

    Basel, Schweiz Abbott Laboratories Vollzeit

    **Abbott **is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160...

  • Global Regulatory Affairs Director

    vor 5 Monaten

    Basel, Schweiz Coopers Group AG Vollzeit

    Global Regulatory Affairs Director We are looking for a person who will develop/lead/implement regulatory strategy through a global regulatory team approach for assigned projects or product(s) across all phases of product development, and ensure timely development of regulatory strategy and operating plans. **Responsibilities** - Participate in or lead...

  • Regulatory Affairs Director

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz Lonza Vollzeit

    Lonza is a global leader in life sciences, operating across three continents. Our success is built on talented people working together to develop innovative solutions that improve human lives. We empower our employees to own their careers, fostering a work environment that values creativity, diversity, and collaboration.Key ResponsibilitiesAuthor and review...

  • Regulatory Affairs Manager

    vor 6 Monaten

    Basel, Schweiz LHH Vollzeit

    We have an exclusive mandate for one of our clients in Medical Devices based in Canton of Neuchatel. As a Regulatory Affairs Manager, you will be responsible for: - Support new product development by using in-depth knowledge and understanding of US domestic and international medical device, regulations (including 510k, and International dossiers) - Lead...

  • Associate Director, Regulatory Affairs

    vor 6 Monaten

    Basel, Schweiz VECTURA FERTIN PHARMA Vollzeit

    Contract Type: Permanent Closing date: Reference: VN1710 - Who we are - Vectura Fertin Pharma’s ambition is to become a market-leading wellness and healthcare business. Formed in March 2022, the business brings together two unique organizations: Vectura, experts in inhalation technology and Fertin Pharma, experts in oral and intra-oral delivery systems. -...

  • Associate Director Regulatory Affairs Small

    vor 5 Monaten

    Basel, Schweiz Lonza Vollzeit

    Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...

  • Regulatory Affairs Project Manager

    vor 1 Monat

    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 Manager

    Vor 7 Tagen

    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...

  • International Regulatory Affairs Intern

    vor 5 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 Specialist

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz Exponent Vollzeit

    Our OpportunityWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Exponent. This role will involve providing regulatory and technical expertise in Biocide Regulatory Affairs, working as part of a team to develop and implement regulatory strategies for the approval of new and existing active substances.You will be responsible...

  • Regulatory Affairs Team Lead

    vor 3 Wochen

    Basel, Basel-Stadt, Schweiz Straumann Group Vollzeit

    Job Title: Regulatory Affairs Team LeadAbout the Role:We are seeking a highly skilled Regulatory Affairs Team Lead to join our team at Straumann Group. The successful candidate will be responsible for ensuring that all products in scope are designed, manufactured, and distributed in accordance with applicable regulatory requirements.Main Responsibilities:*...

  • Regulatory Affairs Specialist

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz bruederlinpartner Vollzeit

    Ausgezeichnete Gelegenheit für eine neue HerausforderungWir suchen einen erfahrenen Regulatory Affairs Manager, der unsere Kunden in der Region Basel unterstützen möchte.Ihre AufgabenLeitung und Koordination von regulatorischen ProjektenErstellung und Einreichung von Zulassungsanträgen und -verlängerungenInteraktion mit nationalen und internationalen...

  • Regulatory Affairs Manager

    vor 3 Wochen

    Basel, Basel-Stadt, Schweiz bruederlinpartner Vollzeit

    Die Rolle als Regulatory Affairs ManagerWir suchen einen erfahrenen Regulatory Affairs Manager, der unsere Kunden in der Schweiz unterstützen kann. Als Teil unseres Teams werden Sie komplexe regulatorische Projekte leiten und die Einhaltung nationaler und internationaler Gesundheitsvorschriften überwachen.Ihre AufgabenLeitung und Koordination von...

  • Regulatory Affairs Team Leader

    vor 1 Monat

    Basel, Basel-Stadt, Schweiz Straumann Group Vollzeit

    Job Title: Team Leader Regulatory AffairsJob Summary:We are seeking a highly skilled Team Leader Regulatory Affairs to join our team at Straumann Group. As a key member of our regulatory affairs team, you will be responsible for ensuring that our products meet all applicable regulatory requirements and are safe and effective for their intended use.Main...

  • Regulatory Affairs Expert

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz gloor&lang AG Vollzeit

    Projektberatung und -managementWir suchen einen erfahrenen Regulatory Affairs Experten, der sich in der Zulassung von Arzneimitteln in der Schweiz auskennt. Der Kandidat wird in der Projektleitung und -begleitung von internationalen Kunden tätig sein.Beratung zu Einreichungsstrategien in der Schweiz und Vorbereitung von...