Regulatory Affairs Director, Europe
vor 18 Stunden
Company Overview:
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) is a global, commercial-stage, research-based biotechnology company focused on molecularly targeted and immuno-oncology cancer therapeutics. With a global team of over 9,000 employees located in China, the United States, the EU, the UK, Switzerland and Australia, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for the treatment of cancer. BeiGene is working to create combination solutions aimed at having both a meaningful and lasting impact on cancer patients.
**Job Description**:
The Europe Regulatory Affairs Director will report to the Head of Regulatory Affairs Europe. The role will be responsible for developing and implementing European regulatory strategies for development programs to secure and maintain marketing authorization for products in line with business objectives, and in coordination with key internal stakeholders. This newly created role will:
- Develop European regulatory strategy for the designated projects, and contribute to the clinical development plans, especially for projects at early development stage
- Act as the representative of European regulatory team at the global regulatory team (GRT) for the designated projects
- Asist in the preparation, writing and review of regulatory documents, such as, IB, CTA, 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
- 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
- Lead and mentor team members
Core Competencies, Knowledge and Skill Requirements:
- Minimum of 15 years’ experience in the biotechnical or pharmaceutical industry, and a minimum of 8 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 CTAs, 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 and remote working possible
Competencies:
Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically;
- Upholds organizational values.
- Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.
Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.
Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.
Adaptability - Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.
Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.
Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.
Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully
Project Management - Communicates changes and progress; Completes projects on time
-
Regulatory Affairs Associate Director, Europe
vor 18 Stunden
Basel, Schweiz BeiGene VollzeitREGULATORY AFFAIRS Associate Director, Europe (with focus on Switzerland) Regulatory Affairs, Basel, Switzerland Reports To: Director, Team Lead of EU Regulatory Affairs **Job Description**: The (Swiss) Regulatory Affairs lead will report to the team lead of Regulatory Affairs Europe and will have dotted line reporting to the Swiss General Manager. The...
-
Director Regulatory Affairs
vor 7 Monaten
Basel, Schweiz BeiGene VollzeitGeneral 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...
-
Director Regulatory Affairs, Emea
Vor 2 Tagen
Basel, Schweiz Cochlear Ltd VollzeitDirector 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...
-
Basel, Schweiz BeiGene VollzeitGeneral Description: Under the direction of the General Manager Sub Region Europe, this individual is responsible for the local representation of regulatory affairs and quality assurance in SRE. The incumbent provides dynamic leadership, strategic direction and close oversight of all regulatory affairs and compliance activities in SRE across BeiGene's...
-
Director, Global Regulatory Affairs
vor 7 Monaten
Basel, Schweiz Ironwood Pharmaceuticals VollzeitVectivBio 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 7 Monaten
Basel, Schweiz Ironwood Pharmaceuticals VollzeitVectivBio 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...
-
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...
-
Associate Director Regulatory Affairs Biosimilars
vor 7 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...
-
Regulatory Affairs Associate Director, Digestive
vor 7 Monaten
Basel, Schweiz Bayer Vollzeit**At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...
-
Manager Regulatory Affairs
vor 7 Monaten
Basel, Schweiz Daiichi-Sankyo Europe VollzeitTo provide regulatory guidance and support and execute regulatory activities in Switzerland for approved products and development projects. **Roles & Responsibilities**: - Act as primary contact person for Swissmedic for assigned products, drive negotiations on regulatory matters - In close collaboration with the European and Global Regulatory Team develop...
-
Director Regulatory Affairs Cmc and Operations
Vor 6 Tagen
Basel, Schweiz Abbott Laboratories VollzeitAbbott 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 Biosimilars
vor 2 Monaten
Basel, Schweiz Abbott Laboratories VollzeitAbbott 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 countries.Abbott...
-
Basel, Schweiz Abbott VollzeitJOB DESCRIPTION: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...
-
Associate Director Regulatory Affairs Biosimilars
vor 2 Wochen
Basel, Schweiz Abbott Laboratories VollzeitAbbott 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 countries.Abbott...
-
Regulatory Affairs Manager
vor 18 Stunden
Basel, Schweiz Sandoz Vollzeit**Regulatory Affairs Manager, Novartis, Basel, Switzerland** 1 unique opportunity to join Regulatory Affairs Team! Person on this position will take care of all drug regulatory affairs matters regarding the assigned indication group. Acts as an interface between global Regulatory Affairs departments and Swiss medic in order to obtain new marketing...
-
Global Regulatory Affairs Director
vor 7 Monaten
Basel, Schweiz Coopers Group AG VollzeitGlobal 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...
-
Associate Director, Regulatory Affairs Cmc
Vor 3 Tagen
Basel, Schweiz Proclinical VollzeitProclinical 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...
-
Manager of Regulatory Affairs
Vor 5 Tagen
Basel, Schweiz Proclinical VollzeitProclinical 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...
-
REGULATORY AFFAIRS PROJECT MANAGER
Vor 6 Tagen
Basel, Schweiz Alira Health VollzeitJoin 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 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...
