Manager Regulatory Affairs
vor 1 Woche
To 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 regulatory strategies, advice and provide clear guidance and information to internal and external stakeholders in Daiichi Sankyo
- Advise on national submission matters and any specific additional national requirements, identify deficiencies requiring resolution
- Prepare gap analyses of documentation vs. EU and global requirements
- In collaboration with the European and Global Regulatory Team plan, lead and manage regulatory submissions during development and life cycle management to Swissmedic
- Coordinate preparation of and prepare regulatory documents for submission, review regulatory and related documents for sign off prior to submission. This includes all national documents required for the submission and implementation of labelling and artwork
- Maintain licenses for approved products by handling the full regulatory lifecycle including line extensions, labelling and CMC variations, PSUR submissions, renewals etc., provide oversight and ensure regulatory compliance
- Keep current with, review and interpret regulatory legislation, guidelines and initiatives. Communicate important changes and trends within Regulatory Affairs and Swiss affiliate business functions. Design and revise SOPs and SOIs
- Provide launch support and advise on supply questions of medicinal products
- Represent Regulatory Affairs and/or Daiichi Sankyo in internal and external interactions and liaise with cross-functional groups at Swiss Affiliate, multidisciplinary local and multinational project teams and license partners. Build up strong relationship with internal and external stakeholders at the Swiss affiliate and EU head office
- Drive projects to enhance the functionality and improve processes of the organization and/or to adapt to the regulatory environment
***Education & Professional Experience**:
- Degree in Pharmacy, Medicine, Life or Natural Sciences
- Deep knowledge of Swiss national laws, guidelines and other requirements for human medicinal product marketing authorization and maintenance is essential
- Significant working experience (min 5 years) in Regulatory Affairs working with Swissmedic within the pharmaceutical industry with an emphasis on regulatory pre-submission and post-approval activities and preparation of new marketing authorization in Switzerland
- Experience in Oncology and with ORBIS is a plus
- Understanding of development and life-cycle management of drugs and regulatory processes including the regulatory requirements and processes in Europe
- Ability to interact and communicate effectively with regulatory authorities and stakeholders in a multinational environment
**Personal Skills**:
- Excellent interpersonal skills
- Ability to communicate and work across functions effectively in a multinational organization to accomplish results
- Be detailed-oriented, reliable, well organized and self-motivated
- Proven ability to plan, coordinate and lead activities simultaneously on multiple projects
- Very high ethical standards
- Native level German and excellent written and verbal communication skills in English; French and/or Italian is a plus
**Why work with us?**:
-
Regulatory Affairs Manager
vor 2 Wochen
Basel, Schweiz LHH VollzeitWe 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...
-
Manager, Regulatory Affairs, International
Vor 6 Tagen
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 1 Woche
Basel, Schweiz Proclinical VollzeitProclinical 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 6 Tagen
Basel, Schweiz NonStop Consulting VollzeitMy 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...
-
Associate Public Affairs 100%
Vor 2 Tagen
Basel, Schweiz SFL Regulatory Affairs & Scientific Communication VollzeitWould you like to join and contribute to an award-winning, successful and growing multi-national organization in the heart of Europe and one of the world’s leading regions of the pharmaceutical industry? SFL Group and its dynamic cross-functional team provide premium consulting support to companies in the healthcare and life sciences fields. Our clients...
-
Associate Medical Affairs 100%
Vor 2 Tagen
Basel, Schweiz SFL Regulatory Affairs & Scientific Communication VollzeitWould you like to join and contribute to an award-winning, successful and growing multi-national organization in the heart of Europe and one of the world’s leading regions of the pharmaceutical industry? SFL Group and its dynamic cross-functional team provide premium consulting support to companies in the healthcare and life sciences fields. Our clients...
-
Regulatory Affairs Manager, Animal Nutrition and
vor 2 Wochen
Basel, Schweiz DSM Vollzeit**DSM - Bright Science. Brighter Living.** **What you’ll do**: - As a Regulatory Affairs Manager, you will manage the regulatory compliance, market clearance, advocacy and business support of DSM animal nutrition products and provide advice to Marketing and Sales, Product Management, Global Regulatory in all regulatory related topics/issues for Animal...
-
Manager, Regulatory Affairs, International
vor 2 Wochen
Basel, Schweiz Sobi Vollzeit**Manager, Regulatory Affairs, International** One of Sobi’s four strategic pillars is to “Go Global”. The Manager, Regulatory Affairs International supports our ambitious geographical expansion plans. Sobi is seeking to register some of our existing portfolio into new territories and to register several of our development projects into the...
-
Regulatory Affairs
Vor 6 Tagen
Basel, Schweiz LGT VollzeitDie 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 Consultant
Vor 6 Tagen
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...
