Johnson & Johnson Careers
Regulatory Affairs Manager
Requisition ID: 1805685602W
Janssen is part of Johnson & Johnson Pharmaceuticals helping patients all over the world. The core areas of competence include hematology, oncology, immunology, CNS, PAH and virology. With the development of new products and innovative processes, the company has made significant contributions to the advancement of therapy for many illnesses. The World Health Organization included five drugs in its list of the most important medications.
Regulatory Affairs Manager
Under supervision of the Head, the RM is responsible for regulatory activities to support and grow the business in line with the company goals. This includes:
- Obtain and maintain marketing authorizations.
- Provide strategic input by participation in internal (e.g. CVTs) working groups to meet company objectives.
- Ensure fast introduction of new products and line extensions including new indications
- Maintain and support communications with Health Authorities and third parties
- Ensure regulatory compliance
- Streamline regulatory activities with other internal business partners
- Contribute to influencing regulatory environment through external stakeholders
- Coaching of junior colleagues
- Contribute to standardization/new systems and processes to ensure efficiency gains and to support business continuity
- Prepare and submit regulatory submissions with support from regulatory operations.
- Ensure deadlines for different projects are met or escalated to Head of RA.
- Maintain the product label and packaging in line with current registered authorization details according to the relevant local and EU legislation
- Contribute to compliance with all regulatory requirements (e.g. timely submission of dossiers, timely implementation of new national and international legislation, timely implementation and training of SOP’s & supporting systems …)
- Maintain an awareness of regulatory guidelines/directives/national requirements in order to provide appropriate advice.
- Support other departments based on their needs (logistic, quality, pricing, medical, marketing, sales)
- Contribute to positive relationships with the local health authorities, in general and on product-specific topics
- Support and contribute to GRA-EMEA initiatives
- Contribute to initiatives around lessons learnt and change management to ensure efficiency gains
- This role has no direct reports although needs to also support and coach further team members when needed
- Fluent in German and English
- Occasionally flexible work hours and reachable in case of emergencies
- Readiness to travel; amount of travel is mainly based on a case by case basis
- University Degree in Pharmacy, Biology, Chemistry or related Life Science
- Regulatory Affairs experience (5+ years) at both operational and strategic level with direct experience and strong knowledge of general regulatory requirements and guidelines
- Strong interpersonal, communication, teamwork and negotiation skills.
- Ability to manage multiple tasks, projects, priorities, and complex systems simultaneously in a matrix organization and participate effectively both independently and as part of multiple teams
- Ability to work under strict timelines, combined with flexibility when emergency situations require this
- Project management skills
- Knowledge of relevant IT-systems
- Basic understanding of pharmaceutical product development
- General understanding of business partners need’s
Janssen-Cilag Switzerland (7325)