The RA will be responsible for timely planning, preparation and coordination of regulatory submissions and provide guidance to cross-functional teams on regulatory strategy and tactics. Tasks will include but are not limited to :
- Assist in the preparation and submission of regulatory documentation (licensed products) to ensure compliance with applicable guidelines.
- Support the coordination and tracking of regulatory projects and timelines.
- Maintain accurate records and databases for regulatory filings and correspondence.
- Collaborate with internal teams to gather necessary data and documents for submissions.
- Monitor and interpret regulatory requirements to ensure up-to-date compliance.
- Provide administrative support for regulatory meetings and audits.
- Contribute to the continuous improvement of regulatory processes and procedures.
- Stay informed about industry trends and regulatory changes affecting the LIFE SCIENCE sector.
A successful candidate should bring :
A degree or educational background in a relevant field such as life sciences or regulatory affairs.3-5 years` experience in a regulatory capacity ideally with licensed / marketed products in the pharma industry , experience with Swiss Medic is a Must-Have.Proficiency in English (work language); Technical German (write & read) e.g for labelling reviews, is a Must-Have.Ability to work independently and manage multiple tasks effectively in a fast paced work environment.Experience with documentation management, archiving systems, and regulatory tools (e.g. Veeva RIM).Our client offers you :
An opportunity to work within a reputable company in the LIFE SCIENCE sector.A collaborative and supportive team environment in BASEL.Exposure to diverse regulatory projects and processes.The chance to contribute to meaningful work in a growing industry.If you are ready to make an impact as an ASSOCIATE REGULATORY AFFAIRS in BASEL, we encourage you to apply today!