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!
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