Regulatory Submissions Specialist
Our client, a dynamic global bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking for a Regulatory Data Management Associate in EMEA RMC for a contract until the 31st December 2019 based in the Basel area.
The RMC Data Management Associate responsible to cooperate with RMC Submission Management, Labeling Management and LOC respective RA staff on label changes and CMC variations.
- Executes Regulatory strategies in compliance with relevant laws, regulations, and organizational requirements necessary to obtain, and maintain, legal market status.
- Perform specialized activities in the submission process for all countries within their cluster or even region including:
- Data and record management (ie timely preparation, completion and approval of country records, archiving relevant submission and approval documents, closing record) .
- Ensure compliance/audit readiness within own tasks considering all applicable procedural documents .
- Constant updates of records documenting .
- Give inputs on internal processes improvements, database projects, updates and implementations.
- Assesses the impact of current regulatory requirements on the business to assist in the development of innovative Regulatory strategies and/or innovative ways to execute them.
- Responsible for all RA Databases (including but not limited to InSight/GRAIL/SPS/Trackwise)
- Manages multiple and changing priorities based on factors such as time constraints, urgency, and business need.
Qualifications and Experience:
- Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent.
- At least 3 years of regulatory experience with exposure to EMEA regulations, submissions and variations.
- Previous experience with InSight/GRAIL/SPS/Trackwise.
- Exhibits curiosity and passion to continuously learn about new scientific, technological, and Regulatory developments and explains Regulatory impact of risks to business partners
- Outstanding command of English, spoken and written.
- Relevant working/residency permit or Swiss/EU-Citizenship required.