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Role Purpose: The primary purpose of the Global Regulatory Affairs, CMC position is to provide Regulatory support and expertise for Elanco’s Marketed Product portfolio. The position is expected to work cross-functionally with Elanco Manufacturing and Quality to develop regulatory strategy, oversee submission preparation and meet the reporting requirements to maintain compliance of Elanco’s marketing authorizations. The role also executes CMC regulatory functions necessary to provide supplements/variation, renewals and annual reporting requirements for approved products.
Day to day responsibilities:
Ensure regulatory compliance for assigned Marketed Product portfolio.
Represent Global CMC Regulatory on post-approval teams.
Design/develop regulatory strategy and technical regulatory documents.
Assess manufacturing and quality related change requests.
Author high-quality CMC documentation (complete registration and/or variation packages), applying global CMC regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements.
Ensure the required documentation and any content, quality and/or timelines for global submissions are communicated to the appropriate teams and tracked accordingly.
Maintain a positive collaboration and partnership with internal groups in Regulatory, Quality and Manufacturing.
Facilitate and/or maintain a positive collaboration and partnership with global Health Authorities (US CVM, EMA, etc.), as applicable.
Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.
Fundamental knowledge of drug development process
Familiarity with the manufacturing process and controls associated with solid-oral dosage forms
Strong communication skills, both written and oral
Ability to make decisions when there is no clear right or wrong answer
Self-starter, takes initiative
Attention to detail
Quality and customer focused mindset
Strong organization and an ability to multi-task; able to handle multiple projects at different phases of development at the same time
Minimum Bachelor’s Degree with at least 5 years relevant work experience within the sciences
Must be able to speak and to write in English; Native language may differ from English
Technical expertise (manufacturing, analytical or quality background), especially in regards to solid oral dosage forms
GMP knowledge and experience, including quality assurance
Understanding of global regulatory requirements (US, EU, CA, etc.)
Previous people management experience (optional)
Ability to read and write in French (preferred)
Location: Basel, Switzerland
Reports to: Director-Global CM&C
Position will primarily support product that is manufactured at Elanco France (Huningue manufacturing site); onsite support required and dependent on local work laws
Travel requirements: approximately 10% domestic and international