What are the responsibilities and job description for the Formulation Scientist position at Eurofins USA PSS Insourcing Solutions?
Job Description
Job Description
Company Description
If you're experienced in pharmaceutical formulations or chemistry manufacturing and controls, but you're interested in taking your career into a non-lab, regulatory affairs space, this is a great opportunity for a career pivot!
Job Description
- Leads preparation, technical, and regulatory review and finalization of CMC sections for global CTA submissions
- Takes a proactive role in the critical review of molecule specific GRA-CMC development strategies and submission content.
- Makes technical decisions on CMC regulatory issues impacting product submissions across geographies, with support or guidance from Client GRA-CMC regulatory scientists.
- Provide high quality, timely and clear regulatory advice to allow CMC teams to make well-informed decisions
- Evaluate regulatory impact on proposed CMC development plans
- Communicates effectively verbally and in writing to influence within GRA-CMC and with CMC development team.
- Partners with Client GRA CMC (regulatory scientists) develop complex regulatory strategies.
- Partners with Client RDE (regulatory associates / publishing group) to ensure completion of submission activities.
Qualifications
Minimum Qualifications :
Preferred but Optional :
Additional Information
LI-EB1
Eurofins USA PSS Insourcing Solutions is a M / F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
