What are the responsibilities and job description for the Formulation Scientist - Regulatory Affairs position at Eurofins PSS Insourcing Solutions?
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.
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.
