Job Description

** Position Overview:**

This position will provide strategic, tactical, and operational direction and support to expedite development of our client’s clinical trial portfolio by helping to develop successful regulatory strategies and submissions in support of clinical trials.

This position utilizes CMC technical knowledge to drive internal consistency and influence effective change management. This team will be expected to influence and execute regulatory strategies that can accelerate the development of assigned project(s).

** Job Responsibilities** :

Include but are not limited to:

• 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:**

• Bachelor’s Degree in a science discipline (chemistry, biology, biochemistry, or related scientific discipline).
• Three to five years in research and development or formulation role focused on large molecule/biologics drug substance/product development.
• Pharmaceutical industry experience in CMC technical drug development (drug substance and/or drug product experience in analytical development or formulation).

Preferred but Optional:

• Three or more years of direct global regulatory CMC experience, or equivalent experience supporting CMC functions contributing to clinical trial phases of development in various regions, including US, EU, and Asia.

Additional Information

• Position is full-time, working Monday-Friday 8:00 a.m.-5:00 p.m

• overtime as needed

• Candidates currently living within a commutable distance of Indianapolis, IN are encouraged to apply.

• Excellent full-time benefits including comprehensive medical coverage, dental, and vision options

• Life and disability insurance

• 401(k) with company match

• Paid vacation and holidays

• #LI-EB1

• Authorization to work in the United States indefinitely without restriction or sponsorship

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.