Formulation Scientist - Regulatory Affairs

Eurofins PSS; Indianapolis (IN); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Formulation Scientist for a pivotal role in Regulatory Affairs. This full-time position is perfect for those with a background in pharmaceutical formulations looking to transition into a non-lab environment. The role involves leading the preparation and technical review of CMC sections for global submissions, making critical technical decisions on regulatory issues, and providing clear regulatory guidance to support CMC teams. With comprehensive benefits and a supportive work environment, this opportunity is ideal for professionals eager to influence drug development strategies across multiple regions.

Benefits

Comprehensive medical coverage

Dental and vision coverage

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Qualifications

• 3-5 years in R&D or formulation roles focused on large molecule development.
• Experience in pharmaceutical industry CMC technical drug development.

Responsibilities

• Leads preparation and review of CMC sections for global submissions.
• Provides regulatory advice to support CMC teams' decision-making.

Skills

Regulatory Affairs

Pharmaceutical Formulations

Technical Review

CMC Strategies

Communication Skills

Education

Bachelor’s Degree in Science

Job description

Formulation Scientist - Regulatory Affairs

If you're experienced in pharmaceutical formulations or chemistry manufacturing and controls, but interested in transitioning into a non-lab, regulatory affairs role, this is a great opportunity for a career pivot!

• Leads preparation, technical review, and finalization of CMC sections for global CTA submissions.
• Proactively reviews molecule-specific GRA-CMC development strategies and submission content.
• Makes technical decisions on CMC regulatory issues affecting product submissions across regions, with support from Client GRA-CMC regulatory scientists.
• Provides high-quality, timely, and clear regulatory advice to support informed decision-making by CMC teams.
• Evaluates the regulatory impact on proposed CMC development plans.
• Communicates effectively both verbally and in writing to influence GRA-CMC and CMC development teams.
• Partners with Client GRA CMC regulatory scientists to develop complex regulatory strategies.
• Collaborates with Client RDE (regulatory associates/publishing group) to ensure completion of submission activities.

Minimum Qualifications:

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

Preferred but Optional:

• Three or more years of global regulatory CMC experience or supporting CMC functions during clinical trial phases across regions such as US, EU, and Asia.

Additional details:

• Full-time position, Monday-Friday, 8:00 a.m. - 5:00 p.m., with overtime as needed.
• Candidates residing within a commutable distance of Indianapolis, IN are encouraged to apply.
• Benefits include comprehensive medical, dental, and vision coverage, life and disability insurance, 401(k) with company match, paid vacation and holidays.
• Authorization to work in the United States without restriction or sponsorship.

#LI-EB1

Eurofins USA PSS Insourcing Solutions is an Equal Employment Opportunity employer, supporting Disabled and Veteran applicants.