Formulation Scientist Regulatory Affairs

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

Job summary

An established industry player seeks a skilled professional to lead the preparation and regulatory review of CMC sections for global submissions. This exciting role involves evaluating regulatory impacts, making technical decisions, and communicating effectively with teams to influence CMC development strategies. Join a dynamic environment where your expertise in large molecule drug development and regulatory affairs will help shape the future of pharmaceutical innovations. This full-time position offers excellent benefits and the opportunity to work within a collaborative team dedicated to advancing healthcare solutions.

Benefits

Comprehensive medical coverage

Dental and vision options

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Qualifications

• 3-5 years in R&D or formulation role focused on large molecule development.
• Experience in CMC technical drug development and regulatory issues.

Responsibilities

• Lead preparation and review of CMC sections for global CTA submissions.
• Provide regulatory advice to CMC teams for informed decision-making.

Skills

Regulatory Affairs

Technical Decision Making

Communication Skills

CMC Development Strategies

Education

Bachelor’s Degree in a science discipline

Job description

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

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.