Job Description

POSITION OVERVIEW:

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

In order to meet client expectations, it is necessary for our entire PSS team to develop collegial and mutually productive relationships with CMC team members. 

This position utilizes CMC technical knowledge and regulatory expertise 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:

• Leads preparation, technical and regulatory review and finalization of CMC sections for global CTA submissions and response to questions.
• Takes a proactive leadership role in the critical review of molecule specific 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.
• Networks and gains alignment with CMC team members and GRA-CMC regulatory scientists to resolve complex issues.
• Assists in the development of regulatory strategy and update strategy based upon global regulatory changes
• 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
• Anticipates and resolves key technical or operational issues that can impact the function or CMC team.
• Participates in risk-benefit analysis for regulatory compliance.
• Develop relationships with CMC team members that promote open discussion of issues to enable regulatory influence of drug development strategies.
• Communicates effectively verbally and in writing to influence within GRA-CMC and with CMC development team.
• Demonstrated negotiation and influence skills. Demonstrated effective teamwork skills, able to adapt to diverse interpersonal styles.
• Proactively identifies and resolves global CMC regulatory issues.
• 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

THE IDEAL CANDIDATE WOULD POSSESS:

• Five or more years of 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 Workload and forecasting experience

MINIMUM QUALIFICATIONS:

• Bachelor’s Degree in a science discipline (chemistry, biology, biochemistry, pharmacy or related scientific discipline)
• At least two years of 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
• Experience in authoring of CTA CMC submission content and responses to questions.
• Technical knowledge of CMC drug development sciences.
• Pharmaceutical industry experience in CMC technical drug development (drug substance and/or drug product experience in development, commercialization, or manufacturing).

Additional Information

Position is full-time with overtime as needed. Candidates currently living within a commutable distance of INDIANAPOLIS, IN are encouraged to apply.

WHAT WE OFFER:

• 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

Eurofins Lancaster Laboratories Professional Scientific Services® (PSS) is a global, award-winning insourcing solution that places our people at our clients’ site dedicated to running and managing laboratory services while eliminating headcount, co-employment and project-management worries.

We infuse our 55-year track record of scientific and laboratory operations expertise, as well as HR and great place to work best practices, to recruit, hire, train and manage highly qualified scientists to perform laboratory services using our client’s quality systems and equipment.

To learn more about Eurofins Lancaster Laboratories, please explore our website www.eurofinsus.com.

EUROFINS IS A M/F, DISABLED, AND VETERAN EQUAL EMPLOYMENT OPPORTUNITY AND AFFIRMATIVE ACTION EMPLOYER.