- Leads preparation, technical and regulatory review, and finalization of CMC sections for global CTA submissions and responds to questions.
- Takes a proactive leadership 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.
- 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 GRA-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.
- 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. Or 5 years' experience in large molecule/biologics research and development or formulation
- Bachelor's Degree in a science discipline (chemistry, biology, biochemistry, or related scientific discipline)
- Technical knowledge of large molecule/biologics CMC drug development sciences.
- Pharmaceutical industry experience in CMC technical drug development (drug substance and/or drug product experience in development, commercialization, or manufacturing).
- At least 3 years of large molecule/biologics in global regulatory CMC, research and development, or formulation.
- Experience in authoring of CTA CMC submission content and responses to questions in various regions, including US, EU, and Asia
- 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
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Chemistry Manufacturing Controls - Indianapolis, United States - Eurofins USA PSS Insourcing Solutions
Description
Job Description
Job DescriptionCompany DescriptionEurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.
The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.
In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.
In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.
Job DescriptionPosition 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.
In order to meet client expectations, it is necessary for our entire PSS team to develop collegial and mutually productive relationships with client GRA-CMC team members and other key stakeholders.
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:
Include but are not limited to:
The Ideal Candidate would possess:
Minimum Qualifications:
Preferred but Optional:
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
