CMC Pre-Approval Regulatory Scientist
Our client, a global pharma company, is currently recruiting for a CMC Pre-Approval Regulatory Scientist to join their team on a permanent basis. This is an excellent opportunity to join a global team of regulatory experts. As CMC Pre-Approval Regulatory Scientist, you will partner with Global Regulatory Affairs – CMC (GRA-CMC) Regulatory Scientists to provide strategic, tactical, and operational direction and support to expedite CMC development of the organization's portfolio by developing successful regulatory strategies and submissions in support of clinical trials and marketing authorization applications. This role offers hybrid working.
Responsibilities: Assist in the development of regulatory strategy and update strategy based upon global regulatory changes.Provide high quality and timely regulatory advice to allow CMC teams to make well-informed decisions.Evaluate regulatory impact on proposed CMC development plans.Anticipate and resolve key technical or operational issues that can impact the function or CMC team.Participate in risk-benefit analysis for regulatory compliance.Provide regulatory guidance to CMC teams and implement regulatory strategies that enable timely study starts.Lead, prepare, review, and finalize CMC documents for global CTA submissions, marketing authorization applications, and responses to questions.Take a proactive leadership role in the critical review of molecule specific CMC development strategies and submission content.Make technical decisions on CMC regulatory issues impacting submissions across geographies.Network and gain alignment with CMC team members and GRA CMC scientists/line management to resolve complex issues.Develop relationships with CMC team members that promote open discussion of issues to enable regulatory influence of drug development strategies.Communicate effectively verbally and in writing within GRA CMC and with CMC development teams.Identify and resolve global CMC regulatory issues, leveraging internal experts to develop complex regulatory strategies.Requirements: Bachelor's Degree in science or engineering discipline (e.g., chemistry, biology, biochemistry, or pharmacy) with 10 – 12 years experience in CMC regulatory or drug substance or drug product development, commercialization, manufacturing, or quality.Or master's degree in science or engineering discipline (e.g., chemistry, biology, biochemistry, or pharmacy) with 5 – 7 years experience in CMC regulatory or drug substance or drug product development, commercialization, manufacturing, or quality.Less experience would be considered with a Pharm D or a Ph.D. degree in a related field.Prior experience authoring CMC submission content is desirable.Prior Regulatory CMC experience or equivalent combination of technical and regulatory guidance knowledge is desirable.Demonstrated strong written, spoken, and presentation communication skills.Demonstrated negotiation and influence skills.Demonstrated attention to detail.Demonstrated effective teamwork skills; able to adapt to diverse interpersonal situations.For more information, please contact Sinéad Cullen on +353879500821 or ******
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