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Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

CMC Pre-Approval Regulatory Scientist


Reference:SCA013828 Location: Cork
Qualification:DegreeExperience:7-9 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Regulatory Affairs, Regulatory Affairs Executive, Regulatory Affairs Manager, Regulatory Affairs Officer, Regulatory Affairs Specialist

CMC Pre-Approval Regulatory Scientist
Our client, a global pharma company, are 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 very strong 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 organisations 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
  • Provides regulatory guidance to CMC teams and implements regulatory strategies that enable timely study starts
  • Lead, prepare, review and finalise CMC documents for global CTA submissions, marketing authorization applications, and response 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 or related scientific discipline) 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 or related scientific discipline) 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 ss
For more information, please contact Sinéad Cullen on +353879500821 or [email protected]