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Global Regulatory Affairs Specialist - CMC in Fort Worth, TX at Apex Life Sciences

Date Posted: 12/7/2018

Job Snapshot

Job Description


Apex is seeking Global Regulatory Affairs Specialist to provide tactical and strategic leadership on complex CMC projects by actively contributing to the development and implementation of global CMC regulatory strategies throughout the lifecycle of pharmaceuticals/devices.

Responsibilities

  • Independently lead global regulatory strategy development, planning, and implementation for multiple complex programs and platforms.
  • Participate in identification of risk areas and develop alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans.
  • Guide and influence technical groups in areas of product lifecycle management and enhancement.
  • Support the negotiating and decision making with regulators and stakeholders with complex and high-risk projects.
  • Develop and implement regulatory strategy aligned with business strategy.
  • Assess impact of new regulations and implement appropriate changes
  • Support the Initiation and maintenance of appropriate communication within the RA function and stakeholders
  • Participate in Due Diligence activities
  • Interpret, apply and implement global regulations to CMC projects and prepare CMC regulatory submissions.
  • Actively participate in project team meetings and provide leadership in meeting submission goals
  • Identify and manage resolution to routine and complex issues including regulatory risk and provide risk/benefit strategies

Qualifications

  • B.S. required in related scientific discipline with 9+ years of regulatory experience
  • MS degree and 6+ years of regulatory experience.
  • PhD and 2+ years of regulatory experience.
  • Knowledge in Global responsibility for regulatory submissions required
  • Experience in a pharmaceutical manufacturing facility/development laboratory preferred.
  • Must have experience in support of global registrations
  • Sound basis of Scientific (Training/Communications) knowledge in multiple areas
  • Expert knowledge of regulations, and experience with interpretation and application
  • Excellent written and verbal communication, presentation, and facilitation skills
  • Strong negotiation skills and significant experience in interacting with regulatory authorities
  • Risk identification and problem solving skills

***For immediate consideration, please email your updated resume to ksavas@apexlifesciences.com with 'Global Regulatory Affairs Specialist - CMC' in the subject line.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




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