G1 Therapeutics
  • Durham, NC, USA
  • Contract

THIS IS A CONTRACT OPPORTUNITY

Sr. Manager, CMC Regulatory Affairs

Responsibilities:

  • With oversight from the Director of CMC Regulatory, prepare regulatory filings for submission to US and international health agencies in the area of new drug development and marketing applications. This may include drafting and/or review of regulatory submissions.
  • Ensure regulatory submissions are of high quality and submitted in a timely manner, review submissions for accuracy, completeness, and compliance with applicable regulatory requirements and internal procedures.
  • Participate as CMC regulatory affairs representative on assigned projects, as needed, and assist development teams by providing current regulatory information and guidance on a proactive basis.
  • Manage the CMC regulatory affairs projects, initiatives & actions along with prioritizing assigned workload appropriately.
  • Manage regulatory issues, maintain submission information in relevant CMC systems, track regulatory commitments & timelines for specific projects/products/markets with minimal supervision.
  • Assist in the evaluation of manufacturing processes and changes, contributes to the assessment of regulatory implications and supporting their implementation.
  • Review and provide regulatory advice for documents prepared by other departments.
  • Interact proactively with other functions, contract research/manufacturing organizations and health authorities as required.
  • Work effectively with CMC and regulatory group to continuously improve regulatory systems, teamwork, and efficiency.

Requirements:

  • Minimum B.S. in scientific discipline; or acceptable complementary experience in the pharmaceutical/ biotechnology industry
  • Minimum 7 years' pharmaceutical industry experience, with a minimum of 4 years in CMC Regulatory Affairs.
  • Comprehensive understanding of global regulatory requirements; ability to interpret and apply the regulations to specific projects (FDA and ICH or other regulatory agency guidance requirements.)
  • Possess working knowledge of chemistry, analytics and pharmaceutical technology and of the drug development process.
  • Experience preparing CMC regulatory submissions in US and EU, such as IND, CTA and IMPD submissions and amendments, and annual report/DSUR submissions.
  • Global experience desirable
  • Experience operating within GXP related SOPs
  • Strong project management, written and verbal communication skills; attention to detail.
  • Must be able to work independently with minimal supervision.
  • Ability to work successfully within a cross-functional team, demonstrated flexibility and open to suggestions.

 

G1 Therapeutics provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. G1 Therapeutics complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

G1 Therapeutics
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