GE HealthCare

Associate Director, Regulatory Affairs, CMC

GE HealthCare

full-time

Posted on:

Location Type: Remote

Location: United States

Visit company website

Explore more

✨ AI Apply
Apply

Salary

💰 $132,000 - $198,000 per year

Job Level

Senior

About the role

  • To be the regulatory CMC strategy point of contact for project teams and to provide CMC related regulatory input for the assigned projects/products
  • Build, or provide input to, submission strategy documents by defining supplement type, data required to support submission, and submission documents required for the submission package
  • Guide the project team in the project planning phase so that the correct data (and level of detail) to suit the needs of all markets is collected and submitted
  • Author and review individual CMC submission documents/CMC dossier sections to support regulatory submissions
  • Provide consistent expert advice to the organization, determining feasible regulatory strategies and identify potential options, to assist in delivering optimal business value or mitigate compliance issues
  • Maintain registration tracking information and assist in the development of good document management practice standards
  • Work closely with global RA and, regional RA’s to address questions from regulatory authorities

Requirements

  • Advanced degree in pharmacy, radiopharmacy, pharmaceutical sciences, chemistry, or related discipline (Doctor of Pharmacy (PharmD) or MSc in radiopharmacy preferred)
  • Minimum 3 years of experience in Regulatory Affairs or Quality, with a track record of supporting marketed products and/or clinical development of radiopharmaceuticals
  • Familiarity with PET production, automated synthesis (cassette-based systems), and GMP requirements for radiolabeled compounds
  • Experience with regulatory submissions for post-approval changes, including FDA supplements and EU variations
  • Ability to prioritize, plan & evaluate deliverables to established strategic goals for complex projects, including scientific discussions on how best to present information
  • Strong problem solving and negotiation skills
  • Demonstrated experience of operating in a highly regulated environment
  • Capable of applying analytical skills in a CMC regulatory environment
  • Has experience working within a matrix organization and has strong interpersonal and influencing skills to work across disciplines
  • Has the capability to influence managers and help drive decisions at a project level
  • Demonstrated knowledge & experience in scientifically related field e.g. pharmaceutical sciences, chemistry and analytical sciences
  • Demonstrated strong ability in written and oral English in order to clearly and concisely present information targeted to the relevant audience
  • Experience in pharmaceutical CMC regulatory or QA environment particularly with experience with injectable diagnostic or pharmaceutical products
  • Ability to interpret global regulations and present to the wider business
  • Experience in electronic document management and Quality management systems
  • Ability to proactively champion projects & experienced in mentoring team members
  • Knowledge of international CMC regulatory requirements
  • Strong interpersonal skills and ability to engage effectively with colleagues at all levels
  • Prior regulatory agency interaction experience (e.g., query responses, scientific advice, deficiency letters)
  • Experience of global regulatory affairs from the pharmaceutical and/or healthcare industry
  • Experience of regulatory project management and regulatory agency interactions
  • Experience with Veeva RIM or other registration tracking tools
  • Ability to work across cultures/countries/sites
  • Demonstrated experience of prioritizing conflicting demands from multiple business entities in an extremely fast paced environment
Benefits
  • medical, dental, vision
  • paid time off
  • a 401(k) plan with employee and company contribution opportunities
  • life, disability, and accident insurance
  • tuition reimbursement
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory affairsquality assuranceCMC submissionsGMP requirementsanalytical skillsregulatory project managementregulatory submissionsPET productionautomated synthesispharmaceutical sciences
Soft Skills
problem solvingnegotiation skillsinterpersonal skillsinfluencing skillsmentoringprioritizationplanningcommunicationanalytical thinkingadaptability
Certifications
Doctor of Pharmacy (PharmD)MSc in radiopharmacy