Parexel

CMC Regulatory Affairs Associate, M3 Authoring Experience for Biological Products

Parexel

full-time

Posted on:

Location Type: Remote

Location: Mexico

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About the role

  • Author global CMC variation submissions, annual reports, renewals, and post-approval MAA roll-outs, including responses to Health Authority requests
  • Prepare and review CMC packages, support GMP submissions
  • Manage change control assessments and ensure compliance with regulatory requirements across multiple regions
  • Conduct and deliver high quality, on time CMC regulatory activities, including compliant management of all internal tools and client systems
  • Author Administrative and CMC regulatory documents/deliverables and collaborate with project SMEs and client stakeholders to prepare submission packages
  • Full management of CMC submissions (i.e. planning, submission package compilation, RtQ preparation, Spontaneous HA queries, etc.)
  • General submission coordination: Submissions planning, create submission binders and Global Content List/Submission Content Plans, coordinate the publishing aspect, review of eCTD sequences
  • Act as main GRA point of contact for LRAs and other stakeholders (i.e. for responding to any queries)
  • Strong organizational and time management skills
  • Coordinate all assigned activities and ensure compliance to all client SOPs/training sessions
  • Strong problem-solving skills
  • Proactive and efficient work ethic
  • Strong oral skills, with proven ability to work efficiently as part of a team
  • Strong interpersonal skills.

Requirements

  • University degree in biological sciences or related health sciences (BS/BA/MS or equivalent, PhD)
  • A degree in Regulatory Affairs is advantageous
  • Minimum of 5 years’ experience in the biotech or pharmaceutical industry
  • At least 5 years in Regulatory Affairs CMC for Senior and 2 for Associate
  • Experience with biological products and Vaccines - Mandatory
  • M3 authoring experience - mandatory
  • Strong technical regulatory expertise and understanding of the regulatory framework in more than one key region (US, EU, Japan, Switzerland, Australia)
  • Regulatory CMC writing skills and able to evaluate technical and scientific CMC information for accuracy and compliance with relevant regulatory requirements - nice to have
  • Knowledge in Good Manufacturing Practice or related areas would be highly regarded.
Benefits
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Applicant Tracking System Keywords

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Hard Skills & Tools
CMC submissionsGMP submissionseCTD sequencesM3 authoringregulatory writingtechnical regulatory expertisebiological productsvaccinesregulatory compliancesubmission package compilation
Soft Skills
organizational skillstime managementproblem-solving skillsproactive work ethicteam collaborationinterpersonal skillscommunication skills
Certifications
degree in biological sciencesdegree in health sciencesdegree in Regulatory Affairs