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Sinead Cullen
Life Science

01 507 9252
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Details

CMC Regulatory Principal Scientist


Reference:SCA013718 Location: Cork
Qualification:DegreeExperience:5-7 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 Regulatory Principal Scientist
Our client, a global pharma company, are currently recruiting for a CMC Regulatory Principal Scientist to join their team on a permanent basis. This is an excellent opportunity to join a global team very strong of regulatory experts. This role offers hybrid working. As CMC Regulatory Principal Scientist, you will lead various aspects of the global marketing authorization submission management processes, help manage submission content for Drug Substance and Drug Product, provide guidance on structure and content placement within CTD registration submissions and provide assistance with submission related Ministry of Health responses.


Responsibilities

  • Provide regulatory support for existing Drug Substances and Drug Products by preparing and maintaining the appropriate regulatory submission documentation needed to obtain & maintain marketing authorizations
  • Partner with CMC Regulatory Scientists to manage outsourcing activities & contract manufacturers
  • Ensure successful preparation of CMC dossiers and variation packages to support product submissions
  • Provide regulatory leadership and support for products listed as the primary responsibilities
  • Develop, plan and execute appropriate regulatory strategies and on agreed-upon priorities through effective partnership with CMC Regulatory Scientists and other functional representatives
  • Prepare CMC CTD content consistent with approved manufacturing changes, technical reports, and procedural requirements
  • Partner with the CMC Regulatory Scientist to plan and prepare submission content for marketed products to support management of post-approval changes for content reuse for the Rest of the World countries
  • Manage submission timelines with relevant teams (e.g. supply chain, QC, manufacturing, clinical teams), monitor approval status and communicate change status to interested personnel in a timely manner
  • Partner with CMC Regulatory Associates to effectively support product lifecycle maintenance such as site registrations, product & site renewals as well as license expiry, where applicable
  • Manage authoring and content reviews of simple RtQs
  • Review/Approve regulatory documents such as: full and core CMC Dossiers , variation packages, post-approval commitments with health authorities and answers to questions received from health authorities

Requirements

  • Minimum degree in Life Sciences, ideally an advanced degree (MSc, PhD, PharmD preferred), in related biological and life science field
  • Regulatory experience in either a pharmaceutical or biotech
  • Knowledge of regulatory and compliance guidelines in pharma/ biopharma
  • Knowledge of Manufacturing & Quality work processes as well as GMP complianceProven ability to effectively influence within a team
  • Communicate effectively, particularly with the view to influencing and developing in an international matrix environment, hereby demonstrating a wider business perspective
  • Displays conscientious attitude, and possesses excellent verbal and written communication skills
  • Fully proficient in RIM and in using common Microsoft applications to create and present work
  • Good organizational skills, with the ability to prioritize and be self-motivating
  • Work well collaboratively within a team, or as an individual contributor
  • Possesses excellent attention to detail and ability to effectively prioritize
  • Proven effective teamwork skills; Able to adapt to diverse interpersonal s

For more information please contact [email protected] or +353879500821