Our Client is currently seeking a Regulatory & Medical Affairs Expert to join their team in Billerica, MA. The selected candidate will be responsible for ensuring compliance with pharmaceutical regulations and laws as well as providing expertise on drug safety and medical topics. Typically reports to a Manager role, Project Manager role for a defined period of time based on organizational set-up (there is not necessarily a difference in role level between a manager and its direct reports – same level or lower level reporting is possible, provided job scope and responsibilities are clearly distinct); typically no direct reports.
- Impact the results within own discipline with own contributions
- Provide input to the technical direction and operational decision making in the field of specialization
- Solve complex problems based on analytical thought and complex judgement
- Accountable for the quality of on-going activities/processes. Works independently and receives minimal guidance
- Contribute to the global CMC regulatory strategy for the assigned products in target regions/countries. This encompasses
responsibility to draft the CMC section of the Regulatory Strategy Document (RSD), risk assessment, strategic support and advice
- Assist senior colleagues for the global CMC strategy and plan for dossiers related to the assigned projects/products, i.e. clinical trial applications, answers to Health Authority queries, life cycle management submissions, marketing authorization applications, briefing documentation for Health Authority interactions
- Provide country specific CMC regulatory requirements for dossier strategies and plans in close collaboration with other GRA functions, including assessment of Change Control Proposals under supervision for their regulatory impact worldwide
- Review study protocols and reports, as well as other relevant technical documents intended for the product documentation
platform or for local submission to confirm alignment of the report conclusions with the CMC Dossier Strategy and Plan
o Confirm alignment between CMC dossier strategy and CMC regulatory documents before approval regarding fit to
strategy, gaps, issues, risks and mitigation measures (within Dossier Generation Team)
o Track submission and approval status to ensure regulatory compliance for all CMC dossier submissions worldwide
- Regulatory intelligence and knowledge management
- Review draft and newly released laws and guidance on behalf of the Company
- Coordinate assessment and implementation of pharmacopeias impacting assigned products, as appropriate
- Support development and execute initiatives to ensure regulatory compliance as required
- Master’s Degree or PhD plus relevant professional experience, and good knowledge and experience in own discipline
- Experience in preparation and management of regulatory documentation, or variations, and life-cycle management activities
- Practical experience in one of the following area for biotech or chemical molecules: manufacturing process development, transfers, validation or analytical development and quality management
- Knowledge of global pharmaceutical legislation
- Excellent written and spoken communication skills in English (knowledge of German language is a plus)
- Good interpersonal skills and flexible mindset, attention to detail, project management skills
- Ability to think strategically and work well in teams
- Awareness of regulatory affairs contribution to Phhe
- Pay ranges from $37 to $41.50 per hour, commensurate with experience
- Optional participation in benefits plan (medical, dental, vision, 401k, etc.)
- 6-month contract with opportunity for extension or direct hire
If your skills match the requirements for this challenging opportunity, please submit your resume today.
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