My client is a multinational pharmaceutical company specialising in patient focused R&D development.
They are looking to onboard a Senior Manager/Associate Director Regulatory Compliance CMC to their dynamic team!!
The role
- The Senior Manager/Associate Director, CMC Regulatory Compliance, is responsible for the strategic and operational activities pertaining to global and local compliance within Global Regulatory Affairs – Chemistry, Manufacturing and Controls (GRA CMC).
- Partners with Global Quality, Global Manufacturing and Supply, Pharmaceutical Sciences, Global Regulatory Operations, Local Operating Companies and other stakeholders for successful CMC regulatory compliance management.
- Develops and manages a program for the tracking, execution, monitoring, and reporting on GRA CMC processes and responsibilities to drive excellence in Regulatory pre and post submission activities.
Main Responsibilities
- Collaborates with Global Regulatory CMC leadership to ensure clear and timely communication about compliance activities and metrics.
- Responsible for alignment with global strategic CMC initiatives related to pre and post submission activities and the processes and systems used to manage compliance.
- Development and leadership of the following activities at a global level in collaboration with relevant partners
- Responsible for compliance-relevant strategic initiative activities which may impact GRA CMC compliance of pre and post submission activities.
- With GRA Compliance and GRA CMC SMEs, as relevant, develops new and updated processes for execution of GRA pre and post submission activities.
- Ensure the company is aligned and responsive to health authority regulations and guidelines as they pertain to applicable regulatory requirements for drugs, biologics, combination products and devices.
- Provides support to Global Quality and other stakeholders for internal and external audits
- Ensures CMC inspection readiness
- Coordinates CMC documentation requests prior to, during and in follow up to inspections/audits
- Supports the development of responses and CAPAs related to GRA CMC for audits/inspections
- Ensures GRA CMC Commitments (i.e. IND, post marketing, PIP) and Quality Events are documented and tracked in the appropriate systems
- Escalate issues/problems to senior management as needed and propose risk-based remediation actions for consideration
- Provides input on budgets for the group as appropriate
- Maintains strong knowledge of current regulations, legislation, best practices and guidelines relating to Regulatory Affairs and GxP.
Requirements
Connect
If you believe that you are the right person for this role, please apply now. Alternatively, if you believe you know somebody in your network who would be suited to this position please forward the details, we offer a competitive referral fee. We also have a presence on LinkedIn and Twitter, or you can sign to our mailing list on our website to be kept up to date with our roles.
Medella Life
As specialist recruiters in life sciences, our mission is to create a positive impact in the world. We place visionary people in thriving cultures where they can create a brighter future. Our impact and what that means to society is why we go the extra mile. We even baked it into our name, Medella, which means to heal. Pairing brilliant scientists with brilliant companies we find wildly exciting, and it drives everything
- Bachelor’s degree (or equivalent) required. Masters preferred.
- 8 plus years’ experience in pharmaceutical industry, with good exposure to Regulatory Affairs, QA, and/or Compliance.
- Familiarity with inspections and audit procedures and able to work with QA leads who host the company’s audits and inspections.
- Strong knowledge of Regulatory business area and interactions and ability to identify the interactions necessary for achieving business goals and objectives
- Ability to identify proactively and anticipate risk of non-compliance in a complex environment
- Demonstrated knowledge of global health authority regulations for pre and post submission activities
- Practical operational experience of working across disciplines and across multiple regions. Experience working within a global team framework and a multi-cultural environment.
- Able to manage both time and priority constraints and to manage multiple priorities simultaneously
- Capability to critically analyze complex and/or ambiguous information and the impact on products and process and to effectively communicate complex issues both verbally and in writing
- Excellent analytical, technical and problem-solving skills (TQM or Six Sigma experience preferred).
- Efficiently/actively manages conflict in a tactful, diplomatic way, seeking effective solutions for all parties.
- Personnel management experience.
- RAPS Regulatory Affairs Certification (RAC) preferred.
Connect
If you believe that you are the right person for this role, please apply now. Alternatively, if you believe you know somebody in your network who would be suited to this position please forward the details, we offer a competitive referral fee. We also have a presence on LinkedIn and Twitter, or you can sign to our mailing list on our website to be kept up to date with our roles.
Medella Life
As specialist recruiters in life sciences, our mission is to create a positive impact in the world. We place visionary people in thriving cultures where they can create a brighter future. Our impact and what that means to society is why we go the extra mile. We even baked it into our name, Medella, which means to heal. Pairing brilliant scientists with brilliant companies we find wildly exciting, and it drives everything