Senior Manager, Global Regulatory CMC

☞ Biogen

View: 209

Update day: 21-03-2024

Location: Baar Zug ZG

Category: Legal / Contracts R & D Science Labor

Industry: Research Services Biotechnology Research Pharmaceutical Manufacturing

Position: Mid-Senior level

Job type: Full-time

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Job content

What You’ll Do

Job Description
  • Providing regional strategic and operational regulatory CMC expertise and support in cross-functional teams, as required, and working flexibly within and across regions to provide broad operational support to ensure the delivery of project/products and business objectives.
  • Preparation and delivery of CMC regulatory operational plans for products in the assigned regions and supporting the preparation and delivery of regulatory submissions.
  • Responsible for regional submission from defining and agreeing content with CMC global regulatory lead to leading reviews as required to ensure complete, concise, and accurate submissions to Health Authorities in assigned regions.
  • Writing and /or Review of regional and global CMC submission documents and responses to Health Authority questions
  • Managing CMC aspects of routine and non-routine regional Health Authority interactions including issue resolution and negotiation of approvals, as delegated.
  • Monitoring changes in the regulatory CMC environment in assigned regions to support and advise CMC global lead and teams.
  • Providing input into regulatory CMC risks assessment and mitigation plans from a regional perspective for assigned regions and ensuring that it remains in line with the overall global regulatory CMC strategy.
  • Coordinating and completing regulatory assessments of CMC changes in the designated systems
Who You Are

Qualifications

In addition to your regulatory leadership experience, you have successfully worked in a matrix environment where you collaborated with global teams within the organization. You have strong communication and project management skills.

Required Skills
  • A Bachelor’s degree in Life Sciences, Engineering, Biotechnology, or relevant Pharmaceutical Science.
  • 3-5 years relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity, with at least 3 years of experience in Regulatory CMC and preferably 2 years professional experience in pharmaceutical manufacturing, analytical development, or quality assurance/control or related technical field.
  • Successful authoring and contribution to delivering CMC submission documents of development and marketed products (biotherapeutical orginators and biosimilar products)
  • Broad background of clinical trial submissions and registration experience gained from working in the pharmaceutical industry or a regulatory authority in one of the ICH regions.
  • Experience of direct communication and negotiation with regulatory agencies on CMC matters is a plus.
  • Knowledge of GMP requirements and standard systems (e.g. change management systems).
  • Demonstrated competence in leading cross-functional teams and operating within a matrix organizational structure.
  • Demonstrated inclusive leadership and emotional intelligence, along with verbal and written remote working communication abilities.
Additional Information

As the Sr. Manager CMC Regional Regulatory Lead (CMC RRL), you are responsible for regional regulatory expertise into the development and implementation of the global regulatory strategy, operations, and planning for the CMC aspects of assigned projects/products. Your responsibilities include preparation and compilation of submission/documentation for biosimilar projects, working with CMC Global Regulatory Lead and key stakeholders, primary contact for affiliates on regulatory CMC activities in the assigned regions and managing of routine and non-routine regional Health Authority interactions as delegated by the CMC global regulatory lead. As the CMC RRL you are also the primary contact for affiliates on regulatory CMC activities in the assigned regions.
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Deadline: 05-05-2024

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