Manager, Regulatory Affairs CMC

Job Description

This role is responsible for regulatory CMC expertise into the development and implementation of the global regulatory strategy, operations and planning for the CMC aspects of assigned projects/products. Responsibilities include preparation and compilation of submission/documentation for specific small molecules projects, working as or working with the 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. Depending on the stage of development and complexity of the program, this role can be an CMC Global Regulatory Lead for early stage development programs or working with the CMC Global Regulatory Lead for late stage development programs.

For early stage programs, the Regulatory CMC Clinical lead is the primary global contact for regulatory CMC activities associated with the program. For late stage development programs the Regulatory CMC Clinical lead is the primary contact in the assigned regions (US, Canada, Latin America where located in the USA and EU, MENA, APAC where located in the Europe).

This candidate must have proven leadership and abilities to work cross-functionally and across cultures. Strong communication, regulatory CMC knowledge and interpersonal skills are required.

Duties and Responsibilities:
  • Providing regional and global 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 (IND/IMPD/CTAs)
  • 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
  • Responsible for assuming responsibilities from the global regulatory lead, as agreed and delegated and maintaining open lines of communication with the lead on assigned projects/products to ensure awareness on status and issues relating to regional submissions.
  • Responsible for leading or assisting in delivery of project assignments supporting business needs e.g. representation of RegCMC on cross functional work streams
  • Responsible for leading or assisting in delivery of RegCMC initiatives and the development of RegCMC standards and SOPs, as assigned.
  • Ensure that appropriate records are maintained in the designated system for submission in assigned regions

Key Contacts and Interactions: Ethically interacts with multiple international, cross-functional departments, industry peers and health authority contacts at all levels.

Customer focused: Interacts with a functional area key stakeholder both internally and externally, including subject matter experts, partners and regulatory agency personnel.

Qualifications

Required Skills
  • BS degree in Life Sciences, Engineering, Biotechnology, or relevant Pharmaceutical Science
  • Minimum of 3 years of related experience (pharmaceutical or biotech is desired), ideally in global regulatory CMC

Preferred Skills:
  • Graduate degree
  • Recognized experience in project and timeline management.
  • Experience with clinical development and associated regulatory CMC submissions (IND/IMPD/CTAs).
  • Small molecule experience preferred.

Preferred Regulatory Skills:
  • Successful authoring and contribution to delivering CMC submission documents of development and marketed products (biological, oligonucleotide, and/or chemical entities)
  • Broad background of registration experience gained from working in the pharmaceutical industry or a regulatory authority in one of the ICH regions on development and post-approval products
  • Experience of direct communication and negotiation with regulatory agencies on CMC matters
  • 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

Preferred Leadership/Management Skills:
  • Ability to work, with responsibility, both independently and within project teams or committees to attain group goals and key project milestones.
  • Demonstrated inclusive leadership and emotional intelligence, along with verbal and written remote working communication abilities.
  • Demonstrated strategic thinking, change champion leadership, and risk assessment, including ability to integrate overall business objectives into the goals/vision/values of department and to communicate these effectively.
  • Demonstrated competency in operations, planning, project management and tracking projects of high complexity and risk with clearly defined critical paths.
  • Proven ability to manage projects across global locations/time zones. Proven ability to create strong, productive working relationships in a global setting with many different cultures.
  • Enthusiastic orientation to teamwork. Works inclusively and collaboratively, effectively and efficiently with others internally and externally. Strong conflict resolution skills: proven abilities to effectively and expeditiously reach satisfactory resolution among all involved parties.




Additional Information

Biogen’s US Alzheimer’s Franchise is looking to recruit proven and ambitious sales achievers with at least five years of experience in pharma, specialty, hospital, med device/capital equipment, and/or biotech sales.
In this field-based, specialty sales representative position you will be called upon to sell our products with key stakeholders in the Alzheimer’s Disease community: including Neurologists and allied health professionals.

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