Senior Manager, Regulatory CMC Clinical Lead

Job Description

About This Role

The Senior Manager, Regulatory CMC Clinical Lead 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

What You’ll Do
  • Provide regional and global strategic and operational regulatory CMC expertise and support in cross-functional teams, as required, and work 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)
  • Write and / or Review regional and global CMC submission documents and responses to Health Authority questions
  • Manage CMC aspects of routine and non-routine regional Health Authority interactions including issue resolution and negotiation of approvals, as delegated.
  • Provide input into regulatory CMC risks assessment and mitigation plans from a regional perspective for assigned regions and ensure that it remains in line with the overall global regulatory CMC strategy.
  • Coordinate and complete regulatory assessments of CMC changes in the designated systems


Who You Are

You have proven leadership and abilities to work cross-functionally and across cultures. You utilize strong communication, regulatory CMC knowledge and interpersonal skills to interact with functional area key stakeholders, both internally and externally, including subject matter experts, partners and regulatory agency personnel.

Qualifications

Regulatory Skills
  • At least 5 years relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity, with at least 3-5 years of experience in Regulatory CMC and preferably 2 years professional experience in pharmaceutical manufacturing, analytical development, and quality assurance/control or related technical field.
  • 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


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.


Preferred/Additional: Recognized experience in project and timeline management. Experience with clinical development and associated regulatory CMC submissions.

Education: BS University degree in Life Sciences, Engineering, Biotechnology, or relevant Pharmaceutical Science; Chemistry background or Graduate degree preferred.



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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