Associate Director, Regulatory Affairs CMC (m/f/t/i)

Job Description

Duties and Responsibilities:
  • Accountable for strategy, planning, definition of content, preparation, review and approval of global regulatory CMC submissions and responses to Health Authority questions.
  • Ensures that the global regulatory CMC strategy for assigned products are consistent with the teams and business goals, missions and objectives and meet Health Authority requirements.
  • Identifies supporting documents required for global submissions and negotiates the delivery of approved technical source documents in accordance with project timelines.
  • Accountable review and approval of CMC submissions and responses to Health Authority questions in line with agreed global regulatory strategy, and within agreed timelines.
  • Leads cross-functional teams responsible for the preparation of submissions and responses to Health Authority CMC questions for assigned projects/products.
  • Ensures effective communication of CMC regulatory strategy, risks, and overall plans to leadership and teams.
  • Highlights and proactively communicates anticipated and ongoing critical Regulatory CMC issues throughout the product lifecycle, in a timely manner, to key stakeholders as appropriate.
  • Facilitates capture and communication (within and outside of Global RegCMC) of CMC lessons learned from major submissions for assigned projects/products.
  • Accountable for all regulatory CMC related interactions, resolution of CMC issues and negotiation of CMC approvals with HAs in all regions.
  • Establishes and maintains modes of effective communication and collaboration with the teams assigned projects/products.
  • Partners with regulatory regional leads for exchange of project/product related information and submission planning.
  • Accountable for the coordination and overall global approval of regulatory assessments for CMC changes.
  • Monitors and influences changes in the global Regulatorily CMC environment in alignment with business needs.
  • Defines and communicates the need for internal and/or external regulatory CMC resource to the Global RegCMC LT as required to deliver CMC submissions for assigned projects/products in all regions to the agreed timelines.
  • Accountable/responsible for the roles and functions of the CMC RRL for the geographical region in which the CMC GRL role is located.
  • Represents Global RegCMC on due diligence and divestment teams as assigned by the Global RegCMC LT.
  • Leads or provides input to Global RegCMC initiatives and cross functional work streams as assigned by Global RegCMC LT.
  • Participates in skill development and coaching of other Global RegCMC Team members as required.
  • Responsible for management, coaching and development of direct reports as applicable.


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 key stakeholders both internally and externally, including subject matter experts, partners and regulatory agency personnel.

Qualifications

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

Regulatory Skills
  • At least 7+ years relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity, with at least 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 leadership in delivering CMC sections of marketing authorizations, clinical trial applications (CTA/IND) and post-approval submissions for new biological, oligonucleotide, and/or chemical entities
  • Broad background of registration experience gained from working in the pharmaceutical industry or a regulatory authority in one or more of the ICH regions.
  • Extensive experience of direct communication and negotiation with regulatory agencies on CMC topics
  • Knowledge of global guidance, regulations and ICH/GMP requirements
  • Demonstrated competence in leading cross-functional teams and operating within a matrix organizational structure


Leadership/Management Skills
  • Ability to work, with accountability, 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.
  • You will apply 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 planning, project management and tracking projects of high complexity and risk with clearly defined critical paths.
  • Pioneer and execute on an agreed global regulatory CMC strategy and ensure that results are in alignment with business priorities.
  • 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.
  • Competence in people development and management.
  • Fluency in English required.


Preferred/Additional: Recognized experience in project and timeline management.



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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