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Senior Manager, Regulatory CMC Lead

4 months ago

Durham, United States Biogen Full time

About This Role

 
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 antisense oligonucleotide projects working as or working with the Regulatory CMC Lead and key stakeholders, primary contact for affiliates on Regulatory CMC activities in the assigned regions and managing of routine and non-routine Health Authority interactions as delegated. Depending on the stage of development and complexity of the program, this role can be a Regulatory CMC Lead for early-stage development programs or working with the Regulatory CMC Lead for late-stage development or commercial programs. The Regulatory CMC Lead is the primary global contact for Regulatory CMC activities associated with the program and will report to the Regulatory CMC Antisense Oligonucleotide Team Lead.

*This role is a hybrid role and may be based in either Cambridge, MA or RTP, NC locations*

What You’ll Do 
• Providing 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 (including IND/IMPD/CTAs/MAAs)
• Responsible for submission from defining and agreeing content to leading reviews as required to ensure complete, concise and accurate submissions to Health Authorities.
• 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 Health Authority interactions including issue resolution and negotiation of approvals, as delegated.
• Monitoring changes in the Regulatory CMC environment to support and advise key stakeholders and teams
• Providing input into Regulatory CMC risks assessment and mitigation plans 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 Team Lead or Global Regulatory CMC lead, as agreed and delegated and maintaining open lines of communication on assigned projects/products to ensure awareness on status and issues relating to submissions
• Responsible for leading or assisting in delivery of project assignments supporting business needs e.g. representation of Regulatory CMC on cross functional work streams
• Responsible for leading or assisting in delivery of Regulatory CMC initiatives and the development of Regulatory CMC 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

Who You Are 
You love working in a team environment and have a customer-focused mindset. You have experience working in the life sciences industry within a Regulatory CMC role. You have a track record of approaching work with a strategic vision and highly effective in project leadership as well as working with regulatory agencies and other key stakeholders.

Required Skills 

Regulatory Skills
• At least 3-5 years of relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity including 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/or 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/or 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.
• Ability to influence cross-functional stakeholders to ensure execution of optimal RegCMC strategy
• 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.
• 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. Previous oligonucleotide experience (desired but not essential).

Education: Bachelor’s degree in Life Sciences, Engineering, Biotechnology, or relevant pharmaceutical science field; Graduate degree preferred.

Additional Information

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. to learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.