Posted in Information Technology 12 days ago.
Type: Full Time
Job Description
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.
What You'll Do
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
Leadership/Management Skills
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. Read on 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.
PDN-9be183c1-09d8-4da6-943d-bac85fd35ad7
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