Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Senior Manager, Global Regulatory Affairs CMC - Biologics in our Brooklyn Park, Minnesota office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Manager, Global Regulatory Affairs CMC - Biologics working on the Global Regulatory Affairs team, you will be empowered to be innovative and collaborative, and a typical day will include: POSITION OBJECTIVES:
- Supports the development and executes the registration and post-approval strategies, in support of the Regulatory, Pharmaceutical Development, and Production project teams for assigned products throughout Product lifecycle
- Develops a solid understanding of global RA CMC regulations and guidelines, and participates in the development of strategies to enhance probability of regulatory success or enhancing regulatory compliance
- Interacts and effectively communicates with other internal and external colleagues, as well as with other functional areas and Alliance Partners.
- Provides ongoing support for commercial manufacturing operations assessing process changes and conducting annual reviews. Provides support and guidance for site regulatory enabling activities such as process validation, analytical technical transfer, stability programs and the regulatory strategy to ensure these activities will adequately support site registration globally.
Qualifications: EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Assists in authoring regulatory submissions from a site perspective and supports planning and execution of global submissions for assigned projects with appropriate supervision from GRA CMC Management.
- Helps define CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirements, with appropriate oversight of RA CMC Management.
- Ensures line management is apprised of developments that may impact regulatory success, communicating in a professional and timely manner
- Evaluates change proposals for global regulatory impact and helps plan variations and amendments.
- BS/BA Degree in a Scientific Discipline, Advanced Degree preferred
- 7 + years pharmaceutical Regulatory CMC experience in a supportive role, or equivalent industry experience (e.g. Pharmaceutical Development, Analytical Development, Production, Quality Assurance) desired
- Ability to understand, apply, and articulate regulatory CMC requirements for global drug development and post-market support initiatives required.
- Demonstrates attention to detail, problem-solving abilities, and exercises appropriate judgment when working with project teams
- Exercises good judgment in elevating and communicating actual or potential issues to line management.
- Excellent written and oral communication skills required. Works well in teams
TRAVEL REQUIREMENTS: WHAT TAKEDA CAN OFFER YOU:
- RAC certification desirable but not mandatory
Empowering Our People to Shine
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement
- Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs
Learn more at takedajobs.com
Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx
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A little about us:
Takeda fosters an inclusive environment where all employees are empowered to shine.