Strategist, Global Regulatory Affairs CMC
vor 2 Wochen
We are seeking a highly motivated and qualified regulatory CMC professional to join our Global Regulatory Affairs CMC & Device organization in the Plasma-Derived Therapies Business Unit (PDT BU) at Takeda.
Key Responsibilities:- Defining, coordinating, and implementing global CMC regulatory strategies for product-specific development and life-cycle activities.
- Providing proactive strategic guidance to the product-specific global regulatory and manufacturing sub-teams for defining global regulatory CMC strategies and objectives.
- Liaising directly with the US FDA and with local regulatory teams for discussions with international health authorities and agencies for CMC-related matters.
- Negotiating with regulatory authorities during the development process to ensure submission acceptance and approval.
- Managing the CMC regulatory strategy of high-quality and compliant regulatory CMC documentation for the assigned product(s) within defined timelines.
- Advising on regulatory strategies, solutions to scientific problems, and interpretation of results in the context of product registration requirements.
- Facilitating the communication and flow of regulatory information to all relevant stakeholders.
- Identifying and recommending the most effective CMC regulatory strategies to assure a first-pass regulatory approval of initial application and lifecycle supplements/variations.
- Proactively contributing to the development and implementation of innovative CMC regulatory strategies in close collaboration with relevant stakeholders or functions.
- Bachelor's degree in a scientific discipline (advanced degree preferred).
- 5+ years of biotechnology/pharmaceutical industry experience.
- 3+ years of regulatory CMC experience (biologics or plasma preferred).
- Demonstrated ability to collaborate within teams and with key cross-functional areas.
- Demonstrated experience in authoring and managing components of regulatory submissions.
- Good knowledge of global regulatory CMC requirements and experience with interactions/negotiations with global health authorities.
- Strong oral and written communication and negotiation skills.
- A competitive remuneration package with a minimum salary of € 5.538,85 - gross per month (full-time, collective wage agreement for the chemical industry).
- Support with parental leave, dad month, bilingual company kindergarten.
- Comprehensive training programs.
- In-house job rotation program.
- In-house canteen with discounts or meal vouchers.
- Works council (events, festivals, shopping vouchers, etc.).
- Employee Referral Program.
- Employee Recognition Program.
- Takeda Resource Groups.
- Medical checkups.
- Free vaccination program.
- Fitness Center.
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