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Director of Regulatory Strategy
vor 2 Wochen
Job Description:
This is an exciting opportunity to join Takeda as a Director of Regulatory Strategy - EUCAN. As a member of our Regulatory Affairs team, you will be responsible for leading the development and implementation of regional regulatory strategies to ensure compliance with regulations and guidelines.
Main Responsibilities:
- Develops and implements regional regulatory strategies to achieve regulatory success.
- Liaises with health authorities in the region, representing Takeda as required.
- Maintains relationships with external stakeholders, including regulatory agencies, industry organizations, and experts.
- Oversees regulatory submissions and approvals, ensuring they are achieved on schedule within area of responsibility.
- Collaborates with cross-functional teams to ensure regulatory requirements are met throughout product development and lifecycle.
About You:
We are looking for a highly experienced individual with a strong background in drug regulatory affairs, preferably within the EU/GEM region. You should have a minimum of 8 years of experience and a solid understanding of regulations and guidance applicable in the region across all phases of development.
Requirements:
- BSc or Advanced scientific related degree preferred; BA accepted based on experience.
- Solid regulatory experience, including knowledge of regulations and guidance applicable in the region.
- Ability to formulate regional regulatory strategy to achieve competitive and accelerated product approvals.
- Able to manage different types of regulatory development or lifecycle management procedures in the region.
- Excellent communication and interpersonal skills, with the ability to build effective working relationships with internal and external stakeholders.
