Global Regulatory Affairs Director
4 weeks ago
{"h1": "Associate Director, Global Regulatory Affairs", "p": "At Takeda Pharmaceutical, we are seeking an experienced Associate Director to lead our Global Regulatory Affairs team. As a key member of our organization, you will be responsible for providing strategic guidance on regulatory matters, ensuring compliance with global regulations, and driving the development of high-level regulatory strategies.
Responsibilities:
* Provide global regulatory oversight and execute regulatory activities on late-stage development in multiple indications, device platforms, and cell line changes.
* Lead the development of high-level global regulatory supplemental biologic application strategies and the coordination of global cross-functional submission working groups.
* Collaborate with global regulatory teams to ensure multiple global pre-submission meetings and marketing application submissions.
* Develop and maintain relationships with health authorities, including preparation meetings with FDA, EMA, and PMDA.
* Up to 20% domestic and international travel required.
Requirements:
* Master's degree in Pharmacy, Biomedical Engineering, Regulatory Affairs, or a related field.
* 7 years of related experience, including prior experience as a Global and US Regulatory Strategic Lead.
* Strong knowledge of global regulatory requirements and experience with health authority interactions.
* Excellent leadership and communication skills.
If you are a motivated and experienced professional looking to join a dynamic team, please apply with your resume and a cover letter.
We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.
Apply online at [insert link] and search for Req # R.
Note: This job description is not intended to be an exhaustive list of all responsibilities, skills, or efforts. Other duties, responsibilities, and qualifications may be required and/or assigned.
Takeda is an equal opportunity employer.
We welcome applications from diverse candidates and are committed to creating an inclusive work environment.
If you require accommodations during the application or interview process, please contact us at [insert contact information].
We look forward to hearing from you
Best regards,
[Your Name]"}
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