Oncology Regulatory Affairs Manager
4 days ago
We are seeking an experienced Oncology Regulatory Affairs Manager to join our team at Takeda Pharmaceutical. As a key member of our global regulatory team, you will play a crucial role in ensuring the success of our oncology products through effective regulatory strategy and execution.
In this role, you will be responsible for developing and implementing global regulatory strategies to maximize regulatory success and ensuring compliance with applicable regulations. You will work closely with cross-functional teams to provide guidance and support, maintaining knowledge of changing regulatory requirements and advising teams accordingly.
The estimated salary range for this position is $108,500 - $170,500, based on the location in Boston, MA, and the level of experience required.
Your responsibilities will include:
- Developing and implementing global regulatory strategies to ensure compliance with applicable regulations.
- Providing guidance and support to cross-functional teams to ensure successful development and approval of oncology products.
- Maintaining knowledge of changing regulatory requirements and advising teams accordingly.
- Representing the global regulatory team at project meetings and collaborating with other departments to ensure smooth operations.
To succeed in this role, you should have:
- A Bachelor's Degree in a scientific discipline, with advanced degree preferred.
- A minimum of 2 years of experience in the pharmaceutical industry, with 1 year of regulatory experience or a combination of 2 years of regulatory and/or related experience.
- Preferred experience in reviewing, authoring, or managing components of regulatory submissions.
- Familiarity with drug development processes and regulatory requirements.
- Excellent communication and interpersonal skills, with ability to work effectively in a team environment.
We offer a comprehensive benefits package, including medical, dental, vision insurance, a 401(k) plan, short-term and long-term disability coverage, basic life insurance, tuition reimbursement, paid volunteer time off, company holidays, and well-being benefits.
Takeda is an equal opportunities employer, committed to diversity and inclusion. If you share our passion for making a difference in patients' lives, please apply now
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