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Manager, Global Regulatory Affairs, Marketed Products

Employer
Takeda
Location
Boston, Massachusetts
Start date
May 24, 2024

View more

Discipline
Regulatory, Regulatory Affairs
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Genetown, Best Places to Work

Job Details

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs, Marketed Products in Cambridge, MA with the following requirements: Bachelor degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology or related field plus 3 years of related experience. Prior experience must include: Vendor and Client Management for Regulatory Operations – Manage relationships with vendors and clients for various regulatory operations services; Identify and evaluate potential eCTD submission vendors based on their experience, expertise, cost-effectiveness, and track record to finalize a suitable vendor; Regulatory Analysis –Analyze the regulatory pathway and history (including competitive regulatory analysis) by researching pre-clinical, clinical, CMC and post-marketing phase for synthetic and botanical drugs; Regulatory submissions to US FDA, EU, Health Canada, and other international health authorities – Support regulatory team and Global Regulatory Lead (GRL) in preparations and timely delivery of detailed and accurate regulatory submissions for drugs, biologics (for US FDA) and Class I-IV devices (for US FDA, Health Canada, EU, and other international agencies) by collaborating with regulatory leads, RPMs, publishers, RIM team, medical writers, and functions SMEs; Regulatory system and business process expertise– Write, develop, and deliver effective regulatory system training programs, work instructions, user guides, SOPs that are tailored to the needs of the regulatory leads and that effectively communicate the regulatory requirements and guidelines in practice. Up to 30% domestic travel required. Up to 70% remote work allowed.

Full time. $165,500 - $186,000/year

Apply on-line at https://jobs.takeda.com and search for Req #R0123885.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Company

Takeda is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions.

For more information, visit https://www.takeda.com.

Stock Symbol: TAK

Company info
Website
Location
650 East Kendall Street
Cambridge
MA
02421
US

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