Manager/Senior Manager, Global Regulatory Affairs - Oncology
Company: Takeda Pharmaceutical
Posted on: March 19, 2023
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
that all information I submit in my employment application is true
to the best of my knowledge. Job Description Are you looking for a
patient-focused company that will inspire you and support your
career? If so, be empowered to take charge of your future at
Takeda. Join us as a Manager/Senior Manager, Global Regulatory
Affairs - Oncology in our Cambridge, MA office. OBJECTIVES:
- Oversees as well as executes all regulatory activities of
multiple projects including one highly complex project in
development and/or supports regulatory activities for assigned
marketed product(s) of responsibility.
- Provides a regulatory strategic focus on non-clinical and
clinical aspects of drug development and associated
- May serve as global regulatory lead (GRL) on the global project
team (GPT) for individual project(s) of responsibility
- Collaborates with all Takeda regions to ensure a global
regulatory strategy is created and executed upon for all projects
within area of responsibility.
- May be primary FDA contact for projects of
- Responsible for achieving submission of INDs, CTAs, briefing
packages, responses, and other submissions. Major submissions
(NDA/BLA/MAA) under oversight of manager.
- Accountable for ensuring all other regulatory submissions
within the non-US "Americas" territories are submitted on schedule
by local Takeda affiliates or development partners (eg, PRA or
co-development partners) within project(s) of responsibility by
ensuring the regulatory deliverables are provided as outlined in
the global regulatory strategy.
- May develop/author or assist Global Regulatory Lead with
development of global regulatory strategy.
- For the project(s) of responsibility, collaborates with EU
and/or other regional counterparts in the authoring of global
regulatory strategies and ensures critical deliverables to
territories outside the US to ensure regional execution of the
strategy as agreed within the global regulatory strategy
- Executes day-to-day activities for projects or delegates to
staff with oversight.
- Identifies regulatory requirements and provides regulatory
guidance, and expertise to global development team on the assigned
project(s) of responsibility.
- Assists and attends FDA and other agency meetings.
- Identifies and notifies management of any resource gaps for
- Provides oversight to ensure regulatory compliance of marketed
- Present to senior management as requested.EDUCATION,
EXPERIENCE, KNOWLEDGE AND SKILLS:
- BSc Degree preferred. BA accepted.
- A minimum of 4 years of pharmaceutical industry experience.
This is inclusive of 3 years of regulatory experience or
combination of 4 years regulatory and/or related experience.
- Preferred experience in reviewing, authoring, or managing
components of regulatory submissions.
- Working knowledge of drug development process and regulatory
- Understands and interprets scientific data as it relates to
regulatory requirements and strategy for assigned projects.
- Demonstrates acceptable skills in oral and written
communications, managing and adhering to timelines, negotiation
skills, integrity and adaptability.
- Demonstrates acceptable skills with increasing independence in
the area of regulatory strategy such as understanding broad
concepts within regulatory affairs and implications across the
organization and globally; proactively identifies regulatory
issues; offers creative solutions and strategies, including risk
- Must work well with others and within global teams.
- Able to bring working teams together for common
- Willingness to travel to various meetings or client sites
including overnight trips. Some international travel may be
- Requires approximately 10 % travel.EEO Statement Takeda is
proud in its commitment to creating a diverse workforce and
providing equal employment opportunities to all employees and
applicants for employment without regard to race, color, religion,
sex, sexual orientation, gender identity, gender expression,
parental status, national origin, age, disability, citizenship
status, genetic information or characteristics, marital status,
status as a Vietnam era veteran, special disabled veteran, or other
protected veteran in accordance with applicable federal, state and
local laws, and any other characteristic protected by law.
Locations Boston, MA Worker Type Employee Worker Sub-Type Regular
Time Type Full time
Keywords: Takeda Pharmaceutical, Rochester , Manager/Senior Manager, Global Regulatory Affairs - Oncology, Executive , Rochester, New York
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