Senior Manager/Associate Director Global Regulatory Strategy
Company: Takeda Pharmaceutical
Location: Cherry Hill
Posted on: March 14, 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 About the role: 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 Senior Manager/Associate Director
Regulatory Strategy. Here, everyone matters and you will be a vital
contributor to our inspiring, bold mission. As a Senior
Manager/Associate Director Regulatory Strategy working on the
Neuroscience Global Regulatory Affairs team, you will be
responsible for complex or highly complex or multiple projects and
lead the Global Regulatory Teams (GRTs) , and a typical day will
- Oversees as well as executes all regulatory activities of
multiple projects in development
- 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 responsibility.Join
Takeda as a Senior Manager/Associate Director Regulatory Strategy
working on the Neuroscience Global Regulatory Affairs team, based
in Cambridge, MA. How you will contribute: ACCOUNTABILITIES
- Responsible for achieving submission of INDs, CTAs,
NDA/BLA/MAA, briefing packages, responses, and other
- Accountable for ensuring all other regulatory submissions
within the non-US "Americas" territories are submitted on schedule
by local Takeda affiliates or development partners and CROs .
- 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
- Identifies regulatory requirements and provides regulatory
guidance, and expertise to global development team on the assigned
project(s) of responsibility.
- Proactively anticipates risks and responsible for developing
solutions to identified risks and discussing with team and
management; understands probabilities of technical success for the
- Assists and attends/.leads (when applicable) FDA and other
- Leads regulatory reviews for licensing opportunities.
- Participates in departmental and cross-functional task-forces
- Identifies and notifies management of any resource gaps for
- Provides oversight to ensure regulatory compliance.
- Present to senior management as requested.Minimum
- BSc Degree preferred.
- 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 objectives.What
Takeda can offer you:
- Comprehensive Healthcare: Medical, Dental, and Vision
- Financial Planning & Stability: 401(k) with company match and
Annual Retirement Contribution Plan
- Health & Wellness programs including onsite flu shots and
- Generous time off for vacation and the option to purchase
additional vacation days
- Community Outreach Programs and company match of charitable
- Family Planning Support
- Flexible Work Paths
- Tuition reimbursementMore about us:At Takeda, we are
transforming patient care through the development of novel
specialty pharmaceuticals and best in class patient support
programs. Takeda is a patient-focused company that will inspire and
empower you to grow through life-changing work.Certified as a
Global Top Employer, Takeda offers stimulating careers, encourages
innovation, and strives for excellence in everything we do. We
foster an inclusive, collaborative workplace, in which our teams
are united by an unwavering commitment to deliver Better Health and
a Brighter Future to people around the world. LOCATION:
- The role can be hybrid or at our Cambridge, MA officeIn
accordance with the CO Equal Pay Act, Colorado Applicants Are Not
Permitted to Apply.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, Cherry Hill , Senior Manager/Associate Director Global Regulatory Strategy, Executive , Cherry Hill, New Jersey
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