Sr. Manager/ Associate Director GRA Marketed Products Growth and Emerging Markets Regulatory Lead
Company: Takeda Pharmaceutical
Location: Cherry Hill
Posted on: January 16, 2023
Job Description:
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Job Description
About the role:
At Takeda, we are a forward-looking, world-class R&D
organization that unlocks innovation and delivers transformative
therapies to patients. By focusing R&D efforts on four
therapeutic areas and other targeted investments, we push the
boundaries of what is possible in order to bring life-changing
therapies to patients worldwide.
Join Takeda as an Associate Director GRA Marketed Products Growth
and Emerging Markets Regulatory Lead
How you will contribute:
- Responsible for demonstrating Takeda leadership behaviors
- Defines, develops and leads Marketed Products GEM strategies to
maximize regulatory success towards
- achievement of program objectives in collaboration with Global
and Local teams
- Independently manages, plans and executes all aspects for the
successful preparation, submission and
- Timely approval of investigational applications, market
applications, variations, post approval reporting
- Obligations and general product life cycle management of
assigned program
- Represents Takeda MPG GEM in Health Authority meetings and
leads or supports preparation activities for
- Meetings with HA , as required . Interacts directly with HA and
participates in agency meetings and may
- Facilitate, depending on experience, for assigned programs
- Works closely with functional areas throughout the company.
Advises functional areas regarding content
- requirements for MPG GEM submissions, reviews documents from
functional contributors for consistency
- and completeness
- Stays current with regulations / guidances in Growth and
Emerging Markets for impact on drug develop ment plans,
registration and life-cycle management to maximize the positive
outcomes of the regulatory applications and maintain registration
compliance
- In coordination with local regulatory lead, provides strategic
guidance / advice on regulatory trends, regulations and changes,
with emphasis on those related to assigned program enabling
proactive approach and planning to future business needs
- Provides regulatory expertise on Marketed Products GEM for
multiple projects including at least one highly complex program,
focused on non-clinical and clinical aspects of registration and /
or post-marketing compliance and life cycle management
- Assures ongoing efforts towards fulfilment of international
product approval conditions for late-stage programs
- Develops effective working relationships with Local Regulatory
Lead, Regional and Global Regulatory Team, Cross-functional Teams;
company's consultants and Business Partners
- Supports Access to Medicines initiatives to develop and
implement innovative patient access strategies
- Evaluates new business development opportunities for Growth and
Emerging Markets and / or participates on due diligence teams
- Mentors other team members, if required, to support scope of
project work
Willingness to travel to various meetings, including overnight
trips
Requires approximately 10-30 % travel
Minimum Requirements/Qualifications:
- Bachelor's degree in a scientific discipline; BA accepted based
on experience. Advance degree preferred.
- Considerable experience within the pharmaceutical industry and
including direct experience in regulatory affairs in development
and/or post-marketing phases
- 8 years of directly-related regulatory experience is
desirable
- Sound working knowledge of regulations and guidances governing
drugs and biologics in development and life-cycle management for
growth and emerging markets; and US and EU (relevant to role),
including interaction with Health Authorities
- Generally strong in most and acceptable in all basic skill sets
such as oral and written communications, managing and adhering to
timelines, negotiation skills, integrity and adaptability
- Able to demonstrate skill(s) in regulatory strategy such as
understanding broad concepts within regultory affairs and
implications across the organization and globally; proactively
identifies regulatory issues; offers creative solutions and
strategies, including risk mitigation strategies
- Generally strong in working well with others and within global
teams
- Effective manager who is able to bring working teams together
for common objectives
- Experience managing relationships with CROs and/or contractors
is also preferred
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
health screenings
- Generous time off for vacation and the option to purchase
additional vacation days
- Community Outreach Programs and company match of charitable
contributions
- Family Planning Support
- Flexible Work Paths
- Tuition reimbursement Base Salary Range: $124,600 to $178,000,
based on candidate professional experience level. Employees may
also be eligible for Short-term and Long-Term Incentive benefits as
well. Employees are eligible to participate in Medical, Dental,
Vision, Life Insurance, 401(k), Charitable Contribution Match,
Holidays, Personal Days & Vacation, Tuition Reimbursement Program
and Paid Volunteer Time Off. This posting is made in compliance
with Colorado's Equal Pay for Equal Work Act, C.R.S. 8-5-101 et
seq
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
Massachusetts - Virtual
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Keywords: Takeda Pharmaceutical, Cherry Hill , Sr. Manager/ Associate Director GRA Marketed Products Growth and Emerging Markets Regulatory Lead , Executive , Cherry Hill, New Jersey
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