Executive Director and Head, CMC Regulatory Affairs - Pharmaceuticals
Company: Takeda Pharmaceutical
Location: Cherry Hill
Posted on: January 15, 2023
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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.
How you will contribute:
- Leads the chemical/synthetic molecule CMC regulatory team in
the development and implementation of global CMC regulatory
strategies for products throughout development and commercial
- Combines knowledge of scientific, regulatory and business
issues to ensure the registration and life cycle maintenance (CMC
regulatory aspects) of products are of high quality and right first
- Maintain up-to-date knowledge and expertise of relevant CMC and
quality guidelines and regulations and establishes mechanisms to
communicate them to relevant stakeholders, thereby driving
prospective and proactive implementation.
- Globally influences and is generally considered a key opinion
leader and resource within Takeda and externally with stakeholders
in HA and in Industry.
- Influences changing regulations and guidance documents;
interfaces with outside regulatory agencies and trade associations
and acts as an advisor/liaison to senior management to plan,
evaluate and recommend implementation strategy.
- Establish collaboration with Global CMC teams and leadership
through networks and enable CMC regulatory team's success in
- Responsible for demonstrating Takeda leadership behaviors.
Serve as a member of the GRA-CMC Leadership team, giving input to
key strategic, portfolio, human capital and financial
- Provides leadership of GRA CMC Pharmaceuticals regulatory team
and in conjunction with direct reports, manages resources,
establish a vision, and collaborate with stakeholders in global Reg
CMC and across the enterprise to deliver against them.
- Inconjunction with members of the team, develop as well as
oversee development (including updates) and communication of
proactive regulatory CMC strategies to global CMC regulatory teams
and stakeholders in a timely manner
- Builds and manages relationships through active partnering with
key internal (GRA, GRA CMC, Pharmaceutical Sciences, GMS, GQ etc.)
and external stakeholders (Health authorities, Industry
counterparts/associations, academia). Relationship management and
constructive partnering with Health Authorities and relevant
industry organizations to drive Takeda position and influence
scientific approach and thought process to CMC topics.
- Ensures team effectiveness in working across a very complex
matrix environment in GRA with CMC RA project leads and other GRA
sub-functions, as needed to ensure effective strategies are
developed and project execution is on target.
- Build and maintain communication strategy and platform for all
staff across the organization. Responsible for timely dissemination
of regulations, guidelines and data to staff and stakeholders via
team sites or intranet. Actively engage and influence organization
to think proactively and utilize science and risk based approach to
product development and LCM activities.
- Contribute to creating and communicating an employment culture
and values which attract, retain, and develop the most effective
- Ensure compliance with all applicable Takeda SOPs, local and
international regulations, and industry best-practice.
- Represents, as required, the regulatory function in the
evaluation of new product opportunities internally and
- Leads or plays a key role on the relevant internal Takeda
governance committees Minimum Requirements/Qualifications:
- Advanced Degree or PhD in Life Sciences, Pharmacy or Medicines,
or related discipline.
- Languages: Fluent in English (oral and written); additional
- Minimum of 20 years of experience within regulatory agencies or
the Pharmaceutical Industry including significant leadership
experience in Regulatory Sciences
- Significant understanding and track record in dealing with
international regulations and policies setting processes of major
regulatory agencies (e.g. US FDA, EU, PMDA, NMPA, WHO).
- Actively engaged in major industry associations (e.g. EFPIA,
BIO, PhRMA, CASSS, PDA, ISPE, DIA) and joint regulator/industry
initiatives (e.g. ICH).
- Strong communication, collaboration, negotiation, problem
solving and interpersonal skills. Has a proven track record of
working across regulator/industry boundaries to find common
solutions and drive positive impact and benefits for patients.
- High organization awareness (e.g. interrelationship of
departments, business priorities), including significant experience
working cross-functionally and in teams. 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 Community Outreach Programs and company match
of charitable contributions
- Family Planning Support
- Flexible Work Paths
- Tuition reimbursement More 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
This position is currently classified as "hybrid" in accordance
with Takeda's Hybrid and Remote Work policy.
Base Salary Range: $193,200- $276,000, 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
The final salary offered for this position may take into account a
number of factors including, but not limited to, location, skills,
education, and experience
In accordance with the CO Equal Pay Act, Colorado Applicants Are
Not Permitted to Apply.
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.
Keywords: Takeda Pharmaceutical, Cherry Hill , Executive Director and Head, CMC Regulatory Affairs - Pharmaceuticals, Executive , Cherry Hill, New Jersey
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