Executive Director and Head, CMC Regulatory Affairs - Pharmaceuticals
Company: Takeda Pharmaceutical
Posted on: May 26, 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: 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 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 the development and commercial
- Combines the 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 the 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
the key strategic, portfolio, human capital, and financial
- Provides leadership of GRA CMC Pharmaceuticals regulatory team
and in conjunction with direct reports, manages resources,
establishes a vision, and collaborates with stakeholders in global
Reg CMC and across the enterprise to deliver against them.
- In conjunction 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's position and influence the
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 organizations
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 Ph.D. 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
- 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 a 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 world.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 the candidate's 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.The final salary offered for this
position may take into account a number of factors including, but
not limited to, location, skills, education, and experienceIn
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, Newark , Executive Director and Head, CMC Regulatory Affairs - Pharmaceuticals, Healthcare , Newark, New Jersey
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