Director, gra cmc pharmaceuticals, oligonucleotides
Company: Takeda Pharmaceutical
Location: Clifton
Posted on: April 19, 2024
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Job Description:
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
with Takeda's Privacy Notice and Terms of Use.I further attest 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 in order to bring life-changing therapies to patients
worldwide.Join Takeda as a Director, GRA CMC Pharmaceuticals,
Oligonucleotides where you will lead the GRA CMC Pharmaceuticals
Oligonucleotide regulatory team in the development and
implementation of global CMC regulatory strategies during
development commercialization and post approval LCM stages. Combine
knowledge of scientific, regulatory and business issues to ensure
the regulatory filings are of high quality and right first time.
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.You will also globally
influence and be generally considered a key opinion leader and
resource within Takeda and externally with stakeholders in HA and
in Industry. Influence 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 meeting
goals/objectives.As part of the GRA CMC Pharmaceuticals,
Oligonucleotides team, you will report to the Executive Director
and Head, CMC Regulatory Affairs, Pharmaceuticals.How you will
contribute: Responsible for demonstrating Takeda leadership
behaviors. Serve as a member of the GRA-CMC Pharmaceuticals
Leadership team, giving input to key strategic, portfolio, human
capital and financial decisions. Provide leadership of GRA CMC
Pharmaceuticals - Oligonucleotides modality, and in conjunction
with direct reports, manages resources, establish a CMC RA strategy
and collaborate with stakeholders in global Reg CMC and across the
enterprise to deliver against them.In conjunction with members of
the team, develop high quality clinical, commercialization and LCM
submissions, using proactive regulatory CMC strategies and submit
them as planned.Build and manage 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.Ensure 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 people.Ensure compliance
with all applicable Takeda SOPs, local and international
regulations, and industry best-practice.Represent, as required, the
regulatory function in the evaluation of new product opportunities
internally and externally.Lead or plays a key role on the relevant
internal Takeda governance committees Minimum
Requirements/Qualifications: BS/BA Degree in a Scientific
Discipline, Advanced Degree preferred.10+ years pharmaceutical
Regulatory CMC experience including experience as an RA CMC product
lead, or equivalent industry experience, with international
experience strongly preferred.Experience liaising with Regulatory
Agencies having served as lead in Agency Interactions and product
development meetings, international experience
preferred.Understanding of scientific principles and regulatory CMC
requirements relevant to global drug development and post-market
support.Experience providing strategic regulatory guidance to drug
development, registration, and post-market support teams.Ability to
deal with issues of critical importance, provides regulatory advice
and making reasoned decisions on regulatory issues for which there
may not be clear/specific regulatory guidance.Demonstrated
leadership, problem-solving ability, flexibility and teamwork.Good
judgement in elevating and communicating actual or potential issues
to line management.Experience of active participation in
Agency/Industry groups/forums expected.What Takeda can offer you:
401(k) with company match and Annual Retirement Contribution Plan
Tuition reimbursement Company match of charitable contributions
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 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: $165,200 - 236,000, 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.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.#LI-RM1 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, East Orange , Director, gra cmc pharmaceuticals, oligonucleotides, Executive , Clifton, New Jersey
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