Associate Director, Global Regulatory Affairs CMC
Company: Takeda Pharmaceutical
Posted on: September 20, 2022
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that all information I submit in my employment application is true
to the best of my knowledge. Job Description Are you looking for a
patient-focused, innovation-driven company that will inspire you
and empower you to shine? Join us as an Associate Director, Global
Regulatory Affairs CMC based in Zurich, Switzerland or Vienna,
Austria. Here, you will be a vital contributor to our inspiring,
bold mission. OBJECTIVE:
- Responsible and accountable for regulatory CMC development,
registration and post-approval strategies. RA CMC member on
Regulatory, Pharmaceutical Development, and Commercial project
teams throughout clinical development and commercial lifecycle.
Ensures global strategies are successfully executed across both new
product development and existing portfolio life cycle
- Demonstrates leadership and comprehensive understanding of
global RA CMC regulations and guidelines by applying interpersonal
skills and expert RA CMC knowledge to address and overcome
challenges that arise during development and
- Successfully communicates and negotiates with international
Health Authorities as necessary, directly and indirectly.
- Develops constructive relationships with and proactively
communicates issues to key internal and external colleagues,
including Alliance Partners.
- Provides regulatory CMC expertise for new business
development/due diligence activities.ACCOUNTABILITIES:
- Independently plans, executes and manages regulatory
submissions for assigned compounds in various phases of clinical
development, global marketing applications, and post-approval life
- Member of global cross-functional teams which require
experienced interpretation of applicable EMA/FDA/ICH/WHO/Global
regulations to ensure CMC compliance within the organization.
- Recommends direction for key operations and new initiatives in
collaboration with local and global stakeholders.
- Lead team members that define CMC content (data and
documentation) requirements for regulatory submissions and reviews
this content for conformance with established requirement.
- Manages and develops staff, if required, including staff
professional development and project oversight accountability.
- Represents Takeda RA CMC in Health Authority meetings and leads
preparation activities for meetings with Health Authorities on CMC
- Interacts directly with international Health Authorities, as
required.Participates in and/or facilitates agency meetings.
- Ensures project team colleagues, line management, and key
stakeholders are apprised of developments that may impact
regulatory success, exercising sound judgement and communicating in
a professional and timely manner.Provides solutions to prevent
recurrence of issues.
- Stays abreast of current and evolving regulatory CMC
requirements, applies this knowledge to assigned projects, and
shares knowledge and experience with others to support their
- Develops and maintains constructive relations with key internal
and external colleagues, e.g. cross functional colleagues within
Takeda, Alliance Partners, and Health Authority
- Evaluate new business development opportunities or participate
on due diligence teams
- Proven ability to liaise with Regulatory Agencies, having
served as lead in successful Agency Interactions related to CMC
submissions and product development meetings; international
- Evaluates change proposals for global regulatory impact and
plans global variations and amendments. EDUCATION, BEHAVIOURAL
COMPETENCIES AND SKILLS:
- BS/BA Degree in a Scientific Discipline, Advanced Degree
- 8+ years pharmaceutical Regulatory CMC experience including
experience as an RA CMC product lead, or equivalent industry
- Experience with pharmaceutical development of active
pharmaceutical ingredient/drug substances or drug products,
analytical characterization, process scale-up and/or regulatory
registration of products is required.
- Experience with global regulatory aspects of CMC involving
undefined frameworks with medium technical complexity and defined
scope. Proven ability to liaise with Regulatory Agencies having
served as lead in successful Agency Interactions related to CMC
submissions and product development meetings, international
- Understanding of scientific principles and regulatory CMC
requirements relevant to global drug development and post-market
- Proven ability to provide strategic regulatory guidance to drug
development, registration, and post-market support teams. Provides
regulatory advice and making reasoned decisions on regulatory
issues for which there may not be clear/specific regulatory
- Demonstrates leadership, problem-solving ability, flexibility
and values teamwork.
- Demonstrated ability to work well within a matrix structure in
a complex environment.
- Exercises good judgement in elevating and communicating actual
or potential issues to line management and presents solutions to
- Excellent written and oral communication skills required.
- Active participation in Agency/Industry groups/forums
preferred. WHAT TAKEDA CAN OFFER YOU At Takeda, we are transforming
the pharmaceutical industry through our R&D- driven market
leadership and being a values-led company. To do this, we empower
our people to realize their potential through life-changing work.
Certified as a Global Top Employer, we offer stimulating careers,
encourage innovation, and strive for excellence in everything we
do. We foster an inclusive, collaborative workplace, in which our
global teams are united by an unwavering commitment to deliver
Better Health and a Brighter Future to people around the
world.Empowering Our People to ShineDiscover more at At our heart
are committed colleagues. We offer interested people numerous
opportunities and strongly believe in, and promote, diversity,
equity and inclusion. As a company we offer roles based on merit,
welcoming candidates of any gender, age, religious belief, race or
ethnic origin or disability. Our team is growing and for this we
need bright minds with creativity and flexibility - what talent do
you have? Locations CHE - Glattpark (Opfikon) - Zurich HQAUT - Wien
- DC Tower Worker Type Employee Worker Sub-Type Regular Time Type
Keywords: Takeda Pharmaceutical, Stamford , Associate Director, Global Regulatory Affairs CMC, Executive , Stamford, Connecticut
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