Associate Director, Global Regulatory Affairs CMC - Cell and Gene Therapy
Company: Takeda Pharmaceuticals International GmbH
Posted on: January 10, 2021
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other employers. See below or here for more info. Associate
Director, Global Regulatory Affairs CMC - Cell and Gene Therapy
Takeda fosters a collaborative and stimulating work environment
filled with opportunity and the chance to make a difference in
people's lives. It is a workplace driven by integrity, one of
Takeda's long-held values that extends to both the patients we
serve and our employees who develop and deliver medicines. Across
our company, Takeda employees bring together diverse strengths that
together create a stronger whole. As one of the world's leading
biopharmaceutical companies, Takeda is committed to bringing Better
Health and a Brighter future to people worldwide. We aspire to
bring our leadership in translating science into life-changing
medicines to the next level, in our core focus areas; oncology,
gastroenterology, neuroscience, rare diseases, plasma-derived
therapies, and vaccines. The Greater Boston Area is headquarters to
many of our Global and US business units. We are a passionate team
doing important work that impacts patients' lives. If you are
driven to create better health and a brighter future, join us!
Success What makes a successful member of our team? Check out the
traits we're looking for and see if you have the right mix. Life at
Takeda A Global Top Employer Recognized for our culture and way of
working, we're one of only select companies to receive Top Global
Employer -- status for 2020. Associate Director, Global Regulatory
Affairs CMC - Cell and Gene Therapy Job ID R0023155 Date posted
10/26/2020 Location Boston, Massachusetts Are you looking for a
patient-focused company that will inspire you and support your
career? If so, be empowered to take charge of your future at
Takeda. Join us as an Associate Director, Global Regulatory Affairs
CMC in our Cambridge office. Here, everyone matters and you will be
a vital contributor to our inspiring, bold mission. As an Associate
Director working on the Global Regulatory Affairs CMC team, you
will be responsible and accountable for regulatory CMC development,
registration and post-approval strategies, and a typical day will
- 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 management.
- 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
- 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 (e.g., Pharmaceutical Development, Analytical
Development, Production, Quality Assurance).
- 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.
- Proven global regulatory experience in the area of cell and
gene therapy a must
- 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. PHYSICAL DEMANDS:
- Routine demands of an office based environment.
- Manual dexterity required to operate office equipment (i.e.
computers, phones, etc.).
- Carrying, handling and reaching for objects.
- Ability to sit or stand for long periods of time while
traveling. TRAVEL REQUIREMENTS:
- Requires approximately up to 10-30% travel.
- Willingness to travel to various meetings, including overnight
trips. *expectation for travel may depend on the projects to be
supported WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution
- Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and
- Generous time off for vacation and the option to purchase
additional vacation days Check out where you could be
working if you apply. Job Seekers: Protect yourself against
identity theft Please be aware there are instances of identity
thieves posting Takeda-branded jobs and posing as employees to
steal personal information. They visit job-related websites and
invite candidates to online chats. During the chat, they press job
seekers to provide bank account information and Social Security
numbers. Copyright 1995-2019 Takeda Pharmaceutical Company Limited.
All rights reserved.
Keywords: Takeda Pharmaceuticals International GmbH, Cambridge , Associate Director, Global Regulatory Affairs CMC - Cell and Gene Therapy, Executive , Cambridge, Massachusetts
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