Associate Director, Global Regulatory Affairs, Advertising and Promotion- REMOTE
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.
- The Lead International Advertising and Promotion (A&P)
serves as an internal expert on International, EFPIA, and
regulations, guidance governing the promotion of prescription drug
and biologic products and disease awareness activities.
- The Lead International Advertising and Promotion (A&P)
serves as the reviewer for pipeline compounds and as such must have
an understanding of the EphMRA Code governing market research
- Capable of providing regulatory strategic oversight for at
least one (1) complex product or therapeutic area/multiple products
to help ensure regulatory compliance of promotional and
non-promotional materials generated for assigned products and/or
- Assists in the development, integration, and implementation of
internal policies, work instructions, guidances and regional and
LOC specific requirements, in collaboration with the A&P Group
- The role serves as the process expert and is the lead for
applicable A&P projects to ensure collaboration with key
stakeholders and completion as planned.
- Works collaboratively with colleagues in Regulatory Affairs,
Medical, Legal, Commercial and Ethics & Compliance organizations
and applies expertise to ensure that the development of promotional
and disease state materials is accomplished through compliance with
internal processes and standards.
- Responsible for selected LOC's in a designated region to
support the strategy and integration and implementation of the
Local review process variations, working instructions and assist in
local complaint management in order to ensure consistency with the
- Supports the development, integration and implementation of
directed and agreed future development and improvement of the
global review process, standards .
- Evaluates materials to ensure compliance with International
regulations, guidance, corporate standards and policies and
business objectives. In collaboration with Commercial, Medical and
Legal colleagues, conducts a detailed review and evaluation of the
adequacy of clinical evidence provided to support proposed claims
that are consistent with product labeling. Provides consistent,
well-supported, and clear guidance to key stakeholders.
- Serves as the chair of CMLR review meetings and assists
Commercial with the planning and prioritization of proposed
promotional and disease state materials.
- Provides expert guidance related to Regulatory strategy to
commerical and key stakeholders during early development of
projects to ensure promotional goals can be achieved (e.g., target
product profile; clinical trial recruitment materials).
- Participates in CMLR meetings to resolve potential issues and
participates in escalation meetings, as needed.
- Supports metrics to measure and track effectiveness and
efficiency of the CMLR review process; provides recommendations for
process improvements to address issues, gains agreement of process
improvements from key stakeholders, and helps implement agreed-upon
- Understands broad concepts within regulatory affairs and
potential implications across organization. Proactively identifies
regulatory issues. Offers creative solutions and strategies,
including risk mitigation strategies.
- Leads internal A&P project workstreams (e.g., guidance
documents) and active participant at team staff meetings
- Being the contact point and expert matter for the promotional
review process and International review standards for selected
LOC's within the designated region
- Supports the development, integration and update of the LOC
processes and standards for promotional & non-promotional review
and ensure full training implementation for selected LOC's within
the designated region.
- Address unmet LOC needs for selected LOC's within the
designated region through LOC discussions and the development of
online collaboration tools.
- Being key contact person for selected LOC's within the
designated region for complaints regarding promotional or disease
awareness materials/activities in the designated region to drive
centralisation and global coordination and identify potential
competitor trends or risks that require further legal action.
- Collaborates with the US CMLR review teams for materials that
are intended for global audiences (e.g., global press releases, new
global campaigns). EDUCATION, BEHAVIOURAL COMPETENCIES AND
- Bachelor's Degree in a science-related field
- Ability to understand EFPIA and International (ex-US)
regulations basics on advertising and promotion for prescription
- Ability to understand the basics in pharmaceutical promotion
development and reviewprocess
- Strong interpersonal skills with ability to demonstrate
strategic and analytic thinking
- Demonstrated ability to clearly and concisely communicate.
- Effective written and verbal communication skills in order to
manage, motivate and drive decisions within teams.
- Proven skills in negotiation, influencing without authority and
working diplomatically through conflict.
- Ability to work independently, take initiative and complete
tasks to deadlines
- Previous experience in advertising and promotion; experience in
managing regulatory filing(s) or competitor complaints or medical
- Minimum of 2 year experience in International review and
approval process of pharmaceutical/biologics promotion Skills:
- Leadership Skills - ability to effectively manage and bring
working teams together for common objectives
- Strategic Approach - u nderstands the phases, processes and
techniques used within a clinical development environment, can
contribute to clinical study design discussions as needed.
- Analytical and Problem-Solving Skills - ability to understand
complex issues and propose achievable solutions.
- Communication Skills - ability to express one's self clearly
- Interpersonal Flexibility - ability to adapt to other
personalities in a respectful manner that is conducive to goal
- Teamwork - the ability to work well in a highly
cross-functional team environment
- Presentation skills - create and deliver presentations with
appropriate messaging and focused recommendations.
- International travel may be required
- Ability to attend offsite meetings that may involve overnight
stay This position is currently classified as "remote" in
accordance with Takeda's Hybrid and Remote Work policy.
$137,200 to 196,000 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. This posting is
made in compliance with Colorado's Equal Pay for Equal Work Act,
C.R.S. 8-5-101 et seq
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 , Associate Director, Global Regulatory Affairs, Advertising and Promotion- REMOTE, Executive , Cherry Hill, New Jersey
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