Director, Global Regulatory Affairs, Advertising & Promotion - Oncology - Remote
Company: Takeda Pharmaceuticals
Posted on: September 23, 2022
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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 DescriptionAre 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 a Director, Advertising & Promotion - Oncology -
Global Regulatory Affairs in our Cambridge, MA office or role can
be performed remotely (virtually). This will be an Individual
Contributor position.Here, everyone matters and you will be a vital
contributor to our inspiring, bold mission. As a Director,
Advertising & Promotion working on the Global Regulatory Affairs
team, you will be empowered to lead the review, submission and
execution of advertising and promotional items across 2 or more
therapeutic areas and a typical day will include: OBJECTIVES As an
Individual Contributor, you will:
- Lead Regulatory Affairs initiatives to ensure all promotional
items are prepared and executed in accordance with applicable
regulations and guidelines and company policy.
- Lead, manage or negotiate any major issues with FDAs Office of
Prescription Drug Promotion (OPDP) as required.
- Mentor and develop skills of staff.ACCOUNTABILITIES
- Oversees regulatory guidance provided by team to ensure
compliance with promotional regulations.
- Responsible for Global Processes and applications of codes and
regulations for Global review of products.
- Oversight/Accountable for all submissions within group. Approve
- Manages personnel within group to ensure coverage for brand and
therapeutic area responsibilities.
- Understand and interpret complex scientific issues as it
relates to regulatory requirements and promotional strategy. Able
to mentor and develop skills of staff.
- Understands broad concepts within regulatory affairs and
implications across organization. Proactively identifies regulatory
issues. Offers creative solutions and strategies, including risk
- Develops strategy for efficient and appropriate OPDP review and
play a key role in life cycle management strategy such that
scientific, regulatory and commercial plans are aligned for all
areas of responsibility.
- Identifies trends in Agency enforcement, policies and
procedures; incorporates into regulatory decisions and strategy;
responsible for establishing and maintaining a process for sharing
enforcement trends etc, with appropriate TPUSA employees.
- Reviews competitive materials and interacts with FDA to urge
enforcement activity as necessary.
- Develop department area by ensuring structure; organization and
functional processes are aligned by ensuring compliance and
defining SOPs and training of core team and business partners.
Responsible for development and training of global review
- Works closely with Medical, Legal, OEC, Marketing, Marketing
Operations, Sales, and Sales Training departments as well as
external advertising agencies and consultants in the successful
development of promotional and applicable training materials. Works
to align promotional goals with the goals of the cross-functional
- Support development and maintenance of product labeling with
Regulatory Affairs Labeling and Strategy groups. Support regulatory
direction and review for pre and post launch regulatory strategies
(which may include label (PI), protocols, SNDAs, etc)
- Lead for Promotion and Advertising Regulatory Review for
- Other duties as assigned or neededEDUCATION, EXPERIENCE AND
- BS/BSc is required. Advanced scientific related degree: PhD or
PharmD is preferred.
- 10 years pharmaceutical or related industry; inclusive of >
8 years Regulatory, Medical Affairs or related experience.
- Experience in managing multiple filings e.g. Launch Advisory
Materials or responses to enforcement letters. Promotion and
Advertising experience in multiple therapeutic areas
- Prior people management required; multiple personnel for > 5
- Generally strong in working well within Regulatory,
cross-functionally and communicating /negotiating with senior
- Must be strong in strategic and problem solving skills over all
with an ability to identify the critical issues of problems or
opportunities using appropriate information and judge risk based on
FDA trends; determines the causes and possible solutions to the
- Must be strong leader that creates vision for the group.
Inspires and motivates group. Takes stand on important issues in
productive, respectful way. Must have demonstrated outstanding
- Ability to express ones self clearly and concisely; documents
issues and/or concerns concisely and comprehensively; adjusts
language and/or terminology appropriate to the audience; ability to
communicate effectively with business partners and company
management to enhance efficient, timely and balanced decision
making. Must be especially strong in negotiation skills and
integrity. Works well with others, especially on a cross-functional
team. Demonstrated ability to effectively manage and bring together
working teams together for common objectives. Presentation at
industry meetings is desirable.
- Ability to capture knowledge and share within the organization;
improves solutions, processes, and deliverables through use of
information; improves information capital by contributing
experience, theories, deliverables and models for others to
- Ability to assist in the development of an operating budget to
monitor and control expenditures.
- Understands the phases, processes and techniques used within a
clinical development environment, can contribute to clinical study
design discussions as needed.
- Understand FDA regulations relative to advertising and
promotion, for health professional and consumer audiences.
Experience in managing multiple filings e.g. Launch Advisory
Materials or responses to enforcement or proactive complaints to
OPDP about competitors.
- Understands the pharmaceutical industry and has experience in
evaluating promotion and advertising materials in multiple
- Understands medical/therapeutic impact of products;
understanding of potential product applications, and competitive
- Understands Takedas operating structure and methods including a
thorough knowledge of the foreign-owned parent company.
- Maintains a current knowledge of applicable government
regulations, particularly those related to advertising and
promotion. Has a thorough knowledge of historical enforcement
actions and is readily able to use this in negotiation.LOCATION:
- Job Location: Role Remotely (Virtual)TRAVEL REQUIREMENTS
- Up to 30%
- Ability to drive or fly to various meetings/ client sites
limited overnight. Some international travel may be required.WHAT
TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution
- Tuition reimbursement
- 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
- Community Outreach ProgramsEmpowering Our People to Shine Learn
more at takedajobs.com#LI-VMEEO 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. LocationsMassachusetts -
VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull
Keywords: Takeda Pharmaceuticals, Lansing , Director, Global Regulatory Affairs, Advertising & Promotion - Oncology - Remote, Executive , Lansing, Michigan
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