Global Regulatory Policy & Innovation - Labeling Lead

Company: Takeda Pharmaceutical
Location: Syosset
Posted on: May 12, 2022

Job Description:

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Job Description
OBJECTIVES/PURPOSE
Provide global regulatory intelligence (wiht a focus on US and EU regions) regarding product labeling, label compliance, labeling-related competitive intelligence, and other primary research objectives.
Work closely with GRA-labeling function and product teams to provide real-time therapeutic area and product-specific impact analysis of changes in labeling and product packaging regulations and laws.
Coordinate with regulatory compliance function to ensure timely implementation of upcoming and possible regulatory changes for Takeda marketed products.
Provide timely updates and presentations on identified trends and opportunities in labeling regulations within the US, EU, Japan, China, and emerging markets.
Lead and work with regional GRPI experts on external regulatory policy and innovation initiatives involving labeling reform and e-labeling.

ACCOUNTABILITIES

Accountable for regulatory intelligence - including monitoring, tracking, analysis, and reporting - of existing and emerging regulations concerning product labeling and packaging.
Accountable for coordination with Regulatory Compliance and Labeling Function to alert and provide context, analysis and guidance regarding global labeling regulations.
Coordinate with Global Regulatory Policy and Innovation colleagues on improving and accelerating regulatory intelligence systems, processes, and alerts improvements.
Lead and support for development and execution on external policy strategy regarding labelling and electronic labelling within the US, EU, Japan, China, and emerging markets.
Support and lead GRA and R&D participation in US regional committees to drive effective networking and representation to ensure a one voice policy.
Contribute and lead, where appropriate, to the development and implementation of appropriate systems, processes and standards within GRPI, US GRPI, GRA and across Takeda as assigned.
Partner with Government/Public Affairs to understand and monitor evolving trends for Access requirements regionally, work with internal stakeholders to identify opportunities/threats and advocate Takeda's positions externally.
Maintain consistent oversight of deliverables. Keep GRA management and all internal customers, partners and stakeholders abreast of progress and provide interim updates on ongoing activities and current initiatives. Ensure issues are escalated when needed and encourage resolution at the appropriate level.
Lead routine and ad hoc meetings within function and cross-functionally.--- Presents to senior management as relevant.
Responsible for demonstrating Takeda Leadership Behaviors.

DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
Comprehensive understanding of the pharmaceutical industry (e.g., clinical development, the prescription drug distribution process, etc), with a focus on regulations and laws pertaining to drug labelling and packaging.
Strong understanding of US and EU drug regulations, EMA / FDA structure and processes, and active/emerging issues regarding regulatory labelign.
Familiariy with regulatory intelligence data sources and platforms (e.g., Cortellis) that can be utilized within key regions of interest (US, EU, Japan, China, and Emerging Markets)

Leadership
Demonstrated ability to work across functions, regions and cultures
Enterprise level leadership with the ability to inspire, motivate and drive results
Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing
Proven skills as an effective team player who can engender credibility and confidence within and outside the company
Ability to distil complex issues and ideas down to simple comprehensible terms
Executive leadership presence and confidence
Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organizaiton

Decision-making and Autonomy
Broad decision making responsibilities: Ability to make highly complex decisions that impact the enterprise
Accountable for decision making for designated function
Ability to seek diverse input from multiple constituents and stakeholders to drive innovative solutions
Ability to incorporate feedback and ensure decisions are made swiftly to yield flawless execution

Accountable for designing and implementing vision and strategy for designated scope

Interaction
Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace
Ability to effectively implement R&D's partnership strategy
Effectively represent Takeda in High-level negotiations with the ability to resolve conflict in a constructive manner

Innovation
Visionary and forward thinking with the ability to influence and effectively drive organizational change and continuous innovation
Comfortable challenging the status quo and bringing forward innovative solutions
Ability to take risks implementing innovative solutions, accelerating time to market

Complexity
Ability to work in a global ecosystem (internal and external) with a high degree of complexity
Breadth of knowledge required across therapeutic areas, indications, and/or modalities

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
BS/MS - PhD, JD, MD, or equivalent graduate education strongly preferred. -Proven track record working with a major regulatory agency, specific experience in government affairs or policy is also desired.
[Director]: A minimum of 10 years of pharmaceutical industry experience. This is inclusive of 8 years regulatory experience or a combination of 10 years regulatory and o/or related experience in both development and post-marketing phases.
[Associate Director]: A minimum of 5 years of pharmaceutical industry experience. - This is inclusive of 3 years regulatory experience or a combination of 5 years regulatory and/or related experience in both development and post-marketing phases.
Strong knowledge of regulations and guidance governing drugs and biologics labeling in all phases of development, including post-marketing, in the US and EU, with a good understanding of basic regulatory requirements in other global markets (Japan, China) and emerging markets. Sound knowledge of intelligence tools and methods.
Understands and interprets complex scientific issues across projects and therapy area(s) of responsibility as it relates to regulatory requirements, regulatory intelligence, policy and strategy for the region.
Excellent collaboration/relationship building, strong influencing and negotiation skills, integrity and adaptability. Outstanding written and oral communication skills as well as managing and adhering to timelines. Proven success at stakeholder engagement across organizational levels and boundaries.
Must be strong communicator, and ability to explain complex regulatory issues, trends, and strategies to a wide range of stakeholders
Must be strong leader that creates vision for group. - Inspires and motivates group. - Takes stand on important issues in productive, respectful way. Able to mentor and develop skills of staff.
Experience managing relationships with CROs and/or contractors a plus.

** Preference will be given to candidates with a remote location near, and availability to work during the working hours of, the corporate office in Boston, Massachusetts and Washington, DC.**
In accordance with the CO Equal Pay Act, -Colorado Applicants Are Not Permitted to Apply.

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

USA - DC - Washington
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time

Keywords: Takeda Pharmaceutical, New Rochelle , Global Regulatory Policy & Innovation - Labeling Lead, Other , Syosset, New York