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Associate Director/Director, Global Regulatory Intelligence & Policy

Company: Amazon Workforce Staffing
Location: Cambridge
Posted on: September 17, 2020

Job Description:

Associate Director/Director, Global Regulatory Intelligence & Policy Company: Takeda Pharmaceuticals International GmbH

Location: Cambridge

Posted on: September 12, 2020

Job Description:

National Postdoctoral Association Career Center AssociateDirector/Director, Global Regulatory Intelligence & Policy

T Associate Director/Director, Global Regulatory Intelligence &Policy Takeda

Cambridge, 85 Bridle Road, United States

Are you looking for a patient-focused company that will inspireyou and support your career? If so, be empowered to take charge ofyour future at Takeda. Join us as a Director/Associate DirectorGlobal Regulatory Intelligence & Policy in Cambridge, MA.

At Takeda, we are transforming the pharmaceutical industrythrough our R&D-driven market leadership and being a values-ledcompany. To do this, we empower our people to realize theirpotential through life-changing work. Certified as a Global TopEmployer, we offer stimulating careers, encourage innovation, andstrive for excellence in everything we do. We foster an inclusive,collaborative workplace, in which our global teams are united by anunwavering commitment to deliver Better Health and a BrighterFuture to people around the world.

Here, you will be a vital contributor to our inspiring, boldmission.

As a Director/Associate Director working on the GlobalRegulatory Intelligence & Policy team, you will be empowered tosupport regulatory interactions on policy and advocacy issues, anda typical day will include:

OBJECTIVE:

Global regulatory intelligence contact for key stakeholdersincluding therapeutic areas and regional teams as determined incollaboration with regional EU, US, Japanese and EM RegulatoryIntelligence colleagues.

Building relationships with key regulatory decision makers andindustry networks globally. Provide guidance for companyrelationships with other regulators and decision makers to furtherexpand these relationships.

Leads within Global Regulatory Intelligence & Policy to createvision for Regulatory Intelligence working collaboratively withregional colleagues with delivery of a work plan to meet thatvision. Also works closely with the Regional Policy leads to drivesuccess at the regional regulatory interface.

With Global Regulatory Intelligence & Policy colleagues, defineand oversee the standardization and implementation ofsystems/processes to monitor the regulatory environment for changesthat may have an impact on Takeda's products and goals. As suchbring functional excellence to Global Regulatory Intelligence &Policy. Develop and drive best practices and excellence inexecution within the department and cross-functionally.

Utilizes his/her experience to oversee the strategic assessmentof external regulatory changes globally and, to work with subjectmatter experts within the Company, to drive or support thedecision-making process to understand the priorities the regulatoryrisks & opportunities globally: the internal impact analyses,development of strategies/positions and drive for appropriateaction(s) relevant to Takeda's Therapeutic Areas of focus anddevelopment projects.

ACCOUNTABILITIES:

Represent Global Regulatory Policy & Intelligence and GlobalRegulatory Affairs on internal and external forums/networks asassigned. Provides impactful summaries and strategic advice, backto the business, regarding assigned internal/external activities.Provides leadership to influence the regulatory environment to meetbusiness needs.

Oversee Global Regulatory Affairs participation in regionalcommittees to drive effective networking and representation toensure a once voice policy.

Develop and execute Regulatory Intelligence strategy. Keepabreast of internal and external changes, trends, developments andother dynamics relevant to the regulatory environment that mayimpact Takeda's regulatory strategy and access strategies andpropose action plan.

Play a key role in the development and implementation ofappropriate systems, processes and standards within GlobalRegulatory Intelligence & Policy, Global Regulatory Affairs andacross Takeda as assigned.

Contribute to the development of a global regulatory policy andadvocacy strategy for Global Regulatory Intelligence & Policy. Workclosely and partner with Global Regulatory Intelligence & Policycolleagues and a number of subject matter experts to plan andexecute global regulatory advocacy positions, strategies andtactics and facilitate engagement with regulators on key topics ofinterest. This includes to liaise closely with colleagues (R&D,Policy, etc.) leading policy activities in the external environmentto ensure regulatory insights and overall alignment on Takedaposition.

Contribute to or has primary responsibility for the managementand maintenance of special projects such as Global RegulatoryAffairs Priority Topic list, position papers, and regulatoryissues/trends reports, as assigned.

Partner with Government/Public Affairs to understand and monitorevolving trends for Access requirements regionally/globally, workwith internal stakeholders to identify opportunities/threads andadvocate Takeda's positions externally.

Maintain consistent oversight of deliverables. Keep all internalcustomers, partners and stakeholders abreast of progress andprovide interim updates on ongoing activities and currentinitiatives. Ensure issues are escalated when needed and encourageresolution at the appropriate level.

Lead routine and ad hoc meetings with function andcross-functionally. Presents to senior management as relevant.

Manages personnel within group to ensure coverage for regionalresponsibilities; Elevates needs when necessary.

Requirements

EDUCATIONAL, BEHAVIOURAL COMPETENCIES AND SKILLS:

BSc, Advanced scientific related degree preferred; BA acceptedbased on experience. Advanced degree preferred.

A minimum of 10 years of pharmaceutical industry experience.This is inclusive of 8 years regulatory experience or a combinationof 10 years regulatory and/or related experience in bothdevelopment and post-marketing phases.

Deep understanding of regulations and guidances governing drugsand biologics in all phases of development, includingpost-marketing, in the US and/or EU (relevant to role), with a goodunderstanding of basic regulatory requirements and emergingmarkets. Sound knowledge of intelligence tools and methods.

Understands and interprets complex scientific issues acrossprojects and therapy area(s) of responsibility as it relates toregulatory requirements, regulatory intelligence, policy andstrategy for region. Proven track record working with a majorregulatory agency, specific experience in government or policy isalso desired.

Excellent collaboration/relationship building, stronginfluencing and negotiation skills, integrity and adaptability.Outstanding written and oral communication skills as well asmanaging and adhering timelines. Proven success at stakeholderengagement across organizational levels and boundaries.

Must be strong overall and able to train/develop staff in thearea of regulatory strategy such as understanding broad conceptswithin regulatory affairs and implications across the organizationand globally; proactively identifies regulatory issues; offerscreative solutions and strategies including risk mitigationstrategies.

Ability to develop regulatory strategy to balance short andlong-term objectives, and drive teams to make decisions and achievedeliverables within agreed parameters and timescales.

Generally strong in working well with others, within globalteams and communicating with senior leadership.

Must be strong leader that creates vision for group, inspiresand motivates group. Takes stand on important issues in productive,respectful way. Able to mentor and develop skills of staff.

Experience in managing personnel required; experience managingrelationships with CROs and/or contractors also preferred.

PHYSICAL DEMANDS:

Manual dexterity required to operate office equipment (i.ecomputers, phones, etc).

Carrying, handling and reaching for objects.

Ability to sit or stand for long periods of time whiletraveling.

TRAVEL REQUIREMENTS:

Willingness to travel to various meetings or client sites,including overnight trips. Some international travel may berequired.

Requires approximately 10-30%.

WHAT TAKEDA CAN OFFER YOU:

401(k) with company match and Annual Retirement ContributionPlan

Company match of charitable contributions

Health & Wellness programs including onsite flu shots and healthscreenings

Generous time off for vacation and the option to purchaseadditional vacation days

Location:

Cambridge, 85 Bridle Road, United States

15800 Crabbs Branch Way, Rockville, Maryland 20855 (301)984-4800

Keywords: Takeda Pharmaceuticals International GmbH, Cambridge , Associate Director/Director, Global Regulatory Intelligence & Policy, Other , Cambridge, Massachusetts

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