Senior Manager, Growth and Emerging Markets - Oncology, Regulatory Affairs
Company: Takeda Pharmaceuticals International GmbH
Posted on: February 25, 2021
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Theft Scheme targeting individuals seeking jobs with Takeda and
other employers. See below or here for more info. Senior Manager,
Growth and Emerging Markets - Oncology, Regulatory Affairs 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. Senior Manager, Growth and Emerging
Markets - Oncology, Regulatory Affairs Job ID R0028091 Date posted
01/13/2021 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 a Senior Manager, Growth & Emerging Markets -
Oncology in our Cambridge office. Here, everyone matters and you
will be a vital contributor to our inspiring, bold mission. As a
Senior Manager working on the Global Regulatory Affairs team, you
will be empowered with continuously looking at ways to define,
develop, and lead Growth & Emerging Market - Oncology strategies
and a typical day will include:-- POSITION OBJECTIVES: Defines,
develops and leads Growth & Emerging Markets - Oncology strategies
to maximize regulatory success to strengthen the product
development plan and to enable patient access in alignment with
program objectives, including all aspects of submission and timely
approval of investigational applications, market application and
life-cycle management as well as directly manage staff members,
provide direction, support, mentoring, and strategic guidance to
support scope of project work, when applicable. POSITION
- Collaborates to define, develop and lead Emerging Markets
strategies to maximize regulatory success towards achievement of
- Manages, plans and executes all aspects for the successful
preparation, submission and timely approval of investigational
applications, market applications, variations, post approval
reporting obligations and general product life cycle management of
- Effectively communicates the regulatory strategies, submission
plans and timelines; and impact assessments of trends, regulations
and changes related to assigned programs.
- Stays current with regulations / guidance's in Emerging Markets
for impact on drug development plans, registration and life-cycle
management to maximize the positive outcomes of the regulatory
applications and maintain registration compliance.
- Provides regulatory expertise on Emerging Markets for multiple
projects including one highly complex program, focused on
non-clinical and clinical aspects of drug development, registration
and / or post-marketing compliance and life cycle management.
- Assures ongoing efforts towards fulfilment of international
product approval conditions for late stage programs.
- Develops effective working relationships with Local Regulatory
Lead, Regional and Global Regulatory Team, Cross-functional Teams;
company's consultants and Business Partners.
- Evaluates new business development opportunities for Emerging
Markets and / or participates on due diligence teams.
- In coordination with local regulatory lead provides strategic
guidance / advice on emerging trends, regulations and changes, with
emphasis on those related to assigned program enabling proactive
approach and planning to future business needs.
- Leads or supports preparation activities for meetings with
Health Authorities for the assigned program, as required. Interacts
directly with HA, as required. Represents Takeda Emerging Markets
in Health Authority meetings. Effectively communicates and manages
meeting outcome and next steps, as required.
- Manages, trains, provide direction, strategic guidance and
solutions to projects to direct reports and / or mentors team
members, if required, to support scope of project work.
- Partner with the regional/LOC market access and LOC RA
colleagues to understand market access and reimbursement topics and
support opportunities to drive consolidated inputs into regional
product development plans. EDUCATION, EXPERIENCE AND SKILLS:
- BS degree in a scientific discipline; BA accepted based on
experience. Advanced degree preferred.
- Considerable experience within the pharmaceutical industry and
including direct experience in regulatory affairs in development
and /or post-marketing phases.
- 6 years of directly related regulatory experience is
- Sound working knowledge of regulations and guidance's governing
drugs and biologics in development and life-cycle management for
emerging markets; and US and/EU (relevant to role), including
interaction with Health Authorities.
- Generally strong in most and acceptable in all basic skill sets
such as oral and written communications, managing and adhering to
timelines, negotiation skills, integrity and adaptability.
- Able to demonstrate skill(s) in regulatory strategy such as
understanding broad concepts within regulatory affairs and
implications across the organization and globally; proactively
identifies regulatory issues; offers creative solutions and
strategies, including risk mitigation strategies.
- Generally strong in working well with others and within global
- Effective manager who can bring working teams together for
- Experience managing relationships with CROs and/or contractors
also preferred. TRAVEL REQUIREMENTS:
- Willingness to travel to various meetings, including overnight
trips. Requires approximately up to 10-30% travel. WHAT TAKEDA CAN
- 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 , Senior Manager, Growth and Emerging Markets - Oncology, Regulatory Affairs, Healthcare , Cambridge, Massachusetts
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