Senior Manager, Growth and Emerging Markets - Oncology, Regulatory Affairs

Company: Takeda Pharmaceuticals International GmbH
Location: Cambridge
Posted on: February 25, 2021

Job Description:

The health and safety of our employees and candidates is very important to us. Due to the current situation related to the Coronavirus (COVID-19), we're leveraging our digital capabilities to ensure we can continue to recruit top talent at Takeda. As your application progresses, you may be asked to use one of our digital tools to help you through your recruitment journey. If so, one of our colleagues will explain how these tools will be used during the recruitment process. Thank you. *Please be aware of an Identity 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 ACCOUNTABILITIES:

• Collaborates to define, develop and lead Emerging Markets strategies to maximize regulatory success towards achievement of program objectives.
• 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 assigned program.
• 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 desirable.
  • 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 teams.
  • Effective manager who can bring working teams together for common objectives.
  • 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 OFFER YOU:
      • 401(k) with company match and Annual Retirement Contribution Plan
      • Company match of charitable contributions
      • Health & Wellness programs including onsite flu shots and health screenings
      • 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