About the role:
At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.
Join Takeda as an Manager, Marketed Products Growth and Emerging Markets (GEM) Regulatory Lead
How you will contribute:
Collaborates to define, develop and lead Marketed Products GEM strategies to maximize regulatory success towards achievement of program objectives
Manages, plans and executes the 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/guidances in Growth and 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 Marketed Products GEM for multiple projects including one highly complex program, focused on non-clinical and clinical aspects of 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
Provides regulatory input to the evaluation of new business development opportunities for Growth and Emerging Markets 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
Supports preparation activities for meetings with Health Authorities for the assigned program, as r equired . Interacts directly with HA, as r equired .
R epresents Takeda Marketed Products GEM in Health Authority meetings, as r equired . Effectively communicates and manages meeting outcome and next steps, as r equired
Bachelor's degree in a scientific discipline; BA accepted based on experience. Advance degree preferred.
Sound expeience within the pharmaceutical industry and including direct experience in regulatory affairs in development and/or post-marketing phases
4+ years of directly related regulatory experience is desirable
Sound working knowledge of regulations and guidances governing drugs and biologics in development and life-cycle management for growth and 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
Experience managing relationships with CRO s and/or contractors is desirable
Willingness to travel to various meetings, including overnight trips
Requires approximately 10-30 % travel
What Takeda can offer you:
Comprehensive Healthcare: Medical, Dental, and Vision
Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
Health & Wellness programs including onsite flu shots and health screenings
Generous time off for vacation and the option to purchase additional vacation days
Community Outreach Programs and company match of charitable contributions
Family Planning Support
Flexible Work Paths
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.
Base Salary Range: $101,500 to $145,000, based on candidate professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off. This posting is made in compliance with Colorado's Equal Pay for Equal Work Act, C.R.S. § 8-5-101 et seq
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 Massachusetts - Virtual Worker Type Employee Worker Sub-Type Regular Time Type Full time