Manager, Emerging Markets Regulatory Affairs - United States
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 Manager, Emerging Markets Regulatory Affairs in ourCambridge, MAoffice.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Manager, Emerging Markets Regulatory Affairsworking on theGlobal Regulatory Affairs team, you will be empowered tobe innovative andcollaborative, and a typical day will include:
- With moderate supervision, executes on Emerging Markets regulatory strategies for product lifecycle, including product development and post-market (all therapeutic areas, biologics and small molecules).
- Interfaces cross-functionally within RA, as well as with commercial, medical, global marketing, etc. to identify what Emerging Markets regulatory requirements are necessary and how to best move forward to meet project plans.
- Ensures execution of the strategy to ensure proper facilitation and preparation of Emerging Markets regulatory documents and various submissions, as well as any compliance matters;
- Applies a solid familiarity of Emerging Markets RA regulations and guidelines by applying interpersonal skills and expert RA Emerging Markets knowledge to address and overcome challenges that arise during development and commercialization.
- Successfully communicates with Emerging Markets Health Authorities, as necessary, with moderate supervision.
- Executes the regulatory submissions to support product development and approval efforts for all products (all indications) in non-US and EU countries (e.g., primarily focusing on the emerging markets including Asia pacific, Latin America, Russia, India, etc. but also including other developed countries such as Australia, S. Africa). Where necessary, this individual will manage CRO/contractor support for agreed predefined standards to meet planned project needs and ad hoc advice.
- Ensures country-specific regulations and local environments are in compliance to ensure the strategic direction in the development of the Emerging Markets component of the Regulatory Development Plan for programs are completed successfully.
- Stays current with revised regulations/guidance for impact on product development plans in order to propose and implement appropriate changes.
- Works closely with functional areas throughout the company. Advises functional areas regarding content requirements for Emerging Markets regulatory submissions; review documents from functional contributors for consistency and completeness.
- Has a solid understanding of regulatory requirements and environment for development and registration of new products for a specific region such as Asia Pacific, Latin America, etc. in order to serve as a resident expert
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- BS/BA Degree in a scientific discipline. Preferred advanced degree (MS/PharmD/PhD).
- A minimum of 4 years of directly related regulatory international bio/pharmaceutical experience.
- Solid knowledge of regulations, policies, procedures, drug development guidelines and compliance for all emerging and selected developed markets
- Some experience participating in meetings with Regulatory Agencies, preferred.
- Demonstrated leadership, problem-solving ability, flexibility and teamwork.
- Proven ability to provide strategic regulatory guidance to drug development, registration and post-market support team.
- Good working understanding of projects in assigned area of responsibility allowing for creative and innovative solutions to address potential hurdles in development.
- Strong negotiation and communication skills and the ability to work independently and function well in a team-oriented environment are essential.
- Excellent written and oral communication skills required.
- Knowledge of eCTD
- Routine demands of an office based environment.
- 15%; some international travel required
WHAT TAKEDA CAN OFFER YOU:
To further support and inspire our employees, our benefits include:
- Health & Wellness Programs
- 401k Savings and Retirement Plan and Matching Contribution
- Annual Retirement Contribution Plan
- Matching Gifts Program
- Career & Professional Development
- Community Outreach Programs
- Takeda Recognition Program
Empowering Our People to Shine
Learn more at takedajobs.com.
Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx
No Phone Calls or Recruiters Please.