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Job Description

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/Manager, Global Regulatory Affairs CMC - Biologics in our Lexington, MA office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Manager/Manager working on the Global Regulatory Affairs CMC team, you will be empowered to develop and lead the execution of regulatory CMC investigational, registration and post-approval strategies for biological products, and a typical day will include:

OBJECTIVES:

• RA CMC member on Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle.




• Develops and applies a comprehensive understanding of global RA CMC regulations and guidelines for biological products to assigned projects to enhance probability of regulatory success and regulatory compliance.




• With moderate supervision, successfully communicates and negotiates with international Health Authorities as necessary, directly and indirectly.




• Develops constructive relationships with and proactively communicates issues to key internal and external colleagues, including Alliance Partners.

ACCOUNTABILITIES:

• With minimal supervision, plans, executes and manages regulatory submissions for assigned compounds in various phases of clinical development, global marketing applications, and post-approval life cycle activities.




• As a RA CMC product leader or member, ensures and/or enhances regulatory compliance with respect to filing requirements for assigned compounds throughout development and the commercial life cycle.




• Independently defines CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirement.




• With moderate supervision, represents Takeda RA CMC in Health Authority meetings and leads or supports CMC preparation activities for meetings with Health Authorities on CMC related matters.




• Interacts directly with international Health Authorities, as required. 




• Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.




• Fosters constructive working relationships when interacting with internal and/or external colleagues.




• Evaluates change proposals for global regulatory impact. and plans global variations and amendments.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.




• 6+ years pharmaceutical Regulatory CMC experience, including experience as an RA CMC product lead, or equivalent industry experience. (e.g., Pharmaceutical Development, Analytical Development, Production, Quality Assurance).




• Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support for biological products. 




• Proven ability to provide strategic regulatory guidance to drug development, registration, and post-market support teams.




• Able to deal with issues of critical importance with minimal supervision.  Provides regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.




• Demonstrates emerging leadership, problem-solving ability, flexibility and values teamwork.




• Exercises good judgement in elevating and communicating actual or potential issues to line management.




• Excellent written and oral communication skills required.




• Active participation in Agency/Industry groups/forums preferred

PHYSICAL DEMANDS:

• Routine demands of an office based environment.




• Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).




• Carrying, handling and reaching for objects.




• Ability to sit or stand for long periods of time while traveling.

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




• Tuition reimbursement




• 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




• Community Outreach Programs

Empowering Our People to Shine

Learn more at takedajobs.com.

No Phone Calls or Recruiters Please.

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Full time