|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 Director / Associate Director, Global Regulatory Affairs - CMC in our Cambridge office.|
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Director / Associate Director working on the Global Regulatory Affairs - CMC team, you will be empowered to xxxx and xxxx, and a typical day will include:
- As a member on Regulatory, Pharmaceutical Development, and/or Commercial project team, this position is responsible and accountable for regulatory CMC development, registration and post-approval strategies as for assigned products.
- Ensures global strategies are successfully executed across both new product development and existing portfolio life cycle management.
- Interfaces cross-functionally both within the regulatory affairs team as well as with commercial, clinical development, global marketing, quality, etc. to ensure that data are identified, obtained and effectively presented for the product registration world-wide.
- Demonstrates leadership and comprehensive understanding of global RA CMC regulations and guidelines by applying interpersonal skills and expert RA CMC knowledge to address and overcome challenges that arise during development and commercialization
- Successfully communicates and negotiates directly and indirectly with international Health Authorities as necessary.
- Develop constructive relationships with and proactively communicates issues to key internal and external colleagues, including Alliance Partners.
- Provides CMC regulatory expertise for new business development/due diligence activities
- Independently plans, executes and manages regulatory submissions for assigned compounds in various phases of clinical development, global marketing applications, and post-approval life cycle activities
- Member of global cross-functional teams which require experienced interpretation of applicable EMA/FDA/ICH/WHO/Global regulations to ensure CMC compliance within the organization.
- Recommends direction for key operations and new initiatives in collaboration with local and global stakeholders.
- Leads team members that define CMC content (data and documentation) requirements for regulatory submissions and reviews content for conformance. Ensures and/or enhances regulatory compliance with respect to filing requirements for assigned compounds throughout development and the commercial life cycle.
- Manages and develops staff, as required, including staff professional development and project oversight accountability
- Represents Takeda RA CMC in Health Authority meetings and leads CMC preparation activities for meetings with Health Authorities on CMC related matters
- Interacts directly with international Health Authorities, as required. Participates in and/or facilitates agency meetings.
- 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. Provides solutions to prevent recurrence of issues.
- Stays abreast of current and evolving regulatory CMC requirements, applies this knowledge to assigned projects, and shares knowledge and experience with others to support their development
- Evaluates change proposals for global regulatory impact and plans global variations and amendments.
- Leads and/or supports new business process development activities
- Evaluate new business development opportunities or participate on due diligence teams
EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:
- BS/BA Degree in a Scientific Discipline, Advanced Degree preferred
- 8 + years pharmaceutical Regulatory CMC experience including experience as an RA CMC product lead, or equivalent industry experience.
- Experience with pharmaceutical development of active pharmaceutical ingredient/drug substances or drug products, analytical characterization, process scale-up and/or regulatory registration of products is required.
- Proven ability to liaise with Regulatory Agencies having served as lead in successful Agency Interactions related to CMC submissions and product development meetings, international experience preferred.
- Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
- Proven ability to provide strategic regulatory guidance to drug development, registration, and post-market support teams.
- Able to deal with issues of critical importance. Provides regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.
- Demonstrates leadership, problem-solving ability, flexibility and values teamwork
- Demonstrated ability to work well within a matrix structure in a complex environment.
- Exercises good judgement in elevating and communicating actual or potential issues to line management and presents solutions to those issues
- Excellent written and oral communication skills required
- Active participation in Agency/Industry groups/forums expected
- RAC certification desirable but not mandatory
- Routine demands of an office based environment.
- Up to 30% travel may be required
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
Community Outreach Programs
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
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