TakedaPharmaceutical Nordics AB · 8 hours ago
Director, Global Regulatory Affairs CMC
Boston, MA
Full-time
Hybrid
Director/Executive
$174K/yr - $274K/yr
10+ years expTakedaPharmaceutical Nordics AB is a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. The Director of Global Regulatory Affairs CMC will lead regulatory CMC strategies for assigned products and ensure compliance throughout the product lifecycle while mentoring team members and communicating effectively with Health Authorities.
Pharmaceuticals
Responsibilities
Independently develops and leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products as GRA CMC Product Lead
Represents and contributes to Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle
Demonstrate a high level of leadership and expert understanding of GRA CMC regulations and guidelines
Apply and adapt this understanding to projects to enhance probability of regulatory success and regulatory compliance
Strong analytical or process understanding that enables the development of robust and accurate submissions
Develops constructive relationships with and proactively communicates issues to key internal and external colleagues, including Alliance Partners
Successfully communicates and negotiates with Health Authorities – directly and indirectly
Able to apply expert GRA CMC knowledge to address and overcome challenges that arise during development and commercialization
Acts as mentor / coach to all GRA CMC members – as required
Develops, executes and oversees regulatory submissions preparation per the GRA CMC Product Team CMC strategy
Guide the team to define and drive strategy for CMC regulatory dossier content and reviews this content for conformance with established requirement
Represents Takeda GRA CMC in Health Authority meetings and drives preparation activities for meetings with Health Authorities on CMC related matters
Provide guidance to the teams on administrative procedural topics while interacting with International Heath Authorities - as required
Fosters constructive working relationships when interacting with internal and/or external colleagues
Providing strategic input into change control evaluation - as required
As a GRA CMC member, ensures and / or enhances regulatory compliance
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
Reviews, provides regulatory CMC input and approves – as needed – technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards
When in a GRA CMC Product Team lead role, prepares and maintains relevant regulatory documentation (e.g., technical regulatory strategy documents, storyboards, risk assessments, etc.) and provides tactical regulatory guidance to product teams in line with global regulatory strategies
Accountable for development and / or commercial products approvals and meeting targets for projects/products within respective modalities
Proactively identifies regulatory CMC risks, ensuring timely communication with line management
Leads assigned global regulatory submissions (e.g., Core Dossiers, INDs, CTAs, BLAs, MAAs, Variations, etc.) through product lifecycle
Provides global regulatory input and support on product-compliance related activities including change controls, deviations, and investigations
Works effectively across a complex matrix environment in GRA with GRLs, CMC RA project leads and other GRA sub-functions (e.g., Growth & Emerging Markets, Strategy, Labelling, etc.) to ensure effective strategies are implemented and project execution is on target
Supports development of strategies, tools, and trainings to further the GRA CMC roadmap
Proactively communicates CMC regulatory strategies, key issues and risks through assigned programs / products development activities and LCM in adequate and timely manner to cross-functional programs/ products teams and management level within GRA CMC, GRA, PS, GMS and QA - as appropriate
Qualification
Required
BS/BA Degree in a Scientific Discipline, Advanced Degree (M.S., Ph.D., etc.) required
10+ years of overall biopharmaceutical/device industry experience with 8+ years pharmaceutical Regulatory CMC and / or devices experience, while leading major submissions during LCM, development – including preparation of NDA/NLA/MAA
Equivalent industry experience in Pharmaceutical Development, Analytical Development, Production, Quality Assurance can be considered
Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support
Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams
Analyze issues with attention to detail
Ability to assess alternative approaches
Base regulatory strategy recommendations on precedents and other regulatory intelligence as well as regulations and guidelines
Able to deal with issues of critical importance with minimal oversight
Exercises good judgment in elevating and communicating actual or potential issues to line management
Applies directions taken by the company
Demonstrates emerging leadership, problem-solving ability, flexibility and values teamwork
Intentionally promotes an inclusive culture
Applies given prioritization framework with limited support
Excellent written and oral communication skills required
Exercises good judgement in elevating and communicating actual or potential issues to line management
Benefits
Medical, dental, vision insurance
A 401(k) plan and company match
Short-term and long-term disability coverage
Basic life insurance
A tuition reimbursement program
Paid volunteer time off
Company holidays
Well-being benefits
Up to 80 hours of sick time
Up to 120 hours of paid vacation
Company
TakedaPharmaceutical Nordics AB
Takeda Pharma AB is engaged in sales marketing For USA
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase