Posted to MedZilla on 11/13/2019


Takeda Pharmaceuticals

US-MA, Associate Director/Senior Manager, Regulatory CMC - Development Products R0011899-MZ


 
 

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Job Description

OBJECTIVES:

  • As the RA CMC lead on Pharmaceutical Development and Regulatory project teams, independently develops and leads the execution of regulatory CMC development strategies for innovative First-In-Human and early stage products (pre IND, Phase 1, Phase 2).
  • Demonstrates leadership and comprehensive understanding of global RA CMC regulations and guidelines.
  • With limited 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.
  • Provides regulatory CMC expertise for new business development/due diligence activities.

ACCOUNTABILITIES:

  • Independently plans, executes and manages regulatory submissions for assigned early-stage development compounds.
  • 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. Stays abreast of current and evolving regulatory CMC requirements.
  • Recommends direction for key operations and new initiatives in collaboration with local and global stakeholders.
  • Lead team members that define CMC content (data and documentation) requirements for regulatory submissions.
  • With limited supervision, represents Takeda RA CMC in Health Authority meetings and leads preparation activities for meetings with Health Authorities on CMC related matters.
  • 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.
  • Develops and maintains constructive relations with key internal and external colleagues, e.g. cross functional colleagues within Takeda, Alliance Partners, and Health Authority representatives.
  • Evaluate new business development opportunities or participate on due diligence teams
  • 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.
  • 8+ 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).
  • 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.
  • Experience with global regulatory aspects of CMC involving undefined frameworks and technical complexity.
  • 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.
  • 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 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:

  • Requires approximately < 10% travel.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time


Please visit our website at takedajobs.com

 
 


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