Senior Team Manager, Regulatory Change Management (RCM)

04 May 2021
18 May 2021
Full Time
Contract Type

Position Purpose

To oversee and direct the CMC change management activities and CMC submission management/ operational execution responsibilities for the global CMC submission portfolio, through leadership and engagement of RCMs, stakeholders and regulatory partners as part of a global business model.

Executes strategic direction, defines and upholds required Chemistry Manufacturing and Control (CMC) document and/or regulatory submission standards and practices in support of manufacturing changes, commercially driven new registrations and compliance driven full product license lifecycle management to multiple regulatory authorities. Cultivates a positive, highly engaged workforce that understands applicable regulatory obligations, tight, business-critical deadlines within a highly regulated environment.

Accountable for ensuring proactive management of CMC contributions and/or submissions to meet business needs and at all times maintain a comprehensive and detailed oversight of process, quality control and regulatory workload within the function.

Proactive coordination of load balancing, resources and training in support of cross regional activity; assessment and monitoring of trends in portfolio activity that drive changes in operating model.

Represent GRO and Submissions Management as a direct partner for key stakeholders, including designated functions and/or markets.


Technical Skill Requirements

  • Demonstrated business acumen; proven organizational management skills, and ability to manage multiple demands simultaneously; ability to respond to tight timelines in a highly regulated environment
  • Significant knowledge of drug development process, regulatory affairs, and submissions management; demonstrating an understanding of regional and national regulatory filing guidelines and dossier requirements
  • Ability to partner with Senior leaders in support of organizational objectives through strategic business planning
  • Demonstrated ability to lead and deliver through others in a matrix model
  • Demonstrated ability to deliver swift decision in ambiguous or urgent circumstances
  • Advanced knowledge of the processes, systems and regulatory guidance and a detailed understanding/knowledge of principles and concepts of other disciplines
  • Promotes peer relationships and can quickly find common ground and solve problems for the good of all; easily gains trust and support of peers; encourages collaboration.
  • Uses a range of effective communication styles and creates an inclusive environment with internal/external stakeholders to deliver goals and promote quality; uses diplomacy and tact and can diffuse high-tension situations comfortably.

Qualifications (i.e., preferred education, experience, attributes)

  • B.S./B.Sc is in Pharmacy, Life Sciences, Business or Information Technology (desirable); equivalent relevant professional experience will be considered.
  • Proven aptitude in project management and process redesign
  • Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards
  • Demonstrated excellence in interpersonal (verbal and written) skills
  • Ability to successfully establish and build collaborative relationships with colleagues within and across an organization
  • Demonstrated leadership and flexibility in dealing with change and diversity as part of a global team
  • Experience in resource management in a professional & dynamic environment
  • Multi-lingual skills desirable.
  • Familiarity with pharmaceutical organizational structures, systems, and culture is preferred


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