Senior Team Manager, Regulatory Change Management (RCM)
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