Views:878 Applications:53 Rec. Actions:Recruiter Actions:46
Associated Director - Regulatory CMC (10-15 yrs)
- The Associate Director Regulatory Affairs CMC (RA-CMC) is accountable for strategic oversight of the assigned RA-CMC group of experts, through inspirational leadership and expertise.
- This role reports directly to the Senior management at the Regulatory Excellence Center, has accountability toward Global Regulatory Affairs CMC Head and collaborates and partners with other functions and other pharmaceutical companies in the context of Trade and Regulatory Associations, as required:
- Roles responsible for ensuring compliance with pharmaceutical regulations and laws as well as providing expertise on drug safety and medical topics. Includes jobs which are not directly specialized in one of the other defined Regulatory Affairs job families or which are fully responsible for the whole functional area.
IMPACT : Impacts the performance of a sizeable area or even the entire sub-function. Sets operational priorities and plans operations. Influences others internally and externally including senior leaders.
COMPLEXITY : Provides leadership to professional staff or managers to identify and solve (or is responsible for solving of) substantially complex or operationally important problems.
- Filters, prioritizes, analyzes and validates complex and dynamic information from a diverse range of external and internal sources, which requires in-depth understanding of how sub-functions work together.
ACCOUNTABILITY/ INDEPENDENCE :
- Accountable for the end results and performance of a sizeable team or multiple related teams. Decisions are guided by resource availability and organizational objectives and business plans.
- Develops policies. Focuses on performance and results as well as development of area of responsibility.
- Responsible for day-to-day management, setting objectives, coaching and developing employees, performance appraisal, determining employee compensation as well as the definition of team organization, roles and responsibilities and budget.
EXPERIENCE : Requires graduate background, extensive professional and substantial managerial experience. Also requires deep and/or broad expertise in own specialized discipline or field combined with in-depth knowledge of the market and competitors as well as industry developments to identify business opportunities.
- Experience in leading teams within a matrixed organization
- Minimum of 10 years of pharmaceutical industry experience, with at least 5 years of global CMC regulatory experience
- Degree in a Life Science or related discipline (minimum MSc or equivalent degree), higher degree referable (e.g. PhD in a scientific discipline)
Job Specific Competencies & Skills :
- Strong people management and leadership skills at a group level with a focus on building consensus through negotiation and best practices
- Collaborate across multiple functions and within the department in Leadership teams
- This role spans oversight of life cycle management of the approved product portfolio
- Accountability for the overall Regulatory CMC strategy ensuring consistency with the Global Regulatory and portfolio strategy
- Practical experience in one of the following area for biotech molecules - manufacturing process development, transfers, validation or analytical development and quality management
- In-depth knowledge of global pharmaceutical legislation
- Excellent written and spoken communication skills in English (knowledge of other European languages such as German is an asset )
- Good interpersonal skills and flexible mindset
- Ability to think strategically
- Ability to work in teams
- Project management
- Awareness of regulatory affairs contribution to Pharma business
- Excellent managerial skills
- Good organizational and planning skills