SUMMARY/JOB PURPOSE:
Responsible for gathering and interpreting global regulatory intelligence to inform Exelixis policy and practices. Ensures timely preparation and completion of action plans to maintain Exelixis processes and procedures, in response to changes in regulatory requirements. Oversees Regulatory Affairs procedural documents in the Quality Management System. Establishes processes and measures to monitor conformance with Regulatory Affairs procedures and compliance with regulatory requirements.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Monitor the external regulatory environment to identify emerging intelligence with relevance to Exelixis.
- Establish formal and informal networks to keep up to date with regulatory intelligence and interpretation.
- Interpret regulatory intelligence to assess the impact on Exelixis and advise Regulatory Affairs leadership accordingly.
- Lead Regulatory Affairs action planning of updates to policies, processes and procedures.
- Monitor the completion of regulatory intelligence related action plans.
- Establish cross-functional relationships and an internal network to plan actions resulting from new regulatory intelligence.
- Business owner for the enterprise regulatory intelligence system.
- Coordinate activity amongst all Regulatory Affairs groups and with Exelixis Quality Assurance, to establish appropriate quality procedures, in the form of policies, standard operating procedures and work instructions.
- Establish process and measures to ensure Regulatory Affairs conformance with quality procedures.
- Establish process and measures to ensure Regulatory Affairs compliance with regulatory requirements.
SUPERVISORY RESPONSIBILITIES:
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:
- Bachelor's degree in related discipline and a minimum of thirteen years of related experience; or,
- Master's degree in related discipline and a minimum of eleven years of related experience; or,
- PhD degree in related discipline and a minimum of eight years of related experience; or,
- Equivalent combination of education and experience.
Knowledge/Skills:
- Develops and manages plans, establishes timelines, sets standards for performance. Proactively balances commitments and overcomes challenges to complete multiple activities and achieve results. Takes pride in delivering high quality work.
- Applies extensive knowledge of the regulatory framework, industry drivers and practices to develop innovative approaches and manage complex work.
- Demonstrates clear and effective verbal and written communication. Provides timely and appropriate information updates. Speaks clearly and confidently in one to one situations and effectively presents information to cross-functional groups of colleagues.
- Strong interpersonal skills and ability to accommodate differing views to influence an agreed upon resolution.
- Manages effectively performing teams, facilitates team alignment and achievement of common objectives. Engages internal and external stakeholders to establish productive collaborative relationships.
- Applies knowledge of organizational goals and objectives and demonstrates advanced skill and insight in gathering, analysing and applying key information to solve problems. Provides regulatory expertise to cross-functional teams. Understands longer term consequences of decisions and actions.
- Effectively leads and manages a team, acting with integrity to build trust and execute on team objectives that contribute to departmental goals.
JOB COMPLEXITY:
- Capable of proactively assessing workload, trends, tasks and priorities for area of responsibility.
- Plans and executes multiple activities.
- Considers alternative methods and contingency plans to avoid potential issues.
- Designs and implements solutions to address project level challenges, taking into consideration the broader impact.
WORKING CONDITIONS:
DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
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