Responsibilities may include the following and other duties may be assigned
- Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections
- Leads or compiles all materials required in submissions, license renewal and annual registrations
- Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance
- Monitors and improves tracking / control systems
- Keeps abreast of regulatory procedures and changes
- May direct interaction with regulatory agencies on defined matters
- Recommends strategies for earliest possible approvals of clinical trials applications
SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a qualified discipline or specialty
Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results
May act as a mentor to colleagues or may direct the work of other lower level professionals
The majority of time is spent delivering and overseeing the projects from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education
DIFFERENTIATING FACTORS
Autonomy: Seasoned individual contributor
Works independently under limited supervision to determine and develop approach to solutions
Coaches and reviews the work of lower level specialists; may manage projects / processes
Organizational Impact: May be responsible for entire projects or processes within job area
Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments
Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties
Makes improvements of processes, systems or products to enhance performance of the job area
Analysis provided is in-depth in nature and often provides recommendations on process improvements
Communication and Influence: Communicates with senior internal and external customers and vendors
Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making
Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area
May manage projects, requiring delegation of work and review of others work product
Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience
May have practical knowledge of project management
Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C
F
R
214
2(h)( 4)(iii)(A) and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
Physical Job Requirements
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.