Senior Regulatory Specialist (New England area or Remote) (Healthcare)
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.
Typically an individual contributor with responsibility in a professional 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.
Autonomy
Typically an individual contributor with responsibility in a professional 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.
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 & 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 & 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 & 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.
Req. Knowledge & Exp.
• 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.
