Mozarc Medical · 2 days ago

Senior Regulatory Specialist (New England area or Remote)

United States

Full-time

Remote

Mid, Senior Level

4+ years exp

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Responsibilities

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.

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.

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.

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.

Communicates with senior internal and external customers and vendors.

Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making.

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.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Regulatory submissionsProject managementClinical trials applicationsInternal auditsProcess improvementsCoachingMentoring

Required

Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.

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.

May have practical knowledge of project management.