Senior Regulatory Affairs Specialist

2 weeks ago

Jacksonville, United States ClinChoice Full time

Position: Senior Regulatory Affairs Specialist

Employment type: 1 year Contract/ Permanent

Location: Jacksonville, FL or Irvine CA - 2 days per week


ClinChoice is a global CRO that offers high-quality one-stop service to biopharmaceutical, medical device, and consumer products clients. Some of these services include clinical operations, project management, biostatistics, data management, regulatory affairs, medical affairs, and pharmacovigilance. ClinChoice has established major delivery centers across the US, Canada, China, Europe, India, Japan, and the Philippines. It has over 4,000 employees globally, with a strong and talented team, and a growing clinical operations presence in seven countries across Asia, North America, and Europe.


POSITION SUMMARY


Guided by supervision, the individual in this role provides regulatory support in a number of areas, including but not limited to:


A. Reviewing/analyzing modifications to product, manufacturing process, packaging, etc. to determine impact of registration status of approved products and to determine appropriate regulatory pathway.

B. Reviewing and approving advertising and promotion materials

C. Performing re-registration activities to support registrations Outside of the United States (OUS)

D. Assisting in developing regulatory strategies for new product development initiatives.

E. Performing regulatory operations tasks including archiving/assembling/publishing regulatory filings and other health authority communications.

Adheres to environmental policy, procedures, and supports department environmental objectives.


ESSENTIAL FUNCTIONS / RESPONSIBILITIES

Under supervision, the Senior Regulatory Affairs Specialist will be responsible for:

A. Coordinating and submitting registrations for maintenance of existing products, including international registrations, updates to Technical Documentation Files, Declarations of Conformity, etc.

B. Reviewing engineering/device change requests.

C. Researching, collecting data, responding to requests from regulatory agencies to prepare and submit documentation for US and OUS marketing clearances/approvals, as well as to provide routine information to business associates and their affiliates.

D. Provides regulatory guidance to various internal teams/department personnel and responds to regulatory related product requests.

E. Represents the regulatory affairs department in cross-functional project teams, plans and schedules regulatory deliverables to achieve project milestones.

F. Prepares associated product labeling to meet registration requirements for new or modified products; reviews product labeling associated with existing product to ensure compliance to regulatory requirements.

G. Assists in development of best practices, work instructions for Regulatory Affairs processes and

H. Provides Regulatory Affairs support for internal and external quality system audits.


QUALIFICATIONS

Minimum education required for competent performance:

Bachelor’s Degree - Scientific Discipline (preferred)


Minimum of 3 years of work experience within the Medical Device or Pharmaceutical industry or 0-3 years with a PharmD/PhD. Strong communication, organizational, negotiation and interpersonal skills


General knowledge, understanding and application of principles, concepts and practices related to FDA regulations. Regulatory knowledge to maintain legal status of products and minimize risk. Broad based technical knowledge and skills in diverse business functions (e.g., R&D, Operations, QA, laboratories, marketing, etc.) are a plus. Self-motivated and committed to a team focused approach to problem solving. Ability to organize and analyze technical data and identify issues or gaps. Ability to provide innovative solutions within the boundaries of regulation.



ClinChoice is an Equal Opportunity Employer / Committed to Diversity

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