Job added in hotlist
Applied job
Contract job
90-day-old-job
part-time-job
Recruiter job
Employer job
Expanded search
Apply online not available
Similar Jobs
View more jobs in Irvine, CA
View more jobs in California

Job Details

Regulatory Affairs Specialist

Company name
ProClinical Ltd

Location
Irvine, CA

Apply for this job






3 hit(s)  

Profile

At ProClinical, we are seeking an individual to fill the role of Regulatory Affairs Specialist, based in Irvine, CA. The successful candidate will provide support for the regulatory department to ensure efficient and compliant business processes and environment.

Responsibilities

Assist in SOP development and review.

Provide regulatory input to product lifecycle planning.

Assist in development of regional regulatory strategy and make updates when necessary.

Understand and investigate regulatory history/background of class, disease/ therapeutic/diagnostic context to assess regulatory implications for approval.

Determine trade issues to anticipate regulatory obstacles.

Determine and communicate submission and approval requirements.

Participate in risk-benefit analysis for regulatory compliance.

Monitor applications under regulatory review.

Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.

Assist in preparation and review of regulatory submission to authorities.

Maintain annual licenses, registrations, listings and patent information.

Assist compliance with product post marketing approval requirements.

Assist in the review of advertising and promotional items.

Assess external communications relative to regulations.

Review regulatory aspects of contracts.

Assist with label development and review for compliance before release.

Provide regulatory input for product recalls and recall communications.

Contribute to the development and functioning of the crisis/issue management program.

Ensure product safety issues and product-associated events are reported to regulatory agencies.

Submit and review change controls to determine the level of change and consequent submission.

Skills And Qualifications

Experience in several fields of expertise, including medical writing, advertising, labeling, controlled and restricted substances, import/export and country-specific regulatory support.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Mary Jacobs at ( 1) 2674774800 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Job Requirements

Careers.org gives you access to over a million jobs and career opportunities across the US including in Irvine. Find your perfect job and apply directly through a simply online application process

Company info

ProClinical Ltd
Website : http://www.proclinical.co.uk/

Company Profile
A tier-1 supplier that has made placements into all of the top 10 Pharmaceutical companies, ProClinical has successfully placed over 1000 professionals within brand pharmaceutical, biopharmaceutical, medical device, contract manufacturing and clinical research organisations within the European Life Sciences industry. As well as investing heavily into researching, approaching and contacting new passive candidates, we maintain a large database of candidates worldwide, constantly innovating and adapting to changes within the industry. This means that our consultants are well positioned and well equipped to deliver excellent results to candidates and clients alike. What puts ProClinical ahead of its rivals? Our consultants benefit from having a Life Sciences degree and previous industry experience All our consultants are thoroughly trained in executive search techniques. We invest heavily in generating research data for proactively approaching passive candidates. We have access to the most advanced resources and facilities. We adhere to the REC Code of Ethics as well as our own set of Company Values.

Similar Jobs:
Regulatory Affairs Specialist
Location : Signal Hill, CA
\u003Cp\u003EGrowing medical device company looking for a Regulatory Affairs Specialist to join their team.\u003C/p\u003E\u003Cp\u003E\u003Cb\u003E\u003Cu\u003EResponsibilities\u003C/u\u003E\u003C/b\u003E\u003C/p\u003E\u003Cul\u00...
Regulatory Affairs Specialist Aliso Viejo, CA Job Summary: Regulatory Affairs Specialist is responsible for advising Global Regulatory Management of those situations that may pose a significant risk to the program, quality assuran...
Regulatory Compliance Consultant
Location : Aliso Viejo, CA
Responsibilities: Consult with and advise, associates and leaders in the Life Insurance Division (LID) on legal matters and compliance issues relating to life insurance products, underwriting and servicing. Specifically, support i...
What I liked about the service is that it had such a comprehensive collection of jobs! I was using a number of sites previously and this took up so much time, but in joining EmploymentCrossing, I was able to stop going from site to site and was able to find everything I needed on EmploymentCrossing.
John Elstner - Baltimore, MD
  • All we do is research jobs.
  • Our team of researchers, programmers, and analysts find you jobs from over 1,000 career pages and other sources
  • Our members get more interviews and jobs than people who use "public job boards"
Shoot for the moon. Even if you miss it, you will land among the stars.
ComplianceCrossing - #1 Job Aggregation and Private Job-Opening Research Service — The Most Quality Jobs Anywhere
ComplianceCrossing is the first job consolidation service in the employment industry to seek to include every job that exists in the world.
Copyright © 2018 ComplianceCrossing - All rights reserved. 168