Regulatory Affairs Manager - Pharmaceutical Industry

New
  • Location
    Torrance, California
  • Job type
    Direct Hire
  • Category
    Medical & Science - Pharmaceutical - Clinical

Adecco Medical and Science has an immediate need for a Senior Regulatory Affairs Specialist in Los Angeles, CA

Position Summary:

The Regulatory Affairs Specialist’s primary function is to manage the regulatory submission activities to obtain and maintain approvals for conducting clinical investigations and for commercially distributing products worldwide. The Regulatory Affairs Specialist will participate in activities to ensure compliance with worldwide regulatory requirements and must work well under deadlines and have excellent attention to detail.

Duties and Responsibilities:

Prepare submissions (i.e. NDA, MAA, DMFs, etc.) to obtain various worldwide approvals to commercially distribute products.
Support the preparation of applications (i.e., INDs, Protocols, Investigator Brochure) for conducting clinical investigations in the U.S., EU countries and other countries.
Prepare required submissions (progress reports, annual reports, etc.) to facilitate the continuation of clinical studies.
Participate in the review and submission activities (annual reports, periodic safety update reports, etc.) to support the maintenance of marketing approvals.
Support product registrations for international markets as required.
Participate in project development teams and review plans, reports, risk management and design reviews associated with product and process projects.
Perform other duties as assigned.

Skills and Abilities:

Excellent skills in written and verbal communication.
Goal-oriented, proactive, able to multi-task, strong organizational skills.
Literacy with electronic document management systems and experience with electronic submission.
Ability to work through scheduling demands and conflicts with composure and diplomacy.
Interpersonal, communication and negotiating skills.


Minimum requirements:

Bachelor's degree, preferably in a scientific discipline
4+ years of experience in the area of worldwide regulatory affairs in Pre- and Post-Marketing Assessment (both submissions and compliance)
Knowledge and experience of U.S. FDA and EU regulations and standards.
Recent experience in regulatory submission and approval activities with INDs/NDAs/DMFs.
Excellent computer skills, particularly with Microsoft Office products.

II. Complexity of Work:

Requires good verbal and written communication skills, tact, accuracy, and the ability to prioritize work and work well under extreme pressure. Ability to work independently, interface with various levels of administration and management. Must maintain all levels of confidentiality and have a professional, positive attitude towards the job.


If you are interested in this Regulatory Affairs Specialist job in Los Angeles, CA then please click APPLY NOW. If you have questions about the position or would like more information please contact Randy Williamson at 858-812-2601 or by email at randy.williamson@adeccona.com

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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Reference number US_EN_2_108175_327598