Position Description: Regulatory Affairs Specialist

Job Title | Regulatory Affairs Specialist
Location | La Jolla, CA
Department | Regulatory Affairs

Summary

This position will assist with the preparation and submission of regulatory documents and will provide support of the regulatory function with respect to database management, maintaining regulatory files and licenses, and assisting on assigned projects as needed. May prepare reports or specific sections of INDs, IDEs, CTAs, PMAs, BLAs or other regulatory documentation under supervision. May submit submissions or variances for changes for labeling, manufacturing, marketing, or clinical protocols. Keeps abreast of regulatory compliance issues and assist in developing new Regulatory Dept. procedures. This individual will maintain registrations and licenses for the company and will prepare periodic reports as directed by the department head.

Essential Duties and Responsibilities

The duties and responsibilities of this position include the following, although other duties may be assigned.

• Assists and supports Regulatory team with projects associated with product submissions development. Performs the coordination and preparation of document packages for regulatory submissions and interfaces with various functional areas to collect relevant information, test reports, and technical discussions.
• Compiles all materials, prepares and submits applications for relevant State and federal licensing and registrations, and annual reports. Researchs international and domestic regulatory issues.
• Maintains regular communication with team members to facilitate international registrations and approvals.
• Other duties and responsibilities that may be assigned from time to time. This may include review of labeling and promotional materials, maintenance of complaint files and attendance at meetings as the regulatory representative.
• Support the development and review of documentation and procedures to support the regulatory function.

Supervisory Responsibilities

Position has no supervisory responsibilities.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Must also possess the following qualifications:

• Must have strong computer skills and be proficient using network software
• Should possess strong writing and verbal skills
• Must be well-organized, and be able to adapt to changing priorities and deadlines
• Must be flexible in work assignments - can involve collaborative team settings to specific individual projects
• Ability to comprehend and interpret material and issues of a scientific or technical, and communicate those facts and concepts verbally and in writing
• Must be responsive to requests from international colleagues
• Must demonstrate ability to work independently
• Must represent the regulatory function with integrity and professionalism
• Certificate in Regulatory Affairs, US or EU RAC Certification mandatory for those without direct regulatory experience.

Education and Experience

High school diploma or equivalent; BA/BS in life or health science desirable. 0 to 2 years of regulatory or related experience in a biotech or medical device company. Familiarity with U.S. FDA medical device and/or drug approval process. This should include a general understanding of applicable regulations. Understanding of GMPs and GCPs would also be helpful.

Language Skills

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

Mathematical Skills

Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry.

Reasoning Ability

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Certificates, Lienses, Registrations

Certificate in Regulatory Affairs, US or EU RAC Certification mandatory for those without direct regulatory experience.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

May include standing at photocopier and some light lifting (up to 10 lbs.) when working on regulatory submissions. Involves working in normal office environment. Some travel may be required up to 5%.

We offer a competitive benefits & compensation package!

All qualified resumes should be submitted directly to careers@abh.com

We are an Equal Opportunity Employer.