regulatory affairs senior associate

regulatory affairs senior associate.

• newbury park , california (remote)

• posted today

job details

summary

• $35 - $40.41 per hour

• contract

• high school

• category life, physical, and social science occupations

• reference49410

job details

job summary

As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you!

location: Newbury Park, California

job type: Contract

salary: $35.00 - 40.41 per hour

work hours: 9 to 5

education: High School

responsibilities

• Administrative projects as backup support of Operations staff during project period. Assist US Promotion Regulatory Representatives to support US Promotion Regulatory activities (e.g. Abbreviated Reviews and system updates for label changes, Regulatory Information Management (RIM) archiving and other process documentation authoring support, Veeva data entry and collection).

• Create and maintain records in Veeva and SharePoint. Appropriately archive all regulatory documents and agency communications per process regulatory documentation (e.g. Preclearance & Request for Advisory Comments (RFAC) submissions and other FDA communications).

• Ability to lead and manage Webex meetings and provide meeting minutes. Experience with Jira, Kanban. Creation of Infographics, slides, technical editing of process documents, and proofreading.

• Technical editing of process documents.

• Create PowerPoint, Visio, manipulate data in Excel spreadsheets (including pivot tables) and author/update MSWord documents.

• Experience in labeling and Regulatory document management.

• Experience in promotional review and approval process.

• Previous Company experience is preferred.

qualifications

• Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

• Strong business communication and organization skills

• Detail oriented

• MS-Office applications

• Tableau (preferred)

• Visio

• Veeva PromoMats

• Regulatory experience

• Copy editing

• Technical writing

• Project Management

skills: GCP (Good Clinical Practice), Regulatory Affairs Operations, Regulatory Affairs Strategy, Regulatory Briefing Documents, Submissions

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact ~~~.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

This posting is open for thirty (30) days.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

Qualified applicants in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County's Fair Chance Ordinance for Employers.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.