Regulatory Affairs Associate I at American Cybersystems, Inc. in Fremont, California

Job Description:

A client of Innova solutions is immediately hiring for a Regulatory Associate I

Position type: Full-time Contract
Duration: 20+ months
Location: Fremont California 94555 USA


Job Description:

• Assist in preparing responses to global information requests and related maintenance documentation (amendments, supplements, annual reports, safety reports, etc.) within a defined time schedule.


• Help determine regulatory strategies for manufacturing changes and regulatory activities.


• Aid in preparing Lifecycle Management like Annual Reports (Product, DMF).


• Coordinate and track workflows for regulatory submissions.


• Ensure regulatory submissions meet global standards.


• Participate in meetings and interact with project team members and sub-teams.


• Assist with and eventually lead licensing activities and required updates (Establishment Registration, California State License, State licensing).


• Support reporting requirements under the CARES Act.


• Provide support to Regulatory management as needed.

Skills:

• PC literacy is required.


• Proficiency in technology use, including MS Office skills (Outlook, Word, Excel, PowerPoint, MS Project),


• Document Management Systems and Internet resources, is expected.


• General knowledge and application of global regulations and cGMP requirements are necessary.


• Must be able to work independently and with appropriate supervision.


• Excellent organizational, interpersonal, and communication skills (oral and written) are required.

Education:

• A Bachelors degree in a scientific field, preferably Chemistry or Pharmacy, with 1-3 years of experience, or a Masters


• Degree in Regulatory Affairs with a minimum of 3 months of regulatory experience (internship) is required.

Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.
We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW.
Thank you!

Ramesh Tummala
Lead - Recruitment
PHONE (678-648-7395)
EMAIL (ramesh.tummala@innovasolutions.com)

PAY RANGE AND BENEFITS:
Pay Range*: Pay Range: $34.00 - $36.00 per hour.
*Pay range 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.

Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).

ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.

Recent Recognitions:

Named One of America's Best Employers for New Grads by Forbes (2024
Named One of the Best Companies to Work For by U.S. News & World Report (Private Companies List, 2024-2025)
One of the Largest IT Staffing Firms in the US - Ranked #3 by Staffing Industry Analysts (SIA, 2024)
One of the Largest Staffing Firms in the US - Ranked #13 by Staffing Industry Analysts (SIA, 2024; includes Innova Solutions, Volt, & HireGenics)
Named One of the Top Ten Private Companies in Atlanta by the Atlanta Business Chronicle (2023)
One of the Largest Certified Minority Business Enterprises (MBEs) in the United States (NMSDC, 2024)
AWS Advanced Tier Services Partner with 100+ certifications

Website: https://www.innovasolutions.com/

Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at hr@innovasolutions.com or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b.

The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws. Apply Now