Company

American CybersystemsSee more

addressAddressNewark, CA
type Form of workContractor
CategoryInformation Technology

Job description

Innova Solutions is immediately hiring for a Regulatory Affairs Specialist
We are seeking a talented Regulatory Affairs Associate with expertise in labeling to join our Regulatory Affairs team. The successful candidate will play a crucial role in ensuring compliance with regulatory standards and guidelines related to product labeling. This position offers an exciting opportunity to contribute to the development and commercialization of life-changing therapies in a dynamic and collaborative environment.
Responsibilities:
Develop and maintain regulatory documentation for product labeling, including package inserts, patient leaflets, and labeling supplements.
Ensure compliance with regulatory requirements, including FDA regulations and international labeling guidelines.
Collaborate with cross-functional teams to review and approve labeling content for new product launches and product updates.
Manage labeling-related submissions to regulatory agencies and respond to inquiries as needed.
Stay informed about changes in regulatory requirements and industry best practices related to labeling.
PAY RANGE AND BENEFITS:
Pay Range*: $50-60/hr
*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.
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.

Refer code: 8691630. American Cybersystems - The previous day - 2024-03-23 05:36

American Cybersystems

Newark, CA
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