What are the responsibilities and job description for the Regulatory Affairs US Biologicals labeling specialist position at Innova?
A client of Innova Solutions is immediately hiring for a Regulatory Affairs US Biologicals labeling specialist
Position type : Full-time Contract, potential contract to hire
Duration : 12 months
Location : Millsboro Delaware 19966 United States.
Position : Regulatory Affairs US Biologicals labeling specialist
Responsibilities :
- Prepare / revise vaccine packaging labels for regulatory submissions to the USDA, ensuring compliance.
- Support both domestic and international regulatory filing submissions.
- Work with internal teams (Marketing, Pharmacovigilance, Technical Services) to ensure timely label and artwork availability.
- Review and ensure compliance with FDA guidelines and regulations on labeling content, design, and quality checks.
- Maintain regulatory documents and ensure site compliance.
- Train on USDA regulations, ARTIS system, and internal packaging processes.
Qualifications :
Note : Must have experience with FDA guideline compliance, quality checks, and label content review in the pharmaceutical / vaccine industry.
Hybrid (On-site 3 days / week, fixed Tuesday and Wednesday) 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!
Sonam Yadav
PHONE : ( 1) 585-625-4180
EMAIL : sonam.yadav@innovasolutions.com
PAY RANGE AND BENEFITS :
Pay Range
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 centres 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 field
Recent Recognitions :
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, colour, 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.
Salary : $37 - $39
