Job#: 2047585
Job Description:
Regulatory & Scientific Affairs SpecialistSummary
As a Regulatory & Scientific Affairs Specialist, you will provide tactical regulatory expertise to help bring Innovation and Renovation projects to the market through cross collaboration with Marketing, Purchasing, Quality and R&D. You will utilize advanced knowledge of regulations along with interpretive skills to minimize negative regulatory impact upon the business.
Essential Duties and Responsibilities
- Gather all raw material documentation.
- Prepare Qualitative and Quantitative ILS to support registrations.
- Review labels for accuracy.
- Review formulation for EU and FDA compliance.
Direct Responsibilities -Production
- Gather and review documentation.
- Prepare final information packet for all formulations and retention.
- Serve as regulatory representative to provide technical expertise, risk assessments, and solutions for product labeling and regulatory issues.
- Participate in cross-functional discussions and communicate compliance information for broad-based labeling, ingredient specifications and claims language.
- Build and utilize knowledge of FDA/EU regulations for cosmetic products.
- Help prepare support documentation and regulatory submissions to FDA and other regulatory agencies.
- Provide tactical regulatory input.
- Upload all required documentation to customer portal.
- Internal and external communications.
Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed 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.
Education/Experience:
A minimum of 2 years in a cosmetic/ pharmaceutical manufacturing environment or appropriate internal training.
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] or 844-463-6178.
Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico.
VEVRAA Federal ContractorWe request Priority Protected Veteran & Disabled Referrals for all of our locations within the state.We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. The EEO is the Law poster is available here.