Highly regarded, industry-leading pharmaceutical company seeks a Regulatory Affairs Specialist to support worldwide regulatory filings and product registrations. The Regulatory Affairs Specialist will work with a variety of new drug products. The Regulatory Affairs Specialist will manage the process life cycle into 510(k) submissions. As a member of the regulatory team you will serve as a key leader driving organizational success within this high visibility, cross-functional global group. The Regulatory Affairs Associate is directly responsible for developing regulatory plans with high level of complexity, participating in development projects, and planning and preparing documentation for international and domestic product registrations for new and modified products.
We are seeking pharmaceutical regulatory affairs specialists who have strong statistical and analytical skills and have strong attention to detail. All regulatory affairs specialist candidates should have a strong background in both domestic and international filings. We offer accelerated career growth potential, and excellent benefits. We have many opportunities and consider only the best candidates to join our highly talented regulatory affairs team.
typical roles and responsibilities for Regulatory Affairs Specialist
- Prepare, submit and maintain regulatory filings with relevant health authorities.
- Prepare, submit and maintain product specific dossiers per local country requirements
- Participate in new product development core teams in the creation of regulatory strategies
- Maintain country specific site registration requirements
- Assist in preparation of documentation for product incident reporting as required.
- Review product labeling
- Review advertising and promotional material
- Utilize and support electronic document management system
- Respond to inquiries from health authorities.
- Review and assess regulatory impact associated with changes made at the manufacturing facilities for multiple region
- Develops internal procedures and tools
- Conducts informational or training sessions as needed
- Organizes and maintains hard copy and electronic department files
- Contributes to management review for new or revised regulations or other quality system activities
- Assists with hosting inspections, as needed
- Assists with conducting internal or external audits
- Assists with resource planning and budgeting
Requirements for the Regulatory Affairs Specialist
- Bachelor's degree, preferably in a technical discipline
- 4+ years regulatory affairs experience in pharmaceutical development
- RAC certification
- A depth of experience in preparing, and submitting regulatory filings, both domestic and international
- Strong analytical, statistical and technical skills
- Strong communications skills, oral, written and electronic
- A strong working knowledge of global regulatory affairs, current guidelines and regulations
- Experience with eCopy for FDA submissions
Salary range for Regulatory Affairs Specialist