We are seeking a skilled Regulatory Affairs Specialist to join our team at Pace Pharm. As a
Regulatory Affairs Specialist, you will play a critical role in ensuring compliance with
regulatory requirements and supporting the development and approval of our
pharmaceutical products.
Key Responsibilities
Regulatory Submissions
- Prepare and submit regulatory applications to FDA and other regulatory agencies
- Ensure compliance with regulatory requirements and guidelines
- Collaborate with cross-functional teams to gather and submit required documentation
Regulatory Compliance
- Monitor and interpret regulatory requirements and guidelines
- Ensure compliance with GMP, GLP, and GCP regulations
- Conduct internal audits and inspections to ensure compliance
Product Development
- Collaborate with development teams to ensure regulatory compliance
- Provide regulatory guidance and support for product development
- Review and approve labeling and marketing materials
Inspection and Audit Support
- Prepare for and support regulatory inspections and audits
- Collaborate with quality assurance teams to ensure compliance
- Implement corrective actions and follow-up on inspection findings
Requirements
- Bachelor’s degree or higher in a life science or related field
- Minimum 2-3 years of experience in regulatory affairs or a related field
- Strong knowledge of FDA regulations and guidelines
- Excellent analytical, problem-solving, and communication skills
- Ability to work independently and as part of a team
- Basic computer skills and familiarity with electronic regulatory submissions
- Certification as a RAC or equivalent preferred
Benefits
- Competitive salary and benefits package
- Opportunities for professional growth and development
- Collaborative and dynamic work environment
- Recognition and rewards for outstanding performance
- Comprehensive training and mentorship programs
- Flexible work arrangements and remote work options
- 401(k) retirement plan with company match
- Health, dental, and vision insurance
- Life insurance and disability benefits
- Paid time off and holidays
- Employee stock options
- Professional membership and conference fees reimbursement
- Access to cutting-edge technologies and tools
What We Offer
- A dedicated Regulatory Affairs team to support your professional development
- Opportunities to work on a variety of pharmaceutical products and projects
- A comprehensive regulatory affairs system to streamline your work and enhance productivity
- A collaborative team environment with regular feedback and support
- A chance to contribute to the development of innovative treatments and improve patient outcomes
- A flexible work schedule to accommodate your needs and promote work-life balance
Equal Employment Opportunity
Pace Pharm is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
