Regulatory Affairs Specialist #36737
Pharmaceutical
Houston, TX Direct Hire Jul 30, 2024
Contemporary Staffing Solutions is seeking a visionary Regulatory Affairs Specialist to join our client in Houston, TX! In this dynamic role, you will design regulatory strategies that comply with legal requirements and set new industry benchmarks. Your expertise will ensure that every product developed, manufactured, and distributed meets stringent regulatory standards. This is a mission-driven role, aiming to champion innovation, quality, and accessibility in healthcare, making a significant impact on the lives of many. This Direct-Hire opportunity offers up to $90,000/year!

Key Responsibilities:
  • Ensure compliance with federal, state, and local regulations, including FDA guidelines.
  • Assist in research efforts such as clinical trials and case studies to support product claims.
  • Collaborate on educational materials for both internal and external use.
  • Support onboarding new clinics, maintain clinic relations, and assist in clinical discussions.
  • Investigate, research, and develop new product requests and launches.
  • Prepare and present cross-departmental training on new products.
  • Implement and maintain quality systems and processes with cross-functional teams.
  • Conduct audits and assessments to address compliance gaps.
  • Analyze marketing materials for regulatory compliance.
  • Prepare, review, and submit regulatory documentation.
  • Maintain an updated repository of regulatory documents.
  • Update knowledge base systems regularly.
  • Develop and review Standard Operating Procedures.
  • Stay informed about regulatory changes and provide guidance on their impact.
  • Engage in advocacy efforts and update stakeholders on regulatory landscapes.
  • Communicate with regulatory agencies to resolve issues.
  • Build and maintain relationships with regulatory authorities and trade associations.
  • Collaborate with the Medical Affairs team on projects.
  • Perform other duties as assigned.

Qualifications:
  • Bachelor’s degree in Life Sciences, healthcare, or related field; PharmD preferred.
  • Minimum of 3 years of experience in regulatory affairs within the pharmaceutical or compounding pharmacy industry.
  • In-depth knowledge of FDA regulations and guidelines.
  • Strong understanding of cGMP and pharmaceutical compounding quality standards.
  • Detail-oriented with strong analytical and problem-solving skills.
  • Knowledge of pharmacology and pathophysiology in areas such as Dermatology, IV Therapy, Women’s and Men’s Health, Hormone Replacement, Weight Management, and Fertility.
  • Ability to apply clinical trials and research to product development.
  • Commitment to professional development and staying informed on medical advancements.
  • Proven ability to manage multiple projects and adhere to deadlines.
  • Familiarity with patient education principles and a passion for empowering patients through informative content.

Contemporary Staffing Solutions (CSS) has been a leading provider of contract, temporary, temporary-hire & direct hire solutions. We began as a staffing agency and evolved to a national provider of workforce management solutions with a niche recruitment focus in Accounting & Finance, Call Center & Office, Human Resources, Sales & Marketing, & Information Technology. To learn more about CSS, visit our website: www.ContemporaryStaffing.com.