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Regulatory Affairs Director

2 months ago

Reston, Virginia, United States Proclinical Staffing Full time

Job Title: Regulatory Affairs Director

Job Summary:

Proclinical Staffing is seeking an experienced Regulatory Affairs Director to join our team. As a key member of our organization, you will be responsible for developing and implementing regulatory strategies for our clients in the pharmaceutical and biotechnology industries.

Key Responsibilities:

  • Regulatory Strategy Development: Develop and implement regulatory strategies for our clients' development programs, ensuring compliance with relevant regulations and guidelines.
  • Regulatory Submission Preparation: Prepare and submit regulatory documents, including INDs, NDAs, and MAAs, to regulatory authorities.
  • Regulatory Authority Interactions: Collaborate with regulatory authorities to resolve queries and address concerns related to our clients' products.
  • Regulatory Compliance: Ensure that our clients' products comply with relevant regulations and guidelines, including GMP, GCP, and GLP.
  • Team Leadership: Lead and mentor a team of regulatory professionals, providing guidance and support to ensure successful project delivery.

Requirements:

  • Education: Bachelor's degree in a life science, chemistry, or chemical engineering, or a closely related field.
  • Experience: At least 10 years of experience in pharmaceutical regulatory affairs, including CMC regulatory affairs.
  • Skills: Strong knowledge of regulatory guidelines and regulations, including GMP, GCP, and GLP. Excellent communication and leadership skills.

What We Offer:

  • Competitive Salary: A competitive salary and benefits package.
  • Opportunities for Growth: Opportunities for career growth and professional development.
  • Collaborative Environment: A collaborative and dynamic work environment.

About Proclinical Staffing:

Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.