Regulatory Affairs Director

4 weeks ago


Harrisburg, Pennsylvania, United States J&J Family of Companies Full time

Job Title: Regulatory Affairs Director

Job Summary:

We are seeking a highly skilled Regulatory Affairs Director to join our team at J&J Family of Companies. As a key member of our regulatory team, you will be responsible for developing and implementing regulatory strategies to ensure compliance with global regulations and guidelines.

Key Responsibilities:

  • Develop and implement regulatory strategies to ensure compliance with global regulations and guidelines
  • Lead the preparation of regulatory dossiers for submissions to US FDA
  • Collaborate with cross-functional teams to ensure regulatory strategies align with business objectives
  • Provide regulatory input to clinical development programs, risk/benefit assessments, and medical affairs programs
  • Ensure compliance with internal and external policies and legislation

Requirements:

  • Minimum of 8 years' experience in pharmaceutical industry, medical device industry, consumer industry, or health authority regulated industry
  • At least 6 years of Regulatory Affairs experience required with focus on the NA region and FDA
  • Solid understanding of WW HA laws (with a focus on FDA), regulations, guidances, and regulatory submission routes available for new study drugs
  • Ability to maintain knowledge of competitors in the therapeutic area and what they are doing in early/late development and knowledge of labeling aspects

Preferred Qualifications:

  • Experience or training in Neuroscience or more specifically, Neuropsychiatry
  • Proven track record of encouraging the long-term learning or development of others

What We Offer:

  • Competitive salary range: $157,000 - $271,400
  • Annual performance bonus
  • Comprehensive benefits package, including medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance
  • Retirement plan and savings plan (401(k))
  • Time off benefits, including vacation, sick time, holiday pay, and work, personal, and family time

Location: NA-US-New Jersey-Titusville, NA-US-Pennsylvania

Organization: Janssen Research & Development, LLC (6084)

Job Function: Regulatory Science



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