Regulatory Affairs Director
4 weeks ago
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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