Job Summary: The Regulatory Affairs Specialist/Sr.
Specialist is responsible for managing and overseeing the development, and review
of regulatory documents / deliverables / packages to ensure compliance with FDA
requirements for the US market. This role involves working closely with
cross-functional teams to support submission, review and product launches while
maintaining ongoing compliance throughout the product lifecycle in alignment
with Long Grove style guidelines.
Department: Regulatory Affairs
Reports To:
Regulatory Affairs Manager / Director /Vice President
Key
Responsibilities:
·
Assist
with the preparation and timely submission of New Product Applications, Annual
Reports, Periodic Adverse Events Reports (PADERs), Promotional Materials (OPDP)
and other post-marketing requirements to appropriate regulatory agencies (Primarily
US FDA).
·
Assess
the appropriate regulatory reporting mechanism using FDA regulations, guidance
documents, and in-house policies upon review of Change Control Documentation.
·
Work
closely with Regulatory Affairs, Quality Assurance, Marketing, and Product
Development teams to gather information and ensure that all of regulatory
documentation for new products, changes to existing products, and post-market
activities are compliant.
·
Review
and provide guidance on product labeling, structured product labeling (SPL), promotional
materials, and other product documentation to ensure compliance with regulatory
requirements.
·
Development/maintenance
of Regulatory trackers and databases.
·
Monitor
and track regulatory submission timelines and communicate updates to relevant
stakeholders.
·
Stay
current with changes in regulations, guidelines, and industry best practices
related to pharmaceuticals. Interpret and apply regulatory requirements to
ensure product submissions are accurate and compliant along with monitoring Drugs@FDA
website to align with RLD updates.
Qualifications:
Education: Bachelor’s degree in Life Sciences,
Regulatory Affairs, Chemistry, or a related field. Advanced degrees or
certifications in Regulatory Affairs (e.g., RAC) are a plus.
Experience: Minimum of 3-5 years of experience in
regulatory field within the pharmaceutical, biotechnology, or medical device
industry. Current knowledge of FDA guidelines (CFR 21).
