Regulatory Affairs Labeling Specialist

Summary:

The Regulatory Labeling Specialist is responsible for providing independent regulatory review of labels and labeling proposed for publication. Guides conformance with applicable regulations in product development, support of claims, content and format of labeling, and promotional materials and helps to define data and information needed for corporate regulatory approval in conjunction with cross-functional product development teams to support business objectives in a timely manner.

Responsibilities:

• Prepares Target Product Information Profiles for new products and label revisions for regulatory approval.
• Prepares reviews of label and labeling artwork proofs against regulatory requirements for final approval.
• Executes regulatory research plans of label indications, warnings and limitations.
• Conducts research in other regulatory and quality topics as requested.
• Communicates with Global Regulatory Team.
• Reviews promotional labeling for compliance with approved labeling and other applicable requirements.
• Supports primary and secondary claim substantiation research.
• Manages documentation of regulatory reviews.
• Helps to manage projects relating to product claims and labeling.
• Maintains regulatory review calendar.
• Maintains regulatory review metrics.
• Communicates status of regulatory reviews verbally and in writing to stakeholders.
• Represents the regulatory affairs department on specific projects.
• Monitor, evaluate and recommend improvements to labeling review process.
• Monitor changes in labeling requirements in the US.
• Develops SOPs relating to product label development topics and the processes by which labels are created and revised.
• Participates in inter-departmental meetings.
• Other duties as assigned.

Requirements:

• Bachelor’s degree or Equivalent
• 1 to 3 years of experience in pharmaceutical labeling development
• Excellent communication skills (verbal, written).
• Ability to work independently.
• Individual must be detail oriented and have strong prioritization skills