OWP Pharmaceuticals

Compliance

• Performs daily labeling functions in Regulatory Affairs, including creation of draft labeling, revision of current labels, and FDA deficiency letters.
• Creation and maintenance of all SPL (Structured Product Labeling) and PLR (Physician's Labeling Rule) files to ensure accurate rendering for all products.
• Makes strategic and critical decisions regarding patents, carve-outs, and labeling content.
• Assesses labeling processes and practices for efficiency and continual improvement.
• Formats/develops labeling annotations and deficiency responses.
• Meets deadlines and goals in a timely manner.
• Proofreading and annotating label copy to the highest quality standards.
• Ability to document changes and justification by developing and creating change controls.

Senior Associate, Regulatory Affairs – Labeling

• Manages the end-to-end MLR process for submitting (requesting), reviewing, and approving promotional materials, ensuring they are compliant with regulations (the Code of Federal Regulations (CFR), FDA guidance, PhRMA Guiding Principles, etc.) and approved company policies and procedures.
• Establishes strong working relationship with cross-functional review and supporting team members (internal and external), to facilitate feedback and approvals.
• Aligns and maintains effective communication channels with key counterparts, Marketing, Corporate Strategy, Medical Affairs, Legal and Compliance as well as external partners and consultants.
• Makes challenging decisions based upon sound regulatory knowledge or makes appropriate assessment for elevating to upper management for further consideration.
• Approve FDA submission for Advertising and promotions, such as 2253 forms.
• Works closely with RA labeling group regarding label changes and packaging insert changes to ensure the promotional Prescribing information (PI) and ISI (important Safety Information) are updated as appropriate.
• Maintain accurate records of submissions, approvals, comments, and version control for audit purposes.
• Help identifies and address bottlenecks in the review process and may contribute to developing playbooks or best practices.
• Identifies areas of improvement in process, policy, develop recommendations and leads initiatives.
• Proactively captures and disseminates activities of government, industry, and trade associations that impact pharmaceutical regulatory policies.
• Maintains awareness of pending changes to communicate impact and relevance to the relevant teams.

Senior Associate, Regulatory Affairs – Labeling

Senior Manager, Regulatory Affairs – Advertising and Promotions