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Detailed Description

Job Description

Leading, initiating, reviewing and approving strategies for non-promotional and promotional materials to comply with regulatory requirements throughout the product life-cycle. The candidate will be responsible for ensuring compliance with regulatory agencies requirements and meeting strategic promotional, medical, and corporate communications objectives. Additional responsibilities will include monitoring regulatory compliance trends in industry and interpreting new regulations and guidance documents. Coordinate regulatory training of commercial and marketing teams on regulatory issues pertaining to advertising, promotion, and product launch activities . The individual will work collaboratively with medical affairs, legal, compliance, and commercial teams in the development and implementation of advertising and promotional processes and materials for the company(ies) product portfolio that support the achievement of business objectives. Will provide insight, sound judgment and clear directions on programs and tactics (both promotional and non-promotional) that are compliant with regulations and company policies.

Key Responsibilities Include

• Maintain a deep and current awareness of evolving US regulations and guidelines, enforcement actions and policy issues affecting the pharmaceutical/biotech Industry
• Provide regulatory input into the development, review, approval, and implementation process for promotional and non-promotional materials review in a cross-functional environment
• Effectively partner with Medical Affairs, Legal, Compliance, Commercial, and other stakeholders as needed to ensure that promotional and non-promotional materials and are reviewed in a timely fashion throughout the product life-cycle
• Interpret and communicate regulatory perspective on promotional and non-promotional activities and risks to all stakeholders and management
• Ensure communications and promotional claims are consistent with product registrations, applicable laws, regulations and policies and have sufficient substantiating evidence
• Undertake and coordinate regulatory training of company personnel on regulatory issues pertaining to advertising and promotion activities
• Understands broad concepts within Regulatory Affairs and potential implications across the organization
• Provides product development and label development strategies, as needed, to ensure promotional claims can be supported
• Serves as supportive liaison with FDA reviewers in the request and negotiation of advisory comments and any other interactions regarding the use of claims for product/indication
   

Qualifications

• Bachelor's degree required. Advanced degree Pharm.D, J.D., M.D.  preferred.
• a minimum of 5 years Regulatory Affairs experience in advertising and promotion
• Experience working with OPDP a plus.
• Thorough knowledge of US regulatory requirements pertaining to marketing authorization filings for new products or updates to existing products particularly related to advertising and promotion
• Knowledge of global drug/biologic regulations and standards particularly related to promotion including but not limited to EU and international Requirements is a plus
• Ability to work in a fast-paced, technically challenging environment where drive is critical to success
• Effective interpersonal skills with strong organizational skills
• Ability to assess areas of regulatory risk and effectively communicate and coordinate discussions to influence across all business functions in order to reach resolution
• Strong writing, project management and communication skills
• Proficiency in Microsoft Office and electronic document management systems.