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Invivyd · 1 day ago

Senior Director, Regulatory Labeling, Advertising and Promotion

New Haven, CT (Northeast Preferred)

Full-time

Hybrid

Director/Executive

10+ years exp

Invivyd is a company dedicated to delivering protection from serious viral infectious diseases, particularly for immunocompromised individuals. The Senior Director of Regulatory Labeling, Advertising and Promotion will lead the review and approval of promotional materials and manage global labeling, ensuring compliance with regulatory requirements and corporate objectives.

BiotechnologyPharmaceuticalTherapeutics

Responsibilities

Represents Regulatory Affairs as a member of cross-functional commercial review committee, providing regulatory input into the review and approval of promotional and nonpromotional materials

Maintain a deep and current awareness of evolving US and global regulations, Codes and guidelines, enforcement actions and policy issues affecting the pharmaceutical/biotech Industry as it pertains to labeling and promotion

Effectively partner and collaborates with Medical Affairs, Legal, Compliance, Commercial, and other stakeholders as needed to ensure that promotional and non-promotional materials are reviewed in a timely fashion throughout the product life cycle

Primary Liaison with OPDP and effectively manages relationships with FDA contacts

Lead the labeling process, including CCDS, and support systems for new or changes to existing commercial labels are made

Provide strategic regulatory advice for labeling taking into consideration marketing use post-approval

Interpret and communicate regulatory perspective on promotional and non-promotional activities and risks to all stakeholders and management

Coordinate regulatory training on regulatory issues pertaining to advertisement and promotion activities

Qualification

Regulatory AffairsPharmaceutical Industry ExperienceLabeling KnowledgeOPDP ExperienceGlobal Regulations KnowledgeProject ManagementWriting SkillsCommunication SkillsFast-paced Environment Adaptability

Required

Doctorate, Master's, or Bachelor's degree in a relevant/scientific discipline (graduate degree preferred)

Minimum of eight years working in the pharmaceutical or biotech industry with a minimum of 10-15 years in Regulatory Affairs

Experience working with OPDP

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 US regulations for labeling

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 environment where drive is critical to success

Ability to assess areas of regulatory risk and effectively communicate and coordinate discussions to influence all business functions in order to reach resolution

Strong writing, project management and communication skills

Ability to travel as needed (likely 1x a month) to our New Haven, CT office