Associate Director, CMC Dossier Strategy and Leadership

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

Purpose

Describe the primary goals, objectives or functions or outputs of this position.

Leads global regulatory dossier preparation activities by coordinating cross-functional teams of subject matter experts, from internal and external third parties. The primary function is to ensure consistent preparation of drug substance, drug product and analytical sections of regulatory submission documents of high scientific and technical quality that are compliant with global regulatory requirements. Will implement well-defined, efficient processes for preparation, review and approval of these Chemistry, Manufacturing, and Controls (CMC) sections of submission documents. Plays a critical role in ensuring that the CMC submission strategy is aligned closely with the clinical/regulatory development strategy and provide drug development experience and advice as appropriate to the CMC team.

Responsibilities

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

• Author and coordinate submission documentation for all phases of clinical development, with emphasis on later phase programs and marketing applications, often under significant time pressure. Drive team resolution and author responses to questions from regulatory authorities.
• Leverage extensive drug development experience to lead the global cross-functional CMC Team in completion of global regulatory submission documents. Maintain awareness of global regulatory requirements on pharmaceutical development. Ensure necessary changes to regulations are implemented in local practices and procedures.
• Demonstrate excellent interpersonal skills, ability to develop important relationships with exter