Senior Manager, CMC

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines 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, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

This Senior Manager (RACMC) position will provide tactical and strategic leadership on complex projects within the Regulatory Affairs Chemistry, Manufacturing, and Controls (RACMC) organization by actively contributing to the development and implementation of global CMC regulatory strategies throughout the lifecycle of pharmaceuticals and drug-device combination products. Our team supports a dynamic portfolio consisting of both clinical and commercial products in diverse therapeutic areas, most of which have a global footprint.
Main Areas of Responsibilities
• Drive global technical regulatory strategy development and implementation for multiple complex products and programs. Identify related risks and develop and implement risk mitigations, while anticipating regulatory responses and preventing downstream challenges through scenario and contingency planning.
• Guide and influence technical groups in areas of product development and lifecycle management regarding both drugs and drug-device combination products. Participate in potential and established third party efforts (i.e. due diligence activities, joint ventures, etc.).
• Collaboratively interact with regulators and internal and external stakeholders regarding complex, high-visibility, and high-risk projects to ensure alignment with and progress towards key Regulatory Affairs CMC business objectives.
• Represent AbbVie and the RACMC department by acting as a primary contact with regulatory authorities, including in the planning and leadership of complex health authority interactions, and regarding the authoring, review, and submission of complex CMC/Quality supplements and variations.

Qualifications

• B.S. required in chemistry or other scientific discipline with a minimum of 4 years of regulatory experience. MS degree and 3 years of regulatory experience. PhD or equivalent and 2 years of regulatory experience.
• Pharmaceutical development and lifecycle management experience.
• Robust critical thinking, writing, communication, presentation, and project management skills.
• Ability to interpret and apply global CMC/Quality drug and medical device regulations and guidance documents to supported programs, products, and cGMP changes to ensure fully compliant submissions, regulatory dossiers, and project plans.
• Capacity to quickly and accurately define technical data and information requirements necessary to obtain first-pass global regulatory CMC approvals regarding supported submissions and project plans.
• Ability to independently lead the preparation, review, and submission of high-quality, globally complex CMC supplements and variations, and to document submissions and follow-up appropriately.
• Prior leadership experience in providing robust RACMC representation to internal and external stakeholders, including health authorities, both in small settings and in the context of large, cross-functional or matrixed project teams.
• Strong background in implementing and influencing evolving departmental policies to assure ongoing compliance regarding global regulatory requirements, and in cross-functionally managing the resolution of diverse challenges regarding RACMC risks and strategies.
• Willingness to mentor less experienced colleagues regarding the above.

Job Type
Standard

Schedule
Full-time

Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.