Director, RA-CMC PAC DM

Job Description The Director Regulatory Affairs for Chemistry, Manufacturing and Controls Post Approval Change Dossier Management (CMC PAC DM) combines scientific, regulatory and business knowledge with superior leadership skills to lead the PAC DM team responsible for ensuring RA-CMC post approval change objectives are met. Builds and maintains partnerships within the Regulatory Affairs functional areas and the Operations and Research & Development (R&D) organizations. Responsibilities Leads a global RA CMC PAC DM team that project‑manages marketed product variations, including authoring and compiling CMC sections to ensure timely preparation of submission documents. Devises (or advises the team on) tactical strategies for executing post‑approval changes with complex scenarios such as complex dosage forms or multiple operational changes and aggressive timelines. Provides leadership to PAC‑DM staff to ensure consistency in the execution of post‑approval changes across all global programs. Provides direction and guidance to direct reports and their teams, as applicable, who exercise significant latitude and independence in their assignments. Designs initiatives to drive business efficiencies across the organization, identifies opportunities for process improvements, solicits solutions and drives implementation, ensuring enterprise culture initiatives are implemented across the PAC‑DM team. Mentors staff to achieve business objectives and personal growth, reviewing and providing feedback on RA training programs. Communicates and provides guidance toward achieving department objectives, identifying engagement needs and partnering with stakeholders to implement action plans. Trains, develops and mentors individuals; includes formal supervisory responsibilities, evaluates performance, and assists in career development planning for PAC‑DM staff. Qualifications Required Education: Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject. Preferred Education: Relevant advanced degree preferred; certification a plus. Required Experience: 10 years biopharmaceutical experience with 3+ years demonstrated enterprise leadership; 5+ years in RA or relevant exposure to RA activities. Preferred Experience: 10+ years biopharmaceutical experience including 7+ years in regulatory affairs and 2+ years supervising employees. Prior experience in the preparation of CMC sections of regulatory dossiers, including electronic submissions. Strong working knowledge of manufacturing unit operations and CTD structure. Strong oral and written communication skills. Strong understanding of the business/enterprise. Ability to work collaboratively with all levels and types of global personnel. Equal Opportunity Employer Equal Opportunity Employer Minorities/Women/Veterans/Disabled AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. Compensation and Benefits Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short‑term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employer remains in the company’s sole and absolute discretion unless and until paid and may be modified at the company’s sole and absolute discretion, consistent with applicable law. #J-18808-Ljbffr