Director, RA-CMC PAC DM

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. Provides an environment for staff members to develop their careers and take their own leadership positions throughout AbbVie.

Responsibilities

• Leads a global RA CMC PAC DM team who project manages marketed product variations including authoring and compilation of chemistry, manufacturing, and control (CMC) sections to ensure timely preparation of submission documents.
• Devises (or advises their team on) tactical strategies for executing post approval changes with complicated scenarios (e.g., complex dosage form or multiple operational changes, 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 (within or outside of the regulatory groups). Identifies opportunities for process improvements, identifies/solicits solutions and drives for implementation. Ensures enterprise culture initiatives are implemented across the PAC-DM team. 
• Effectively mentors staff to achieve business objectives and staff member personal growth. Reviews and provides feedback on RA training programs.
• Provides leadership to PAC-DM staff by communicating and providing guidance towards achieving department objectives. Identifies engagement needs and partners with stakeholders to implement action plans accordingly. 
• Trains, develops and mentors individuals; includes formal supervisory responsibilities. Evaluates performance of and assists in career development planning for PAC-DM staff.

 

• 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-plus years demonstrated enterprise leadership.  5-plus years in RA or relevant exposure to RA activities.
• Preferred Experience: 10-plus years biopharmaceutical experience including 7-plus years in regulatory affairs, 2-plus 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 Minorities/Women/Veterans/Disabled**

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

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 employee 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. ​

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. 

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