Director, RA-CMC PAC DM

Company Description

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 atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

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 ensuringRA-CMC post approval changeobjectivesare 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.
  
  
  

Qualifications

• Required Education: Bachelors 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 operationsand 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**

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipatein our short-term incentiveprograms.
  
  
  

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless and until paid andmay bemodifiedat the Companys sole and absolute discretion, consistent withapplicable 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.

US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

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