Director, Regulatory Affairs Information Management

The Director of Regulatory Information Management (RIM) leads the advancement of business capabilities to enable efficient consistent and compliant use and management of Regulatory information across AbbVie and with Health Authorities. Provides strategic design implementation and ongoing improvements of Regulatory business capabilities. In addition the individual is generally considered a key opinion leader and an expert resource both within AbbVie and externally. The individual may influence changing regulations and guidance interface with outside regulatory agencies and provide executive management with RIM metrics and reports. 

• Proposes and executes enhancement within the Regulatory Information Management vision. Provides strategic design development and implementation plans for the RIM Solution (Cosmos) and works alongside BTS Business SMEs and stakeholders to propose and lead the execution of these plans.
• Provides strategic design implementation and ongoing improvements of Regulatory business capabilities and works closely with Regulatory Business Process Owners and other internal partners to identify prioritize and deliver sound RIM processes and supporting technologies in support of Regulatory strategies.
• Leverages a working knowledge of Regulatory business processes across the complete drug product lifecycle including A&A Safety Clinical Development PDS&T Quality and Operations to transform improvement concepts into executable initiatives. Seeks input from and forges agreements among sponsors regarding initiative goals and objectives across multiple domains to drive benefit across the enterprise.
• Oversee the implementation and maintenance of robust data to ensure the accuracy consistency and integrity of regulatory information. Lead ongoing data review and improvement initiatives and collaborate with cross-functional teams to resolve discrepancies and ensure compliance with regulatory requirements.
• Drive continuous improvement of the Regulatory Information Management (RIM) system by maintaining deep expertise in its functionality and user needs. Advance RIM solutions optimize supporting materialsincluding training programs and job aidsand provide effective training to staff. Represent RIM in internal and external forums including staff meetings regional meetings and conferences.
• Define key performance indicators (KPIs) and metrics to measure the success and impact of ongoing activities and innovation efforts regularly reporting progress to leadership. 
• Leverage expertise and ownership of Regulatory Information to support inspections.
• Effectively frames complex issues for decision-makers. Prepares and delivers effective presentations that lead to actionable results. Draws upon personal knowledge of RA business processes global regulations and process improvement methods to propose and design innovative business process improvements.
• Works independently in a role that demonstrates organizational influence within or across Regulatory and partner functions.
• As applicable identifies and leads project team members effectively without direct authority; motivates to drive performance resolve conflicts and mitigate risks.

Qualifications :

Required Education:

• Bachelors degree in business management information systems engineering math science (e.g. biology chemistry pharmacy medical) or related field

Required Experience:

• 12 years pharmaceutical device or industry related experience
• 5 years of experience leading a team
• Previous Life Science leadership role with strong management skills
• Strong communication skills both orally and written
• Strong business acumen and negotiating skills
• Experience working in a complex and matrix environment
• Ability to craft compelling business cases and sell new ideas
• Proficiency in project planning and management experience including successful implementation of complex initiatives.

Additional Information :

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 thisposting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic locationand 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 long-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 commissionincentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless anduntil paid and may be modified at the Companys 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. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time