RA Associate

As an individual contributor the Regulatory Affairs Associate Global Submission Support will combine regulatory business and scientific knowledge to provide support with regulatory submissions agency responses and internal queries for AbbVie global product portfolio. Duties include managing end-to-end process for obtaining legalized documents and regulatory samples required by health authorities maintaining data in various systems and tools working with cross-functional partners and project teams and communicating with external organizations companies and vendors. This individual is recognized as very knowledgeable in their discipline and in regulatory affairs submission support for emerging markets.

As an individual contributor the Regulatory Affairs Associate Global Submission Support will combine regulatory business and scientific knowledge to provide support with regulatory submissions agency responses and internal queries for AbbVie global product portfolio. Duties include managing end-to-end process for obtaining legalized documents and regulatory samples required by health authorities maintaining data in various systems and tools working with cross-functional partners and project teams and communicating with external organizations companies and vendors. This individual is recognized as very knowledgeable in their discipline and in regulatory affairs submission support for emerging markets. 

• Serves as primary point of contact with Affiliate Regulatory team for country/region specific document and sample requests to support local regulatory submission activities for new product registrations or to maintain existing product registrations. 
• Assembles information submits applications and serves as point of contact for Health Authorities and other government agencies embassies and consulates to obtain and complete affiliate document requests. Documents may include Certificates of Pharmaceutical Products (CPPs) Certificates of Foreign Government (CFGs) and others. 
• Collaborates with internal teams across AbbVie sites and with Third-Party Manufacturers (TPMs) to obtain documents such as GMP Certificates and Manufacturing Licenses. 
• Communicates and coordinates with external vendors to ensure legalization of documents in accordance with specific country requirements. 
• Manages end-to-end processes of procuring regulatory samples in compliance with established procedures partnering with R&D and Global Operations teams to ensure all steps are completed accurately and on time.
• Maintains up-to-date status tracking in departmental systems and tools; provides regular status updates and may generate reports/dashboards to support delivery timelines and service level metrics; offers input to global teams on submission timelines and deliverables. 
• Manages and coordinates multiple concurrent requests and deliverables to ensure timely execution of tasks with varying business impact; proactively anticipates obstacles and contributes solutions within the team. 
• Participates in continuous improvement initiatives proposing and supporting enhancements to business processes systems and department standards. May contribute to internal projects to update business software. 
• Fosters collaborative positive relationships both internally and externally; influences stakeholders without formal authority to achieve shared goals and meet critical timelines.
• Position accountability: 
• Independently manages and prioritizes daily assignments keeps stakeholders informed on the status of requests and escalates issues as necessary to ensure tasks are completed on time and in accordance with submission deadlines
• Projects are confirmed and assigned by the manager; once assigned independently leads and manages own projects providing regular progress updates and check-ins to ensure alignment with expectations
• May assist in developing training materials and onboarding of new staff

Qualifications :

• Required Education: Bachelors Degree in life sciences 
• Required Experience: Two years pharmaceutical or industry related experience
• Preferred Experience: 2 years in Regulatory Affairs with good understanding of global regulation
• NOTE: Higher education may compensate for years of experience. Years of experience may also compensate for lower education
• Experience working in a complex and matrix environment
• Demonstrated ability to work well with cross-functional and cross-divisional teams. Cross-cultural awareness and ability to work virtually and in a global environment.
• Must maintain collaborative relationships with external partners.
• Maintains awareness of changes to global regulations or timelines and communicates impact to team and partners.
• Experience with Microsoft Office suite especially with Excel Word Power Point and Outlook and SharePoint tools

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 ofthis posting 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 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 anybonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys soleand absolute discretion unless and until 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