RA Associate

AbbVie • North Chicago, IL

2d

About The Position

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.

Requirements

• Bachelor’s Degree in life sciences
• Two years pharmaceutical or industry related experience
• 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

Nice To Haves

• 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

Responsibilities

• 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.
• 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

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level