at AbbVie in North Chicago, Illinois, United States
Job Description
Purpose:
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. Responsibilities:+ Serves as primary interface 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 in order to obtain and complete affiliate document requests. Documents may include Certificates of Pharmaceutical Products (CPPs), Certificates of Foreign Government (CFGs) and others.
+ Works directly with internal partners from all AbbVie sites and Third-Party Manufacturers (TPM) to obtain required documents such as GMP Certificates and Manufacturing Licenses.
+ Liaises with vendors to communicate and coordinate legalization of documents in accordance with country requirements.
+ Works directly with partners including QA Operations organization, to support procurement of regulatory samples following well established processes.
+ Provides regular updates on the status of the requests and maintains departmental tools for accurate tracking. May create reports and dashboards to support delivery against timelines and service level performance. May provide input to global product teams on submission timelines and deliverables.
+ Expedites, manages, and coordinates multiple concurrent requests and deliverables to meet required timelines for activities with low to moderate business impact. Anticipates obstacles and proposes solutions within the team.
+ Contributes to the development and implementation of optimal business processes and standards within the department to ensure high levels of customer support. Suggests and contributes to process improvements, including changes to software and business processes. May participate on internal project teams to update business software.
+ Demonstrates ability to influence without direct authority. Builds and maintains positive relationships internally and externally.
+ Position accountability/scope:
+ Accountable for independently completing and prioritizing daily assignments
+ Receives projects from manager but has responsibility for managing own projects with oversights
+ Reviews project progress with manager on a regular basis and escalates issues
+ May assist with developing training materials and onboarding staff
Qualifications:+ Required Education: Bachelor’s Degree in life sciences
+ Required Experience: 2 years pharmaceutical or industry related experience
+ Preferred Experience: 2 years in Regulatory Affairs with good understanding of global regulations
+ NOTE: Higher education may compensate for years of experience. Years of experience may also compensate for lower education
AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.
