Regulatory Affairs Specialist

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 at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

Support the execution of regulatory activities for products within the assigned portfolio, in compliance with local regulations, approved plans, and company policies.

Contribute to the timely preparation, submission, follow-up, and maintenance of regulatory applications, including product registrations and lifecycle management activities.

Support the management of complex or high-impact regulatory matters in collaboration with senior Regulatory Affairs colleagues, progressively increasing technical knowledge, accountability, and independence. Support regulatory compliance and business continuity, helping to minimize supply interruptions and risks that could affect patients or product availability.

• Prepare and support submissions for new marketing authorizations, variations, renewals, notifications, and other lifecycle management activities for the assigned portfolio.
• Maintain product licenses and regulatory documentation in accordance with local requirements, approved product information, supply needs, and internal procedures.
• Perform assigned activities in alignment with applicable standard operating procedures and regulatory requirements.
• Support routine interactions and follow-up with local regulatory authorities. Escalate complex questions or issues to senior team members or the Regulatory Affairs Manager.
• Assist in preparing accurate and timely responses to health authority questions and requests.
• Support completion and tracking of post-approval commitments within required timelines.
• Contribute to the prepatarion of regulatory documentation and  provide operational support for new product applications and launches.
• Review promotional and non-promotional materials for regulatory compliance, following regulations and established review processes and guidance.
• Support labeling, prescribing information, and packaging component implementation to maintain alignment with approved information and local regulations.
• Maintain regulatory databases, trackers, records, and submission documentation accurately and on time.
• Provide regulatory support to cross-functional activities involving Medical, Commercial, Market Access, Quality, Supply Chain, and other relevant functions.
• Monitor regulatory updates, communicate relevant changes to the team, and support assessment of their potential impact.
• Organize priorities, identify risks or delays, and provide timely status updates to the manager and relevant stakeholders

Qualifications

• University degree in Pharmacy or related careers with equivalent experience. A related health sciences degree may be considered where permitted by local requirements.
• Intermediate English proficiency, typically equivalent to B1-B2. Able to read and understand regulatory documents, participate in routine meetings, and prepare clear written communications with support when needed.
• Typically 2-3 years of experience in Regulatory Affairs within the pharmaceutical industry. Relevant internship or trainee experience may be considered as part of the overall profile.
• Practical exposure to drug product registrations, lifecycle management activities, variations, renewals, or regulatory maintenance processes.
• Working knowledge of local regulatory requirements and submission processes.
• Ability to prepare and review regulatory documentation with attention to detail and guidance from more experienced colleagues.
• Good written and verbal communication skills, organization, follow-up, and ability to manage several assigned activities.
• Ability to collaborate effectively in cross-functional teams and to escalate risks or uncertainties appropriately.
• Experience using regulatory databases or electronic document management systems is desirable.

Additional Information

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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html