Regulatory Affairs Senior Specialist

Regulatory Affairs Manager

Plan and prepare regulatory submissions of therapeutic products and medical devices. Utilizing good understanding of regulations for therapeutic products and medical devices, interpret regulations and provide regulatory strategies and recommendations. Support registrations, lifecycle management activities and ensure regulatory compliance is maintained. Monitor emerging trends regarding industry regulations to determine potential impact on organizational processes.

Core Job Responsibilities :

Regulatory :

• Keep up to date for product registration, variation, line extension and other related legislations and regulations knowledge for therapeutic products and medical devices.
• Monitor and disseminate information on changes by the local Regulatory Authority including legislations and regulations affecting registration, manufacture, distribution, sale and marketing of AbbVie products.
• Facilitate communication between Area Regulatory Lead, Affiliate Brand Team and the local Regulatory Authority.
• Update local RA SOPs following updates to regulations and processes and conduct periodic review of these SOPs.
• Streamline RA processes to increase productivity.
• Maintain good knowledge of relevant corporate policies and ensure compliance.
• Other regulatory projects and tasks assigned by RA Manager.

Product registration and approval :

Product maintenance :

Support marketing activities :

Qualifications :

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

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

abbvie.com / join-us / reasonable-accommodations.html