Company Description 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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description + Managing Regulatory Submissions: Prepare regulatory submissions to obtain necessary regulatory approvals. + Developing RA Strategies: Independently assess timelines and lead in developing regulatory strategies for new assets and line extensions. Assist RA manager or director in strategy development. + Resolving Regulatory Issues: Identify and resolve regulatory issues and challenges that may arise during product development, registration, or post-market phases. + Collaborating with Cross-Functional Teams: Work with R&D, Quality Assurance, and Marketing to gather necessary information and support regulatory affairs activities. + Problem-Solving and Decision Support: Participate in discussions and provide input on regulatory matters to support decision-making processes. + Managing Variations: Set up timelines for managing variations in accordance with set strategies. + Compliance Review: Review and evaluate product labeling, packaging, and promotional materials for compliance with regulatory requirements. + Research and Stay Updated: Conduct research and stay updated on changes in regulations and guidelines as a Subject Matter Expert (SME). + Impact Evaluation: Evaluate cross-functional team impact, implementation plans on marketed products, risk management, and problem-solving. + Strategy Implementation: Reflect cross-functional feedback and global strategy in product discontinuation, withdrawal, co-promotion, or co-marketing strategies. + Contract Review: Thoroughly review contract terms and conditions for regulatory implications. + Pioneering New Projects: Lead new regulatory projects like combination products, gene therapy, and OTC products. + Supervision: Supervise projects for regulatory matters of team members. Qualifications + University degree, more than 7 years of experience in a regulatory position, and proficiency in both spoken and written English + Having experience in pipeline management/ assessment with proven track records + The candidate is expected to maintain high ethical standards and observe AbbVie's code of conduct and business integrity. + Industry from pharmaceutical companies is ideal 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