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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 Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

PRIMARY OBJECTIVE

To manage the preparation of regulatory submissions of company products in order to obtain necessary regulatory approvals

To provide regulatory input on regulatory matters to company personnel.

CORE JOB RESPONSIBILITIES

• Assist RA Manager or Director in developing RA strategies - independently assess timeline and lead to develop regulatory strategy for new assets and line extension (new indications, new formulation and etc) based on the regulatory requirements as well as reflecting cross-functional team (CFT) considerations.

• Identifying and resolving regulatory issues and challenges that may arise during the product development, registration, or post-market phases

• Collaborating with cross-functional teams, such as R&D, Quality Assurance, and Marketing, to gather necessary information and support regulatory affairs activities.

• Participating in problem-solving discussions and providing input on regulatory matters to support decision-making processes.

• Set up timeline on managing variations in accordance with already set strategy and timeline

• Reviewing and evaluating product labeling, packaging, and promotional materials to ensure compliance with regulatory requirements.

• Conducting research on regulatory requirements and staying updated on changes in regulations and guidelines as SME

• Evaluation CFT impact, implementation plan on the marketed products (hurdle, current situation) risk management, problem solving

• Product discontinuation/withdrawal/MAT/co-promotion/co-MKT strategy reflecting CFT feedback and global strategy

• Conducting thorough reviews of contract terms and conditions to identify any regulatory implications or requirements that need to be addressed.

• Be pioneer of new regulatory projects such as combination product, gene therapy, OTC and etc

• Supervise team member for regulatory matters

Qualifications

• University degree in appropriate discipline

• More than 5 years’ experience in a regulatory position in industry

• Must be proficient in both spoken and written English

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. 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 protected veteran, or any other legally protected group status.

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