Senior Regulatory Affairs Specialist - Contractor

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 and LinkedIn. 

Regulatory Affairs:

• Keep up to date of knowledge on pharmaceutical product registration, variation, line extension and other related laws and regulations.
• Monitor and disseminate information on changes related to the Regulatory Authority: laws and regulations affecting registration, manufacture, distribution, and sale and marketing of AbbVie products.
• Facilitate communication between Area Regulatory lead, local distributor, and the local regulatory authority.

Product Registration and Maintenance:

• Develop registration strategies, prioritize assignments; implement regulatory plan and coordinate multiple projects and activities in accordance with strategic company objectives, annual plan and targets.
• Review, analyze and coordinate data for new products, renewal and variation submissions, and line extensions according to priorities and responses to deficiency letters. Ensure that the content complies with government regulations prior to submission to the Regulatory Authority.
• Maintain an awareness of country’s regulatory legislation and assess its impact on AbbVie’s business.
• Monitor progress of pending applications through the regulatory authority’s system.
• Liaise and negotiate with the local distributor and/or regulatory authority to facilitate and secure expeditious regulatory approvals.
• Manage labeling changes, artwork development and artwork approval of packaging material components.
• Update and maintain regulatory databases.

Support to Marketing Activities:

• Monitor the progress of marketing applications and provide updates on registration status during brand team meetings, as applicable.
• Provide regulatory input and support for marketing plans, product launches and other cross- functional activities.
• Review and provide input and approval on promotional materials, product information and labels for regulatory compliance, as applicable.

• Bachelor’s Degree in Pharmacy or Industrial Pharmacy
• Minimum of 3 years experience in regulatory function dealing with pharmaceutical products. Experience in new drug and/or new biological drug registration will be an added advantage.
• Knowledge of Philippines regulations in pharmaceutical.
• Understands business needs and impact of regulatory issues
• Strong interpersonal skills
• Strong communication skills – both oral and written

All your information will be kept confidential according to EEO guidelines.

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