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. 

PRIMARY FUNCTION/OBJECTIVE
Job Summary
•    Responsible for people management for Abbvie Pharma and Allergan Aesthetics portfolio in Singapore. 
•    Responsible for regulatory strategy, submissions and approvals for new product registrations, renewals, variations and maintenance of registered products
•    Provide support to commercial and cross functional teams from regulatory perspective.
•    Represent Regulatory Affairs on Affiliate Management Team
•    Responsible to maintain local SOPs and ensure compliance with regulations 
•    Monitor emerging trends regarding industry regulations to determine potential impact on organizational processes.
•    Responsible for providing input and approval on advertising/promotional materials for regulatory compliance.
•    Hold the pharmacist licence for the company, where applicable.

CORE JOB RESPONSIBILITIES

People Manager
•    Develop and coach team members to meet goals and objectives set. 
•    Lead the team to ensure prioritized objectives that focus on the critical activities are successfully delivered to time and quality
•    Manage the performance and provide guidance to team members supporting the affiliate regulatory activities
•    Develops succession planning for RA team

Product registration and maintenance 
•    Primary contact with Regulatory Authority Department in the country,  maintain and strengthen communication with the appropriate offices.
•    Facilitate communication between Area Regulatory lead and the local regulatory authority.
•    Develop registration strategies, prioritizing assignments; implement regulatory plan and coordinate multiple projects and activities in accordance with strategic company objectives and plan. 
•    Review, analyze and coordinate data for new product submissions, line extensions, and variations, according to priorities and responses to deficiency letters. Ensure that the content comply with government regulations prior to submission to Regulatory Authority.
•    Monitor progress of marketing applications and variations approval process within Regulatory Authority.
•    Liaise and negotiate with  the  relevant  authorities  to  facilitate  and  secure  expeditious regulatory approvals.
•    Manage development projects, including early pipeline products, from RA perspective, with guidance from RA manager, where required.

Business Support
•    Work cross-functionally as required to meet business needs. 
•    Monitor the progress of marketing applications and provide management with a monthly registration status in S&OP meeting and 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 from regulatory perspective. 
•    Participate in business meetings, where applicable
•    Support commercial QA by providing regulatory input where applicable.

Processes
•    Responsible for requests of documents via Abbvie systems.
•    Responsible for artwork and label management.
•    Maintain global Abbvie systems and databases to ensure that all relevant regulatory information is updated.
•    Ensure proper filing and maintenance of local documentation as per corporate procedures.
•    Lead or participate in projects to streamline RA processes to increase productivity

Compliance, SOPs and policies
•    Maintain good knowledge of relevant regulatory corporate policies and ensure compliance.
•    Prepare and maintain local SOPs and policies relevant to Regulatory Affairs to comply with AbbVie global SOPs & policies and Regulatory Authority Department requirements.
•    Ensure adherence to Abbvie SOPs and compliance with regulations. 

Regulatory Intelligence
•    Keep up to date for product registration, variation, line extension and other related law & regulations knowledge.
•    Monitor and disseminate information on changes related to the regulations affecting registration, manufacture, distribution and sale & marketing of AbbVie products, and assess its impact on AbbVie’s business.
 

•    Bachelor’s Degree in Pharmacy or Pharmaceutical Science, and preferably a licensed pharmacist in Singapore
•    Minimum of 5-7 years of regulatory experience in the pharmaceutical industry and/or medical device industry.
•    In-depth knowledge of Singapore regulations in pharmaceutical and/or medical device. 
•    Understands business needs and impact of regulatory issues
•    Excellent oral and written communications skills, with fluent in English. Proficiency in communicating strategic and tactical issues to management.
•    Strong management skills
•    Strong interpersonal skills and negotiation skills, with the ability to influence others without formal authority. Ability to function as an effective leader and team member. 
•    Sound analytical, conceptual, and strategic thinking skills. Ability to work independently, analyze complex problems, and proactively take initiatives. 
•    Demonstrated ability to consistently deliver against time-sensitive deadlines in the midst of conflicting demands. Ability to prioritize and multitask.
•    Commitment to achieve excellence with a strong work ethic and results orientation. 
 

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