Regulatory Affairs Manager, Malaysia

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

•    Responsible for regulatory strategy, submissions and approvals for new product registrations, renewals, variations, and maintenance of registered products
•    Responsible to maintain local SOPs and ensure compliance with regulations are met.
•    Represent Regulatory Affairs on brand teams and cross-functional teams’ meetings. 
•    Responsible for providing input and approval on advertising/promotional materials for regulatory compliance.
•    Provide support to commercial team from regulatory perspectives.
•    Poison License Holder, company pharmacist.

CORE JOB RESPONSIBILITIES

Regulatory:
•    Primary contact with Regulatory Authority Department in the country: To maintain and strengthen communication with the appropriate offices.
•    Supporting Brunei distributor relationship with Brunei regulatory authority
•    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 Regulatory Authority Department: law & regulations affecting registration, manufacture, distribution, and sale & marketing of AbbVie products.
•    Facilitate communication between Area Regulatory leads and the local regulatory authorities.

Product registration and approval:
•    Develop registration strategies, prioritizing assignments; implement regulatory plan and coordinate multiple projects and activities in accordance with strategic company objectives, annual plan and LRP targets.
•    Review, analyze and coordinate data for new product submissions, line extensions according to priorities and responses to deficiency letters. 
•    Ensure that the content complies with government regulations prior to submission to Regulatory Authority.
•    Maintain an awareness of country’s regulatory legislation and assess its impact on AbbVie’s business.
•    Monitor progress of marketing applications through the regulatory system.
•    Liaise and negotiate with the relevant authorities to facilitate and secure expeditious regulatory approvals.

Product maintenance:
•    Ensure up-to-date product registration, variation, line extension and other related law & regulations knowledge.
•    Review, analyze and co-ordinate data for variations submission to marketed products according to priorities and responses to deficiency letters.
•    Monitor progress of variations approval process within Regulatory Authority.
•    Liaise and negotiate with the relevant authorities to facilitate and secure expeditious regulatory approvals.

Local SOPs and policies:
•    Support to prepare and maintain local SOPs and policies relevant to Regulatory Affairs to comply with AbbVie global SOPs & policies and Regulatory Authority department requirements.

Support marketing activities:
•    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, product information and labels for regulatory compliance.

Medical, Pharmacovigilance (PV) and Quality Assurance (QA) Support:
•    Guide and assist medical, PV or QA in regulatory requirements for respective countries.
 

• Bachelor’s degree in pharmacy and preferably a licensed pharmacist in Malaysia
• 7-10 years’ hands on experience in regulatory function in a pharmaceutical industry
• Understands business needs and impact of regulatory issues.
• Wide experience in regulatory documentation required to support regulatory submissions for various product categories in respective countries.
• Well versed in local regulatory requirements with proven track record of successful regulatory approvals.
• Strong management skills
• Strong interpersonal skills, enthusiastic and a team player with positive attitude
• Strong communication skills – both oral and written
• Able to work independently and proactively.

AbbVie 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.