Director Regulatory Affairs
Director Regulatory Affairs
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Job Description
PRIMARY FUNCTION/OBJECTIVE
Responsible for people management of the Abbvie Regulatory Affairs team in Taiwan.
Responsible for regulatory strategy submissions and approvals for Pharma and Allergan Aesthetics new
product registrations (pharmaceutical and medical device) renewals variations and maintenance of
registered products in Taiwan.
Responsible for regulatory strategy submissions and approvals for Allergan Aesthetics new product
registrations (pharmaceutical and medical device) renewals variations and maintenance of registered
products in Hong Kong.
Support business and cross functional teams from a regulatory perspective.
Represent Regulatory Affairs on Affiliate Management Team
Responsible for maintaining 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 from regulatory
compliance.
Hold the pharmacist licence for the company where applicable.
CORE JOB RESPONSIBILITIES
People Manager
Provide regulatory strategic direction to Abbvie Taiwan Regulatory Affairs team
Build a highly effective regulatory team; develop and coach team members to meet regulatory goals
and objectives set and to meet business goals
Lead the team to ensure prioritized objectives that focus on the critical activities are successfully delivered on time and with highest quality
Manage the performance and provide guidance to team members supporting the affiliate regulatory
activities
Develop succession planning for regulatory affairs team
Product Registration
Develop registration strategies prioritize assignments; implement regulatory plan and coordinate
multiple projects and activities in accordance with strategic company objectives and plan.
Plan and execute regulatory submissions for new products new indications renewals and required
changes to maintain current registration of all products in alignment with planned timelines
Review regulatory documentation and identify/remediate potential gaps.
Liaise and negotiate with the relevant authorities to facilitate and secure expeditious regulatory
approvals with optimal label.
Liaise with regulatory authorities and trade associations to ensure efficient registration process.
Manage development projects including early pipeline products from regulatory perspective. Drive
regulatory needs in development/pipeline projects.
Business Support
Provide regulatory support to crossfunctional team (medical commercial market access supply
chain and others) as required to meet business needs and to ensure products comply with all applicable laws and regulations.
Provide regulatory input and support for marketing plans product launches and other cross functional activities.
Manage compliance of promotional materials from regulatory perspective.
Support local business teams in tenders hospital listings and any other activities from regulatory
perspective where required.
Provide regulatory updates on registration status in commercial database/report during S&OP
and/or brand team meetings where applicable.
Provide regulatory leadership as needed in product inlicense/due diligence review where applicable
Participate in business meetings where applicable
Support commercial QA by providing regulatory input where applicable
Processes
Develop & implement local processes/system to support regulatory submissions and approvals in
the most efficient manner for drug registrations in accordance with global/regional processes.
Lead and/or participate in global/regional/local projects to streamline regulatory processes to
increase productivity.
Support team in artwork and label management and request of documents via Abbvie systems.
Support team to maintain global and regional systems and databases to ensure that all relevant regulatory information is updated
Support team to ensure proper filing of and maintenance of local documentation as per corporate procedures.
Compliance SOPs and Policies
Ensure adherence to Abbvie SOPs and compliance with regulations.
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 requirements.
Liaise and communicate with global and regional regulatory teams to ensure local processes are
aligned with global policies and relevant regulatory requirements
Regulatory Intelligence
Lobby and influence a positive change of regulatory environment and the formulation of regulations
Keep up to date for product registration variation line extension and other related law & regulations
knowledge.
Monitor changes related to the regulations affecting registration manufacture distribution and sale
& marketing of AbbVie products and assess its impact on Abbvies business.
Communicate changes in a timely manner to relevant stakeholders and management.
Conduct regulatory risk assessments and mitigation plans.
Qualifications :
PREFERRED QUALIFICATIONS
University degree in Pharmacy Pharmacology Biology or related disciplines.
Minimum 15 years regulatory experience in pharmaceutical industry and/or medical device industry.
Indepth knowledge of Taiwan Regulatory in new drug applications for NCE and clinical drug
development. Medical device and clinical trial applications knowledge will be an added advantage.
At least 5 years of people management experience.
Excellent oral and written communication 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 timesensitive deadlines in the midst of conflicting
demands. Ability to prioritize and multitask.
Commitment to achieve excellence with a strong work ethic and results orientation.
Ability to interact effectively at all levels with sensitivity to cultural diversity.
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 AbbVies 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.
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Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
