Job Information
Amgen Regulatory Affairs Manager in Hong Kong, Hong Kong
Regulatory Affairs Manager, Hong Kong
Hong Kong
HOW MIGHT YOU DEFY IMAGINATION?
Amgen is one of the world’s leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring a Regulatory Affairs Manager, Hong Kong
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What will you do
The Local Regulatory Representative (Manager) is assigned to one or more Amgen products, and plans and drives the Regulatory strategies for that product(s) in their country(ies). The product(s) assigned have medium complexity programs/strategies and medium impact to Amgen.
Assist in aligning local regulatory requirements with Amgen’s corporate standards.
Provide local input to and implement regulatory strategies.
Plan and lead local regulatory submissions in compliance with corporate standards and local regulatory requirements.
Provide guidance on local mechanisms to optimize product development and regulatory approvals
Ensure local labels are developed and maintained in line with local legislation and Amgen standards and procedures.
Ensure and support local regulatory product compliance (eg, IMR, PMCs, and agency commitments)
Act as the point of contact with regulatory agencies.
Strategy & Delivery
Contributes for the filing plan (MA and Lifecycle maintenance), advising and discussing with the local cross-functional team.
With general supervision, delivers the filing plan (MA and Lifecycle maintenance) for their country(ies), where applicable.
Ensures regulatory submissions are made on time and meet Amgen’s corporate and local regulatory requirements.
Creates, reviews, and approves source text for country labeling, and is responsible for the country artwork based on source text.
Collaborates with Regional and Global Study Operations (GSO) teams to support local planning and delivers for clinical studies in accordance with national legal and regulatory requirements (where appropriate).
Reviews and approves the promotional and non-promotional materials.
Monitors changes in the local Trade Associations/national legislation and forwards information to local/regional groups communicating the impact to Amgen.
Monitors the external regulatory environment to help inform/guide in the regulatory decision making.
Ensures/supports regulatory product compliance (e.g. IMR, PMCs, pediatric and other agency commitments).
Leads the regulatory submission of urgent safety communications, DHCPs & DILs as required by Amgen SOPs or local regulatory requirements, as needed.
Health Authority Interactions
Acts as the point of contact with regulatory agencies in fulfilling local obligations.
Participates/contributes to local agency interactions and their preparation.
Communication & Collaboration
Works closely with cross-functional colleagues in the country, Affiliate or Hub to align on strategy and deliver country/Affiliate/Hub goals.
Exchanges regulatory information and intelligence with other regulatory colleagues and cross functional teams on an ongoing basis and provides advice on local regulatory considerations/regulations in a timely manner.
Partners with International Regulatory Leads (IRLs) and Global Regulatory Leads (GRLs) to support the regulatory development, registration, and lifecycle management of all Amgen molecules.
Partners with peers to ensure consistency on procedures.
Acts as contact and create relationships with Agency staff on specific product assignment (if applicable).
Establishes regular contacts and interactions with Distributors (if applicable).
Provide SME support to process improvement projects / initiatives.
Country Specific Activities
Assists locally in Healthcare Compliance activities where applicable.
Participates in local regulatory process improvements, initiatives and training.
Leads all aspects of external vendor/contractor relationships where applicable.
Assists locally in Healthcare Compliance, QA or pharmacovigilance activities where applicable.
Regulatory Research
Maintains an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to Amgen products
Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement
Mentoring
- Mentors and/or guides other(s) Local Regulatory Representatives at more junior levels.
Win
What we expect of you
Basic Qualifications
Doctorate or Master’s degree (scientific area) and 3 years of directly related experience OR
Bachelor’s degree (scientific area) and 5 years of directly related experience
Knowledge of Regulatory principles.
Working with policies, procedures, and SOP’s.
Comprehensive understanding of regulatory activities and how they have an effect on other projects and/or processes.
General knowledge of national legislation and regulations relating to medicinal products.
General awareness of the registration procedures/challenges in the country(ies) for CTAs, MAs and all lifecycle management activities.
Knowledge and experience in the country(ies) regulatory environment relevant for product area and development stage.
Understanding of drug development.
Preferred Qualifications
In-depth regulatory experience in the applicable country(ies).
In-depth knowledge of country(ies) legislation and regulations relating to medicinal products.
Demonstrate strong collaboration.
Good communication skills - both oral and written.
Good negotiation and Influencing skills.
Ability to understand and communicate scientific/clinical information.
Ability to resolve disputes and develop a course of action leading to a beneficial outcome.
Cultural awareness and sensitivity to achieve results across both regional, country and International borders.