Regulatory Affairs Manager
Regulatory Affairs Manager
Thailand - Bangkok Apply NowHOW 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 also 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 in Thailand.
Live
What you will do
Responsibilities
STRATEGIC AND EXECUTION
Contributes for the filing plan (MA and Lifecycle maintenance), advising and discussing with the local cross-functional team.
With general supervision, executes 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 owns the country artwork based on source text.
Collaborates with Regional and Global Study Operations (GSO) teams to support local planning and execution 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/advise in the regulatory decision making.
Ensures/supports regulatory product compliance (e.g. IMR, PMCs, pediatric and other agency commitments).
Manages the regulatory submission of urgent safety communications, DHPCs & DILs as required by Amgen SOPs or local regulatory requirements, as needed.
For Local Regulatory Representative (LRR) in Key Markets (KMRLs), the LRR is also responsible for:
Advises Global teams on local regulatory implications and requirements relevant to the global clinical development/Marketing Applications plans and objectives
As part of the Global Regulatory Team (GRT), provides regulatory direction/expertise on local regulatory mechanisms to optimize product development (eg, expediting studies, Orphan Drug Designations, expedited regulatory designations, compassionate use, and pediatric plans)
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 AND 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.
Oversees 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 advises 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
Preferred Qualifications
In-depth regulatory experience in the applicable country(ies).
In-depth knowledge of country(ies) legislation and regulations relating to medicinal products.
Scientific and Technical
Knowledge of Regulatory principles.
Working with policies, procedures, and SOP’s.
Comprehensive understanding of regulatory activities and how they impact 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.
Others
Demonstrate strong teamwork ability.
Good communication skills - both oral and written.
Good negotiation and Influencing skills.
Ability to understand and communicate scientific/clinical information.
Ability to resolve conflicts 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.
Thrive
What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.
Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
Apply now for a career that defies imagination.
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
careers.amgen.com
Equal Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
