Associate Director, Regulatory Liaison Asia Pacific
• Opportunity to be a part of our Regulatory Affairs organization!
• Based in Singapore, the regional hub for Asia Pacific (AP) and top-ranked biopharmaceutical company on The Straits Times and Statista’s list of Best Employers in Singapore for two consecutive years (2020, 2021).
• Join the premier biopharmaceutical company that has been in Singapore for more than 25 years and in AP for over 60 years.
WHAT YOU WILL DO
Responsibilities include, but are not limited to:
The Regulatory Liaison role is a broad role encompassing all aspects of regulatory strategy to support countries in region, including clinical, CMC and risk management requirements, and oversight of strategic regional labelling issues. In this role, the Regulatory Liaison has responsibilities including:
- Serves as single POC for specific products for country and HQ.
- Provides regionally focused strategic input to product development across region and across portfolio.
- Contributes to region specific aspects of a development strategy.
- Leads identification of regional specific elements of submissions.
- Owns and leads the overall regional product regulatory strategy, including the corporation and maintenance of regulatory requirements for health authority registration approval.
- Monitors and communicates key strategic issues related to program progress and issues to/from countries and HQ.
- Helps ensure HA deficiency letters are appropriately addressed in a timely manner, by providing specific input from the regional perspective.
- Triages questions and responds to those asking about location of certain information in the dossier and forwards those to HQ which require subject matter expertise.
- Ensures alignment of strategy and priorities for portfolio of products with stakeholders
- Contributes to development and execution of regional regulatory policy issues.
WHAT YOU MUST HAVE
To be successful in this role, you will have:
· Bachelor graduate degree in pharmacy, biological science, chemistry, or related discipline required with at least 10 years’ experience in regulatory affairs is required.
· Individuals with other credentials and who possess an excellent working knowledge of Regulatory Affairs or Clinical Research gained within industry would be considered.
· Outstanding, interpersonal, written and oral communication skills; outstanding collaborative skills with an ability to work both proactively and reactively in a timely manner in a dynamic fast-paced environment
· Ability to assess, prioritize, and complete multiple projects, tasks, and/or responsibilities;
· Able to manage complex problems/projects by exercising independent decision making and analytical thinking skills
· Knowledge/experience of regulations, registration guidelines and regulatory processes for NCEs and product life cycle maintenance in general and preferably in the intended region
· Ability to work independently to achieve results; ability to work in cross-functional and international environment; detail- and goal-oriented, quality conscientious, and customer-focused;
· Ability to adhere to strict project timelines; strong team player; good judgment and problem solving skills, with ability to identify, analyse, and resolve problems in a timely manner
· Fluent written and spoken English is required.
What we look for…
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us — and start making your impact today.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
