Job Description

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.

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

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 (Point of Contact) for specific products for country/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 to responds to those asking about location of certain information in the Dossier and forward 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.
• At least 10 years' regional experience in regulatory affairs is required, preferably in pharmaceutical industry.
• Individuals with other credentials and who possess an excellent working knowledge of Regulatory Affairs or Clinical Research gained within industry would be considered.
• 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.
• Able to manage complex problems/projects by exercising independent decision making and analytical thinking skills.
• Ability to assess, prioritize, and complete multiple projects, tasks, and/or responsibilities.
• Outstanding collaborative skills with an ability to work both proactively and reactively in a timely manner in a dynamic fast-paced environment.
• Outstanding, interpersonal, written and oral communication skills.

WHAT YOU CAN EXPECT

• Regional exposure
• Opportunity to work with a market giant

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Who we are...

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

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.

Current Employees apply

Current Contingent Workers apply

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status: Regular

Relocation: No relocation

VISA Sponsorship:

Travel Requirements: 25%

Flexible Work Arrangements:

Shift:

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Hazardous Material(s):

Number of Openings: 1