Hiring company: Merck
Job Description
Regulatory Submission Planner
THE OPPORTUNITY
• 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 across regulatory agencies. We are an international network 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
The Regulatory Submissions Planner will work within the Our Company's Global Regulatory Affairs and Clinical Safety (GRACS) organization, in the Regulatory Affairs Operations – Asia Pacific (RAO-AP) department in Singapore.
The Regulatory Submissions Planner supports the regulatory submission creation and the registration tracking of the company regulatory submission targets from a regulatory operational perspective for the whole of the AP region.
As a member of cross-functional team and for the assigned products, her/she manages all operational aspects from submission planning, document retrieval, to submission creation and delivery to Health Authorities.
This position requires a high level expertise and knowledge of the regulatory landscape across the Asia Pacific region, its registration procedures and a thorough understanding of the technical requirements for dossiers (e.g. eCTD and other submission formats).
Primary Activities include but are not limited to:
• Planning, coordinating and reviewing regulatory submissions with release to Country Operations teams and/or submission to Health Authorities.
• Responsible for developing and maintaining the regulatory submission plan for the assigned projects/products and maintaining the related project milestones.
• Lead Submission Planning Management Teams (SPMT) meetings.
• Work closely with the corresponding Planner based in the HQ (US) on assigned products/projects.
• Drive the submission assembly and delivery process with the Global Submission Publishing team to ensure timely assembly, publishing and archival of assigned products/submissions as per the agreed timelines.
• Responsible for accessing and maintaining the regulatory systems and databases to fulfil daily functions.
• Assist in identifying opportunities to continually improve the efficiency of the submission process and participate in small-scale process improvement projects.
• Maintain knowledge on the regional regulatory procedures (on internal and external guidelines and standards).
WHAT YOU MUST HAVE
To be successful in this role, you will have:
• Bachelors degree in a Life Science related discipline.
• At least 4 years’ experience in the regulatory operations area, regulatory affairs will be an asset.
WHAT YOU CAN EXPECT
• Opportunities across various functional group within biopharmaceutical manufacturing
• Diverse and dynamic team that focuses on development and success.
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., Kenilworth, 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 HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:
RegularRelocation:
Domestic/InternationalVISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
1