RA Specialist – MSD – 서울

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.

Obtain the regulatory approval timely through the best registration strategy and maintain product license with local regulation and global compliance standard.

WHAT YOU WILL DO

• Achieve timely registration of new products and their variations/updates
  • Prepare and submit registration dossier in accordance with the plan
  • Communicate effectively with the Agency, HQ and appropriate experts
• Support Regulatory Affairs Manager to develop assigned product specific plans and registration strategies
  • Analyze regulatory and product information
  • Define and anticipate potential issues
• Maintain product licenses
  • Update safety and quality information timely
  • Meet the compliance for global RA database
  • Follow up post-approval activities (re-examination, DMF, annual report, etc.)

WHAT YOU MUST HAVE

To be successful in this role, you will have:

• Functional Knowledge: Drug Development, Pharmaceutical Regulations
• Skills: Cross functional and interpersonal communication/relationship, Fluent written & spoken English
• Leadership Behaviors: Commitment/Self-discipline, Customer/Quality/Compliance focus
• Others: More than 2 years of RA experience, Candidate with experience in QA/Clinical Trials/PV/Medical field can be considered, Pharmacy major is preferred

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:

Regular

Relocation:

Domestic

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R146265