Job Description

Specialist, Regulatory Affairs

• Opportunity to be a part of a global Regulatory Affairs organization in Malaysia!
• Based in Malaysia, top-ranked biopharmaceutical company on The Straits Times and Statista\xe2\x80\x99s list of Best Employers in Singapore for two consecutive years (2020, 2021).
• Join the premier biopharmaceutical company that has been in Malaysia for more than 25 years and in AP for over 60 years.

\xe2\x80\x8bOur Regulatory Affairs team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver the services and solutions that help everyone to be more productive and enable innovation.WHAT YOU WILL DOPrimary Responsibilities

• The Regulatory Affairs Associate is responsible for ensuring regulatory compliance with relevant regulations and effectively managing timely submissions to the appropriate regulatory authorities.
• Serves as Country Regulatory Affairs (CORA) person.
• Ensures regulatory support throughout product life cycle including labelling and dossier modifications.
• Coordinate the preparation of post-approval regulatory documents in accordance with agreed timeframes.
• Submits supplemental applications and participates in negotiations during regulatory approval processes for applications with the regulatory agencies.
• Participates in inter-company organizations focusing on specific industry-related issues.
• Stays current on all regulatory, market, and industry developments.
• Ensures current knowledge of domestic and some international regulatory requirements.
• Builds long term effective relationships and keeps open communication with Regional / Global colleagues.
• Monitors regulatory agencies and industry changes, trends, and requirements to contribute effectively to product development and regulatory strategies.
• Contributes regulatory support during internal audits and/or health authority site inspections.
• Collaborates in inter-departmental meetings discussing product issues and priorities to develop clear and concise plans with milestones to reach the desired outcomes.
• Participates in development of regulatory filing strategies for product changes, to ensure compliance with the current regulatory requirements.

Education Minimum Requirement:

• Graduates with First class honours or high second upper degree in Pharmacy degree or graduates with Science-related degree e.g., BioMedical, Biochemistry, Pharmaceutical Science, Biotechnology etc.

Required Experience and Skills:Execution Excellence:

• Takes prompt action to accomplish work goals, per compliance standards;
• Takes action to achieve results beyond what is required;
• Be proactive to discuss with manager when encountered with issue or challenges.

Ownership & Accountability

• Takes ownership of the work their does;
• Sets high standards of performance for self and when working with other stakeholders;
• Self-imposing standards of excellence rather than having standards imposed.

Decision Making

• Identifying and understanding problems and opportunities by gathering, analyzing and interpreting quantitative and qualitative information;
• Identifies the best course of action by establishing clear decision criteria, generating and evaluating alternatives and seek alignment with the manager;
• Takes action that is consistent with available facts and constraints and optimizes probable consequences.

\xe2\x80\x8bInnovation

• Proactively confronting difficult issues;
• Willing to offer creative alternatives;
• Maked valiant choices and takes bold action in the face of opposition or fear.

Regulatory Knowledge and Operation experiences

• Have foundational knowledge of Regulatory Affairs work and requirements.
• Knowledge or experiences in managing Medical Devices or Combination Products registration is an added advantage.
• Detail oriented, meticulous, and organized
• Basic IT knowledge
• Able to work within targeted timelines
• Good project management skills
• Self-motivated and strong commitment to achieve desired results and strives for work accuracy
• Team player
• Able to speak up their opinion constructively and respectfully.

WHO WE AREWe 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 FORImagine 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 \xe2\x80\x94 and start making your impact today.Current Employees applyCurrent Contingent Workers applySearch 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: RegularRelocation: No relocationVISA Sponsorship: NoTravel Requirements: 10%Flexible Work Arrangements: HybridShift:Valid Driving License:Hazardous Material(s):Job Posting End Date: 09/8/2024*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

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