Job Description

Regulatory Affairs Associate Manager

• Opportunity to be a part of a global Regulatory Affairs - General organization in Malaysia!
• Based in Malaysia, 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 Malaysia for more than 25 years and in AP for over 60 years.

WHAT YOU WILL DO

Primary Responsibilities

• Develop and implement regulatory strategy to accelerate products and indications pipeline
• Drive regulatory policy shaping initiatives with local regulatory agency, trade association and other external stakeholders
• Ensure regulatory support through product life cycle including labelling, CMC and dossier modifications
• Coordinate the preparation of post-approval regulatory documents in accordance with agreed timeframes
• Lead/participate in negotiations during regulatory approval processes for applications with the regulatory agencies
• Participate in inter-company organizations focusing on specific industry-related issues
• Keep abreast on all regulatory requirements (local, ASEAN, ICH, WHO), market, and industry developments
• Build long term effective relationships and keeps open communication with Regional / Global colleagues
• Monitor regulatory agencies and industry changes, trends and requirements to contribute effectively to product development and regulatory strategies
• Cooperate with other departments to collect information needed for recall reporting, including initial and follow-up reports, and others
• Contribute with regulatory support during health authority site inspections
• Attend inter-departmental meetings discussing product issues and priorities to develop clear and concise plans with milestones to reach the desired outcomes
• Participate in development of regulatory strategies for product changes, to ensure compliance with the current regulatory requirements
• Participate in working and industry groups to provide input to shape the regulatory landscape and maintain prospective awareness of evolving regulatory expectations

Education Minimum Requirement:

Preferably registered pharmacist with Malaysia Pharmacy Board or Graduates with Science related degree eg. BioMedical, Biochemistry, Pharmaceutical Science, Biotechnology etc.

Required Experience and Skills:

• A minimum of 5 years of relevant pharmaceutical regulatory experience, preferably with MNC background.
• Ability to communicate well verbally and in writing to internal and external stakeholders is essential.

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.

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: No

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings: 1