Regulatory Affairs Specialist

Job Description

Specialist, Regulatory Affairs

• Based in Malaysia, named one of the Best Companies to Work for in 2019 by HR Asia
• Join the premier biopharmaceutical company that has been in the business for more than 25 years and in AP for over 60 years.

Overall Purpose

Responsible for ensuring that regulatory strategies and regulatory activities are effectively executed in compliance with national legal requirements to meet business objectives.

WHAT YOU WILL DO

Regulatory

• Product registration
• Manage and oversee all product’s regulatory lifecycle process; submission; approval and maintenance activities (variation, renewal) in relation to the following national regulatory authorities as follows:

Malaysia

- Department of Veterinary Services (DVS) Putrajaya, Sabah & Sarawak, MoA
- National Pharmaceutical Regulatory Agency (NPRA), MoH
- Pharmaceutical Services Division (BPF), MoH
- Pesticides Board, MoA

Singapore

- Animal & Veterinary Services (AVS) / National Parks Board (NPARKS), MoA

Brunei

- Division of Livestock and Veterinary Service, MoA
- Department of Fisheries, MoA

• Assess registration feasibility and acceptability of products for importation
• Registration timeline setting and communication to the RA team leader as well as local and global cross-functional units
• Identify data needed, prepare and/or obtain data and review to ensure that they are effectively presented for the registration of product
• Manage positive networking relationship with national regulatory authorities as necessary
• Provide regulatory review of variation proposals, labeling and additional submission documents
• Provide correspondence to national regulatory authority enquiry(s) for products responsible
• Review and verify packaging labels where applicable, revise labels by using PDF program per local regulatory authority requirement for registration and importation
• Manage secondary repackaging procedures in line with SOPs and regulatory requirements
• Maintain up-to-date legal and regulatory knowledge on the registration, import and sale of products.

Pharmacovigilance (PV)

• Responsible for Adverse Event (AE) and Product Quality Complaint (PQC) reports management, including case intake and follow up request/activities
• Responsible for record retention and archiving of all safety related data and documents in accordance with company policies and local requirements.

WHAT YOU MUST HAVE

To be successful in this role, you will have:

• Graduates with Science related degree eg. Veterinary science / Animal science BioMedical, Biochemistry, Pharmaceutical Science, Biotechnology etc.
• Experienced in handling registration of veterinary biological products, dealing with Department of Veterinary Services (DVS).
• Registered Veterinarian

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.

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