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\xe2\x80\x99s 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

• Act as Poison A (Wholesale) License holder
• 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 as Designated Point of Contact (DPOC) in the coverage region on any communication within the scope of PV and follow the Global PV policies.
• 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:
- Bachelor degree of life sciences, preferably veterinarian and licensed pharmacist
- Min 2-4 years of relevant experience

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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Merck Sharp & Dohme