Job Description

Regulatory Affairs Manager - Animal Health

• Opportunity to be a part of a global Regulatory Affairs \xe2\x80\x93 General 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.

Primary Responsibilities

Regulatory

• Product registration
• Plan, manage and oversee RA activities within the coverage region
• 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 RA team 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
• Interact with and present to national regulatory authorities on regulatory related new product submissions strategies and maintenance of current product portfolio, as applicable
• Manage positive networking relationship with national regulatory authorities as necessary
• Provide regulatory review of variation proposals, labeling and additional submission documents
• Assess regulatory of product variations on product lifecycle and communicate as necessary to line-management and cross functional teams
• Collaborate with global regulatory affairs functions to develop global regulatory submission and approval strategies
• Provide correspondence to national regulatory authority enquiry(s) for products responsible
• Provide regulatory advice and guidance to line-management and cross functional teams to ensure product submissions and importations meet regulatory requirements
• Review and verify packaging labels where applicable, revise labels by using PDF program per local regulatory authority requirement for registration and importation
• Develop SOPs and provide regulatory input to product life-cycle planning
• 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.
• Oversee and develop a team of highly motivated, experienced and dedicated direct reports

Pharmacovigilance (PV)

• Responsible as DPOC in the coverage region on any communication within the scope of PV
• Responsible for AE/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 our company\xe2\x80\x99s policies and local requirements.
• Involve in creating and maintaining local procedures that aligns local processes with GPV procedures.
• Responsible for monitoring new or existing local PV legislation and regulations and ensuring timely implementation of new regulations and communicating to GPV.
• Oversight contractual agreement to ensure that PV template is indicated, and PV activities are performed in accordance with requirement
• Involved in PAS to ensure that PAS are performed in accordance with company requirement and AEs from PAS are reported.
• Responsible for the review of local literature review as per GPV and local procedures.
• Prepare for audits or inspections for Indonesia and participate in audits or inspections
• Conducts mock product recall procedure as necessary according to global quality and local procedures
• Ensure that assigned PV training is completed within timeline.

Education Minimum Requirement:

• Graduates with Science related degree eg. Veterinary science / Animal science BioMedical, Biochemistry, Pharmaceutical Science, Biotechnology etc.

Required Experience and Skills:

• Experienced RA in local or multinational Animal Health companies
• Experienced in handling registration of veterinary biological products, dealing with Department of Veterinary Services (DVS).
• Veterinarian or Pharmacist are welcome

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 \xe2\x80\x94 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\xe2\x80\x99s 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.

Employee Status: Regular

Relocation: No relocation

VISA Sponsorship:

Travel Requirements: 10%

Flexible Work Arrangements: Hybrid

Shift: Not Indicated

Valid Driving License:

Hazardous Material(s):

Merck Sharp & Dohme