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

Education Minimum Requirement:

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

Required Experience and Skills:

• 5-7 years in Regulatory Affairs of Animal Health industries
• Experienced in handling registration of veterinary biological products, dealing with Department of Veterinary Services (DVS).
• Veterinarian or Pharmacist are welcome

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

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Employee Status: Regular

Relocation:

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Flexible Work Arrangements:

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Merck Sharp & Dohme