Regulatory Affairs Officer (4 months)
Servier, a Paris-based international pharmaceutical company governed by the non-profit FIRS (Fondation Internationale de Recherche Servier), has the mission to drive therapeutic progress which will serve patient needs. Operating in nearly 70 countries with drugs available in 140, Servier achieved over €5.9 billion in turnover and €1.320 billion in EBITDA in fiscal 2024.
Employing over 22,000 globally (5,000 in France), the independent company reinvests 20% of its non-generics turnover in R&D. This investment fuels innovation and ensures future sustainability.
Servier's research focuses on Oncology, Neurology (full R&D value chain), and CMVD (Cardio Metabolism & Venous Diseases, development only). With 35+ clinical programs, including 14 new molecular entities, Servier holds a strong position in cardiology (number 6 worldwide) and prioritizes oncology. Key oncology acquisitions include Shire's US oncology activities (2018), Biotech Symphogen (Denmark, 2020), and Agios Pharmaceutical's oncology branch (US, 2021), strengthening Servier's global presence and oncology focus.
Servier Malaysia is now seeking individuals who have strong drive for results, passion for excellence and with high regard for honesty and integrity.
Job Description
This is a fixed-term contract (4 months) position, main duties and responsbilites are:
- To ensure timely submission and approvals of new product registration and registration maintenance (variations, post-marketing surveillance, etc)
- To ensure timely updates of all relevant databases and clear communication with relevant stakeholders.
- To be appointed as Back-up Pharmacovigilance Responsible Person - assist Regulatory Affairs Manager in Pharmacovigilance and Quality related issues for Servier products.
- To assist in reviewing promotional and non-promotional materials.
Candidate Profile
- Degree in Science
- Minimum of 2 years Regulatory and Pharmacovigilance experience preferred
- Excellent verbal and written communication skills
- Fluent in English and Bahasa Malaysia
- Good organizational, problem-solving skills, with attention to detail
- Strong teamwork attitude while able to perform tasks independently
- Possess a high level of integrity, initiative, drive and commitment, with respect for confidentiality.
This position is offered on a fixed-term contract basis for a period of 4 months.
Interested candidates are welcome to apply. The expected contract duration is from end February until end June/ early July.