✨ AI Summary
The Senior Regulatory Affairs Specialist will manage regulatory activities to ensure pharmaceutical products comply with regulations, guidelines, and company standards throughout their lifecycle. Key responsibilities include reviewing documents, preparing regulatory documentation, ensuring compliance with requirements, monitoring regulatory changes, analyzing regulatory information, coordinating with cross-functional teams, supporting regulatory submissions, and maintaining accurate records. The role requires a Bachelor's degree in a related field, 4-7 years of experience in pharmaceutical Regulatory Affairs, strong knowledge of regulations, professional English, computer proficiency (MS Word, Excel), French language skills, analytical, problem-solving, organizational, time management, communication, interpersonal, and attention to detail skills.
Requirements
Bachelor's degree in pharmacy, Pharmaceutical Sciences, Science, or a related field. 4–7 years of relevant experience in Regulatory Affairs within the pharmaceutical industry. Strong knowledge of pharmaceutical regulations and regulatory guidelines. Professional English level is mandatory, with strong reading and writing skills to be assessed during screening. Strong computer skills, particularly MS Word and Excel. French language proficiency. Strong analytical and problem-solving skills. Excellent organizational and time management skills. Strong communication and interpersonal skills with the ability to work effectively across teams. High attention to detail and ability to manage multiple priorities.
Description
Job DescriptionSenior Regulatory Affairs SpecialistJob Purpose:Manage regulatory activities to ensure compliance of pharmaceutical products with applicable regulations, guidelines, and company standards throughout the product lifecycle.Key Responsibilities:Review and assess scientific and legal documents to ensure regulatory compliance.Prepare, organize, and maintain regulatory documentation and information.Ensure compliance with applicable regulatory requirements and industry guidelines.Maintain thorough knowledge of the company's product portfolio and related regulatory requirements.Monitor changes in regulatory legislation and guidelines and assess their impact on products.Analyze regulatory information and provide appropriate recommendations.Coordinate with cross-functional teams to ensure timely completion of regulatory activities.Support regulatory submissions, responses, renewals, variations, and other product lifecycle activities.Maintain accurate regulatory records and ensure timely follow-up on regulatory commitments.Requirements:Bachelor's degree in pharmacy, Pharmaceutical Sciences, Science, or a related field.4–7 years of relevant experience in Regulatory Affairs within the pharmaceutical industry.Strong knowledge of pharmaceutical regulations and regulatory guidelines.Professional English level is mandatory, with strong reading and writing skills to be assessed during screening.Strong computer skills, particularly MS Word and Excel.French language proficiency.Strong analytical and problem-solving skills.Excellent organizational and time management skills.Strong communication and interpersonal skills with the ability to work effectively across teams.High attention to detail and ability to manage multiple priorities.