Regulatory Affairs Manager

Your Mission :

Manage all post marketing regulatory activities of chemical pharmaceutical drug products including renewals, CMC variations, update of Labeling, extension of indications.

Your Responsibilities :

• Maintenance of registration files for all post-approval activities.
• To author, review and lead high quality documents for regulatory submissions.
• Prepare response to questions raised by competent regulatory agencies.
• Provide expert content guidance for quality portions of the CTD, ensuring compliance of documentation to internal company standards and external regulatory guidelines.
• Coordinate with partners’ regional regulatory teams for global strategy.
• Define, develop and lead regulatory strategies for post-marketing activities.
• Assess internal change controls.
• Maintenance and update of the Product Information.
• Internal Regulatory contact for Pharmacovigilance and Marketing and Business.
• Keep up to date Regulatory Information Management System.
• Maintain policy & regulatory intelligence.
• Provide regulatory strategies for projects as RA representative in cross-functional teams.

Your Profile :

• Degree in Science (e.g. Chemistry, Pharmacy) or equivalent.
• Min 3 years’ experience in Pharmaceutical regulatory affairs for sterile parenteral chemical drugs, ideally prolonged-release formulation.
• Maintenance, Renewal, Update Labeling, Extension of indications.
• Good knowledge of ICH Quality standards, European and US pharmacopoeias, International CMC Guidances, including ASEAN.
• Previous experience in meeting with Health agencies.
• Strong attention to details and organizational skills required.
• Good written and oral communication, technical writing and editing skills.
• Ability to handle different topics and willingness to learn.
• Demonstrate good interpersonal skills, ability to work with others in an international team environment, effective interactions in cross department teams.
• Orientation for work result details, with emphasis on accuracy and completeness.
• Fluent in French and English.