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.
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