We are currently looking for an experienced Regulatory Affairs Manager with focus on the EurAsian Economic Union and APAC markets to join our team.
You are responsible for the creation and implementation of regulatory strategies based on the good knowledge and appropriate interpretation of guidelines and directives.
Based in Geneva, you report to the Regulatory Affairs TA and International Team Lead and your responsibilities include :
Keep up to date with the latest regulatory requirements with the focus on the regulatory strategy in EurAsian Economic Union and APAC.
Act as Point of Contact between Regulatory Affairs of the partner company, local regulatory representatives of OM Pharma and corporate or regional stakeholders
Maintain the assigned Regulatory Databases according to internal guidelines
Manage the response to Health Authority questions / requests for information
Plan all regulatory activities with the assigned partner companies and ensure timely execution
Ensure compliance of regulatory dossiers with legal requirements in close collaboration with other functions of Regulatory Affairs such as the Therapeutic Groups, Labelling, Reg Ops and CMC
Responsible for ensuring successful dispatch and submission of new marketing authorizations, life cycle management (variation filings, extension applications etc.) in the assigned territory
Drive the approval process.
Support GMP inspections of manufacturing sites by competent authorities (i.e. EAEU, Russia, Belarus, Kazakhstan and China inspections)
Manage product label information development in accordance with the regional requirements
Cooperate with internal stakeholders such as Global Drug Safety, Quality and other departments to ensure compliance and alignment with agreed partner support levels
The successful candidate fulfills the following criteria :
Degree in Life Sciences, Pharmaceutical Sciences or Medical
4 to 6 years of experience in Regulatory Affairs in the EurAsian Economic Union and APAC markets
Good command of French, English and fluency in Russian both in written and oral conversation
Ability to analyze the regulatory requirements (particularly EAEU / APAC regulatory, quality and safety guidelines), perform comprehensive gap assessments and build effective regulatory strategies
Excellent communication and negotiation skills at all levels
Experience with managing EAEU / APAC preparation projects, Russian and Chinese GMP inspections and regulatory activities oversight in CIS / Asian markets
You are a mature regulatory professional, open to new projects and challenges, willing and capable to shape your environment, to setup and to improve work processes, and to influence internal and external stakeholders.
Your excellent project management skills will ensure your success in this role.