Regulatory Affairs Manager

On behalf of our client, one of the world's 20 leading pharmaceutical companies, we are looking for a successful candidate to fill the Regulatory Affairs Manager position.

KEY RESPONSIBILITIES:

• Regulatory Strategy and Registration Activities
• Ensure new Regulatory Intelligence is captured via an Impact Assessment 
• Manage cross-functional interactions and Pre-submission review and negotiate with HA
• Ensure timely dossier tailoring, dispatch, and submission
• Maintain Mas
• Archiving of local Regulatory submission documents
• Adhere to a Company's internal compliance rules
• Contribute to the QM Quality Plan
• Contribute to the CAPA process as appropriate
• Participation in Promotional Material/ Clinical label Approval Process 
• External Relationships and Engagement
• Training and Development Management
• Support for Local and Global Projects: provide timely input to GRA on cross-functional issues impacting RA in alignment with regional RA Head.
• Involvement in Business Platforms: active participation and contribution to different business forums 
• Member of Brand teams, local Launch teams, Partner of PV, etc. 
• Support launch activities
• Other regular Regulatory Affairs Manager position job duties.

REQUIRED QUALIFICATION & BACKGROUND:

• Pharmaceutical or medical degree, Life-Science degree is acceptable
• At least 2 years experience in a Regulatory Affairs Manager position in an innovative global or middle-sized European pharmaceutical company
• Upper-intermediate English is a must.
• Positive attitude, optimism, open communication, desire to grow professionally

COMPANY OFFERS:

• Competitive remuneration and a corporate bonus scheme
• Medical Insurance
• Corporate car and other needed tools for comfortable work
• Professional development and opportunity to realize your potential in a flexible, friendly global working environment.