Senior RA Specialist

Location Leiden
Discipline: Biotechnology, Pharmaceutical, Medical Device
Job type: Temporary/Freelance
Contact name: Selin Ozbeden

Contact email: s.ozbeden@panda-int.com
Job ref: 12300
Published: 23 days ago

For this booming pharmaceutical client, I am urgently looking for a Regulatory Affairs  professional who has minimum of 5 years of medical device and/or medicines regulatory affairs experience required in an International Company.

RESPONSIBILITIES

• Pre-regulatory authorization;
• Management of specific regulatory requirements regarding Medical Devices and Drug distribution;
• Identifying rapidly regulatory issues concerning MD, report them to Management and Franchise, investigate and suggest solutions to resolve them;
• Oversight and management of company license or registration for MDs, Human Tissue products and Drugs.
• Review and approval of promotional materials (Copy review for Medical Devices and Drugs);
• Review and approval of labelling of MDs and Drugs in local language;
• Provide regulatory support (in collaboration with franchises and EMEA/US Regulatory Affairs) to marketing, sales representatives, Customer Service (especially for tenders)
• Review and update of processes and procedures linked to all relevant Regulatory Affairs activities
• Liaison with local Competent Authorities
• Ensure applicable company compliance with all relevant country and regional requirements, company regulations, policies and procedures
• Ensure all post marketing regulatory requirements are met, with an emphasis on ensuring all external communication/marketing materials are compliant with Region guidelines and restrictions.

 

PROFILE
• Required education: Bachelor's / Master Degree.
• Advanced degrees and education in pharmacy, medicine, engineering, or science.
• A minimum of 5 years of medical device and/or medicines regulatory affairs experience required in an International Company.
• Languages: English, Dutch, notion in French language will be appreciated.
• Profound knowledge of regulatory requirements for Medical Devices and Drugs;

• Ability to persuasive communicate and influence regulators and other key stakeholders;
• Highly skilled in establishing partnerships and collaboration with business partners, Franchise RA and regional RA, as well as other stakeholders;
• Strong results-orientation and sense of urgency;
• Solid capacity to analyze, interpret and synthesize on regulation and guidelines;
• Strong capability of self-awareness and adaptability.

 

START DATE

  • 1st of June

DURATION

  • 2+ years

INTERESTED?

If you’re interested in the above description, please apply with your CV and a letter of motivation by clicking on the ‘apply’ button below. For further information, please contact Selin Ozbeden at  +31 (0)20 20 44 502 or by email at s.ozbeden@panda-int.com