Regulatory Affairs Manager

Oxygen Consultancy

We are looking for a “Regulatory Affairs Manager” for one of the leading companies in pharmaceuticals industry.

Qualifications:

• University degree in related departments
• Minimum 7-8 years of Regulatory Affairs experience in industry
• Minimum 2 years of team management experience
• Preferably experience in Middle East (ME), CIS, US &EU countries regulations
• Fluency in English, both oral and written communications
• Expert knowledge of national legislation and regulations relating to medicinal products
• Computer skills (MS Office programs)
• Building relationships with regulatory authorities
• Defining and implementing policies, procedures and SOP’s
• Advanced negotiation, collaboration, persuasion, communication and relationship building skills
• Team Leadership skills
• Strong analytical mind and problem solving skills
• Result oriented and proactive
• Multi-task oriented and ability to work with cross-functional teams

İŞ TANIMI

Job Description:

• Managing whole Regulatory process including Technical, Operational and Artwork processes
• Developing, implementing and maintaining processes and policies to meet Regulatory components of legislation and company needs
• Obtaining and maintaining product licenses
• Being the primary point of contact for regulatory authorities in company
• Give Regulatory expertise to all projects which need to follow regulations
• Preparing Regulatory Affairs plans, budget and timetables
• Ensuring the necessary documentation and supporting local audits