Senior Specialist Regulatory Affairs

Location: Germany

SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!

THE COMPANY

Our client is a professional Pharmaceutical organization, based in Hessen Germany.

Our client is one of the world‘s leading pharmaceutical companies. For their office in Frankfurt am Main, where the focus is on clinical strategy, regulatory affairs, pharmacovigilance, global quality management and data and document management, we are looking for an expert in Regulatory Affairs.

ROLE DESCRIPTION

Senior Specialist Regulatory Affairs (m/f)

RESPONSIBILITIES

- provide primary contact to Competent Authorities for assigned projects
- ensure that regulatory activities are performed at high quality and compliant to local regulatory requirements
- provide regulatory expertise to development, registration and maintenance of pharmaceutical products within assigned projects
- develop and maintain regulatory strategy, including regulatory intelligence and regulatory risk assessments with focus on European regulatory procedures and requirements
- maintain awareness of and support compliance to European and other local regulatory requirements and update colleagues as appropriate
- provide support to the Head of Regulatory Affairs Region Europe, Global Development Teams, Life Cycle Teams and Brand Teams for decision making processes and provide sound advice to the employees and Senior Management related to regulatory requirements
- Develop and maintain SOPs and WPs in the area of Regulatory Affairs Region Europe responsibilities to ensure compliance with regulatory requirements and guidance documents as assigned
- collaborate with other functional areas (Pharmacovigilance, Clinical Development, medical Affairs, Marketing, Quality Management and Supply Chain) and other partners to ensure that processes are established and adhere to.

REQUIREMENTS

- University degree in medicine, pharmacy, life sciences or chemistry
- Minimum of 8 years relevant experience in regulatory affairs within the pharmaceutical industry
- experience in global regulatory affairs encompassing strategic and operational aspects
- experience in interacting with the WHO is much appreciated
- experience in working in and communicating with cross-functional, multi-cultural project teams
- Team player with strong analytical skills and attention to detail
- computer literate with MS Office and document management systems
- excellent written and oral communication skills in English, German is a plus
- willingness to travel

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Anke Berndzen.