Senior Regulatory Affairs Consultant

We are recruiting for experienced Regulatory Affairs Consultant in France to work on CTA Submissions under EU CTR.

Key Deliverables in the role:

• Manage the local submissions (as Local Regulatory Contact - LRC) but should also be able to coordinate the regulatory submissions in all participating countries as Regulatory Lead.

• Regulatory submission of Clinical Trial in Belgium and France according to EU-CT directive but also via EU-CTR process (experience in this field would be appreciated).

• Regulatory submission of Compassionate Use Program and Observational studies in Belgium and France according to local legislation.

• You will be responsible for the labelling of the health products used in those studies, with creation of the master label, review of the regulatory requirements for Belgium and France and translation / review of the translation for all French speaking countries.

• ​​​Participate in Regulatory Operations meetings, project team meetings, and maintain relationships with other departments, clients, and regulatory agencies as necessary.

You will need:

• Educated to at least Bachelor of Science level or Bachelor of Science

• Relevant clinical research experience in regulatory affairs and management of international clinical trials

• Fluent in written and spoken English as well as local language

• Extensive prioritization skills; must be able to resolve conflicting priorities to meet tight deadlines while maintaining quality and attention to details

• Ability to work with a multinational team, focusing on multiple issues under tight timelines

• Creative problem-solving skills, which supports client-focused approach to work

• Experience in clinical study start-up

Benefits of working at ParexelOur success depends on the knowledge and capabilities of our teams here at Parexel. We are committed to developing our employees in a continuous learning environment - one where we challenge you with engaging work and where every experience adds to your career development.We can reward you with work/life balance and a comprehensive and competitive total reward package that comprises, competitive base salary, combined with recognition programs, employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career.We encourage you to apply now!