Regulatory Affairs Consultant - 2 Year Contract

We are recruiting for a Regulatory Affairs Consultant to join our Clinical Trial Regulatory Services EU Consulting team in Poland .This is an ideal role for a Regulatory Leader who would excel working in a fast-paced international team. This is a 2 year contract initially.

German language skills are highly desirable but not essential for this role.

You will be responsible for:

- Acting as a local regulatory Lead for clinical trials in Poland and other european countries, you will be responsible for preparation and quality control of local regulatory submission packages for submissions to RAs to ensure regulatory compliance, accuracy and completeness.

- Acting as a regulatory lead managing the regulatory submission strategy and process worldwide throughout entire project life cycle, ensures global regulatory compliance and cross-functional communication.

- Providing regulatory consultancy and support for establishing the submission strategy for clinical trial application, response management, amendments and other maintenance submissions. Interacting with regulatory authorities, as required; liaise with internal and external partners on assigned projects.

- Preparation, review and approval of labels.

- Mentoring junior/new colleagues. QualificationsSkills:

• Regulatory Project management knowledge

• Excellent interpersonal and intercultural communication skills, both written and verbal

• Client-focused approach to work (Quality)

• Results orientation

• Teamwork and collaboration skills

• Consulting skills

• Critical thinking and problem-solving skills

• Proficiency in local language and extensive working knowledge of the English language

Knowledge and Experience:

• Several years of experience in an industry-related environment

Education:

• Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred