Regulatory Affairs Consultant - CTA (German Speaking)

Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability.

This role can be either office or home based in Romania, Poland, Italy, Hungary, Lithuania, Spain, UK, Ireland, Croatia or Switzerland and you will be working in an innovative and collaborative environment connecting with colleagues from around the world. This role will require knowledge in Regulatory Clinical trial applications in Germany and be fluent in German in both verbal and written formats. If you have experience in coordinating Regulatory Clinical trial applications in the EU and other regions APAC, Americas, Africa that would be desirable.

As the Regulatory Consultant you will have an understanding of the organization’s consulting models and methodologies, as well as, good knowledge of what services Parexel provide. You must have strong technical skills and also be able to develop specialist knowledge of a particular subject and/ or market. You will ensure the timely performance of work within a project scope to the quality expectations of the group and the client. When serving as a Project Lead or Work Stream Lead, you will also assure the work of the entire team or work stream is delivered on time and that it meets client’s and PC’s quality expectations.

Key Accountabilities:

Project Execution

- Typically works within a team environment but may work; independently delivering services within their technical area of; expertise;

- Works within broad project guidelines but liaises closely with more; senior colleagues to discuss issues and resolve conflicts

- Demonstrates ability to prioritize work and define steps needed to; achieve specified project outcomes

Consulting Activities and Relationship Management

- Follows and implements the organization’s consulting models and methodologies

- Provides technical and/or business consulting services within

personal area of expertise

- Completes assigned activities within project scope and objectives with an understanding of issues which may impact project profitability

- Collaborates with colleagues and client to identify and resolve technical and process issues

Business Development

- Continue to build a network of industry colleagues through relationships formed during project engagements or through other industry experience

- Communicates potential new business leads to PC management and account managers

- May participate in project scoping calls and/or proposal preparation with the support of senior colleagues

Parexel related responsibilities

- Meets established metrics as specified in scorecard on an annual basis

- Completes basic job-related responsibilities, including timesheets, expense reports, maintenance of CVs, project deliverable archiving, participation in internal initiatives/projects or as a mentor as requested by management.QualificationsEducation:

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

Skills:

- High-level consulting skills

- Critical thinking and problem-solving skills

- Project leadership and management knowledge

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

- Client-focused approach to work

- Results orientation

- Teamwork and collaboration skills

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

- Networking

- Business analysis

- Self-confidence and control

Knowledge and Experience:

- Previous CTA Regulatory Submission experience. acting as Regulatory Lead is desirable.

- Fluent in German in all formats, reading, speaking and writing

- Previous CRO / Pharma, Regulatory agency experience acting in the capacity of a Regulatory Affairs Consultant or Senior Regulatory Affairs Consultant is essential.

- Strong experience in a Regulatory industry-related environment; experience with a regulatory agency (such as FDA, MHRA) is a plus

- Client-focused approach to work (Quality)

- Regulatory Project Management/Lead experience

In return we will be able to offer you a structured career pathway and development within the role including awareness and understanding of the industry. Your hard work will be rewarded with a competitive salary, bonus and benefits package including days holiday and other leading edge benefits that you would expect with a company of this type.

Apply today to begin your Parexel journey!