Regulatory Affairs Professional - CTA

Parexel International Corporation; King of Prussia (Montgomery County); Remote; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking experienced Regulatory Affairs Professionals to manage clinical trial submissions. This role offers the opportunity to work on local, regional, and global projects, ensuring compliance with EU regulations. Ideal candidates will have a strong background in regulatory affairs, be able to prioritize effectively, and possess creative problem-solving abilities. Join a dynamic team where your contributions will support innovative clinical research initiatives, and enjoy the flexibility of remote work while collaborating with a multinational team. This is a fantastic chance to advance your career in a meaningful way.

Qualifications

• Experience in regulatory affairs and management of international clinical trials.
• Fluent in written and spoken English.

Responsibilities

• Manage local submissions as Local Regulatory Contact and coordinate submissions as Regulatory Lead.
• Participate in Regulatory Operations meetings and maintain relationships with clients and regulatory agencies.

Skills

Regulatory Affairs

Clinical Trial Submissions

EU-CTR Knowledge

Prioritization Skills

Problem-Solving Skills

Multinational Team Collaboration

Education

Bachelor of Science

Job description

We are recruiting for experienced Regulatory Affairs Professionals on various levels. In this role, you will focus on clinical trial submissions. We are looking for someone who is experienced in CTA, EU-CTR knowledge and experience would be a strong plus. The role can be based in our office in Madrid or remote.

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 Spain according to EU-CT directive but also via EU-CTR process (experience in this field would be appreciated).

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

• You may be involved in local, regional, and/or global projects

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

• 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

• Fluent in written and spoken English