Regulatory Affairs Senior Specialist - Trial Transparency Liaison - FSP EMEA

Job Description

Join Us as a Senior Regulatory Affairs Specialist – Make an Impact at the Forefront of Innovation

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As part of our global team, you’ll have the opportunity to serve as a senior contact in providing innovative solutions, including regulatory expertise. As a Senior Regulatory Affairs Specialist, you'll interact with clients to provide strategic regulatory intelligence and guidance supporting product development from preclinical stages through registration and product optimization. You will provide strategic, expedient, and efficient preparation of client deliverables that meet current local, regional, and ICH regulatory and technical requirements. Additionally, you will act as a liaison with internal and external clients in the provision and marketing of these services.

As a trial transparency liaison you’ll be responsible for leading and overseeing the transparency activities on a CTT level: protocol registration, result posting and redaction of CTIS documents and supporting IDT-level transparency activities: anonymization and/or redaction of post-marketing approval documents.

What You’ll Do

Manage and coordinate the global disclosure and transparency (CTT) deliverables in accordance with the company transparency policy:

Initiate and maintain clinical trial registration in various global trial registries (i.e., Clinicaltrials.gov and CTIS).

Lead and coordinate the result posting in various global trial registries.

Manage and coordinate the redactions of the CTIS documents, including the identification of commercially confidential information (CCI).

Maintain an in-depth knowledge of the fast-evolving global transparency and disclosure regulations.

Provide support and/or lead transparency activities as directed.

Assist transparency efforts and operations.

Prepares and reviews regulatory submissions.

Provides regulatory strategy and/or technical advice to internal and external clients, and acts as a liaison in executing strategies.

Leads the development and implementation of project-specific processes for sponsors.

Collaborates extensively with other departments, regulatory consultants, and regulatory authorities.

Assists in identifying and recognizing out of scope activities in a contract in a timely manner and liaises with other departments to follow through on all aspects of contract modifications.

Provides training and guidance to junior team members as appropriate.

Participates in project launch meetings, review meetings and project team meetings.

Supports business development activities, including project budgeting/forecasting.

Education and Experience Requirements

Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).

3+ years of experience in clinical trials, experience in a transparency position (protocol registration, CTIS redaction, clinicaltrials.gov) is a plus.

Experience in and understanding of global clinical trial transparency regulations.

Familiarity with clinical trial documents and knowledge of clinical study and clinical development design.

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.