Regulatory Submission Technical Advisor

Role – Regulatory Submission Technical Advisor           

Location – Remote or Site based

Rate – Competitive

Type – Perm

Summary:

For one of Planet Pharma’s global CRO clients who possess a growing reputation in not only their retention rates, but also for providing the best training and development in the industry, have an urgent requirement for a Regulatory Submissions Technical Advisor to join on a permanent basis. This role offers great flexibility as can be based either onsite or remotely.   

Responsibilities:

• Provide regulatory submissions strategic advice and guidance to the Regulatory Submissions Manager, the project team, and Sponsor to ensure submissions compliance with appropriate regulations and requirements;
• Prepare and/or review core trial documents for compliance with relevant guidelines/regulations and for trial suitability;
• Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges;
• Independently interact with Sponsors, regulatory agencies and colleagues; and
• Present during bid defenses, general capabilities meetings, and audits, as required.

 Requirements:

• Bachelor’s degree in Life Sciences;
• Significant experience in clinical research;
• Strong understanding of regulatory documentation, guidelines and legislation;
• Ability to review regulatory guidance and develop proactive solutions to regulatory issues and challenges;
• Experience in reviewing and/or writing core regulatory documents; and
• Ability to independently interact with national/regional regulatory agencies.

Apply now for immediate consideration or contact Michael Owusu-Ansah on +44 203 928 6631

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age. Planet Pharma is an Employment Agency providing Global Staffing services.