Regulatory Affairs Officer - Pharmaceuticals - Support

REGULATORY AFFAIRS OFFICER - PHARMACEUTICALS - SUPPORT

OUR CAMDEN, LONDON BASED CLIENT IS CURRENTLY SEEKING AN EXPERIENCED REGULATORY AFFAIRS SUPPORT ANALYST TO JOIN THEIR TEAM ON AN INITIAL 6 MONTH CONTRACT.

The Regulatory Analyst is a member of Life Sciences Professional Services team; reporting directly to the Regulatory Solutions Consultant. The primary purpose of the Regulatory Support Analyst role is to support the delivery of regulatory professional services globally. This includes working closely with the Regulatory Solutions Consultant and Clinical Solutions Director to ensure that all regulatory projects are delivered to time, cost and quality, all contractual obligations are met and customers have a high level of satisfaction whilst engaging with the client across a project's life cycle.

PROJECT DELIVERY SUPPORT

- Become an integral member of the delivery team within the Life Sciences Professional Services group.
- Act as a point of contact for the customer throughout a project's life cycle.
- Act as the project manager for regulatory professional services to ensure successful delivery of each assigned project; which includes coordination and tracking.
- Escalate any project risks and delivery issues to the Regulatory Solutions Consultant for action and resolution.
- Support and delivers small pilot projects to validate understanding between the proposed solution and customer needs identified during the sales process.
- Support the delivery of non-regulatory professional services as required and agreed with both their direct and Matrix managers.
- Deliver on routine projects and single requests

QUALIFICATION AND EXPERIENCE:

- Ideally a Bachelor's degree in pharmaceuticals or Master's degree in pharmaceutical regulatory affairs
- Knowledge of pharmaceutical regulatory affairs/regulatory intelligence across a given geographic area (eg Europe or North America) mandatory (familiar with drug pipeline, development/approval/marketing, regulatory concepts).
- Customer facing or customer service experience desirable.
- Knowledge of Cortellis for Regulatory Intelligence content and platform (desirable).
- Experience of supporting regulatory professional services or projects (desirable).

KNOWLEDGE AND SKILLS:

- Ability to work with a remote team
- Organized, thorough, aware of own time management and capable to investigate on own initiative and make connections
- Ability to work proactively to tight deadlines whilst maintaining high levels of quality.
- Ability to work effectively within a team and individually as required depending on specific project requirements.
- Ability to interact effectively and gain the respect of customers across the pharmaceutical industry.
- Fluent in English is essential with a second language highly desirable.

CANDIDATES SHOULD SUBMIT THEIR CV IN THE FIRST INSTANCE.