E stablished in 2005, DLRC Ltd has developed a deserved reputation for being a leading consultancy, with a wealth of regulatory and scientific knowledge and considerable experience in both leadership and management. The company has recently expanded to include affiliates based in Germany and the US.
Our growing team comprises over 90 qualified professionals with a pharmaceutical and/or regulatory background, as well as over 30 dedicated supporting staff in areas of Business Development, Finance, Business Services and People Practices. We provide services to over 130 organisations, enabling them to achieve their strategic and operational development objectives.
DLRC’s expertise and flexible working approach ensures the provision of a highly motivated team who interact effectively with clients and regulators globally, to support both single issues and long-term commitment to projects.
We are looking to expand our Regulatory Affairs team and are currently looking for a Senior Regulatory Associate to join us on a permanent basis.
This position can be worked on hybrid basis or from our offices in Letchworth, UK.
The role:
The Senior Regulatory Associate will support Regulatory colleagues in working on assigned regulatory projects. This can include projects in clinical development, at MAA filing stage and post-approval lifecycle management.
Responsibilities :
* Oversee regulatory projects on behalf of the client, including direct liaison and negotiation with regulatory authorities
* Manage regulatory procedures at both the national and EU level
* Prepare regulatory submissions including clinical trial applications and amendments, MAA dossiers and variations.
* Assist with preparation of scientific advice requests and PIPs and Orphan drug applications
* Prepare regulatory submissions and agency interactions
* Give input to regulatory plans to meet project and client goals
* Provide support for business development activities
* Provide regulatory strategic advice on guidelines, legislation and procedures to clients on assigned projects.
Required Experience:
* Educated to minimum BSc Level within Life Sciences of Pharmacy
* Previous experience working within Regulatory Affairs
* Previous experience working with activities including CTAs, Scientific advice requests, PIPs and Orphan drug applications is highly advantageous
* Good work ethic & strategic mindset
* Experience working with EU requirements, US highly advantageous
* Commitment to deliver client and company requirements by demonstrating a willingness to help others outside the individual responsibilities
* Ability to work cooperatively with others to achieve overall goals
* Able to clearly and confidently explain complex scientific issues both verbally and in writ ing.
We are a forward-thinking regulatory affairs consultancy, DLRC Ltd takes the time to understand individual needs and find creative solutions for any regulatory challenge.
Selection of candidates & interviews will be conducted continuously so please submit your application as soon as possible.
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