Direct message the job poster from DLRC Regulatory Consultancy
Established 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 an experienced Regulatory Consultant to join us on a one-year fixed contract or a permanent basis.
This position can be worked on hybrid basis or from our offices in Letchworth, UK.
The role
The Regulatory Consultant will be responsible for managing a portfolio of projects for a number of clients. This will include labelling management but may also encompass projects in clinical development, at MAA filing stage and post approval lifecycle management.
Responsibilities:
· Lead and support regulatory projects on behalf of the client including liaising and negotiation with regulatory authorities
· Manage and support regulatory procedures at both the national and EU level
· Manage and support US projects as required
· Prepare and oversee the development and maintenance of core data sheets, and core patient product information as well as local product labels throughout the product lifecycle
· Ensuring regulatory compliance as required
· Prepare regulatory submissions and agency interactions
· Provide regulatory strategic advice on guidelines, legislation and procedures to clients on assigned projects
· Analyse changes in the regulatory environment and legislation for impact on project/plans and the overall business
· Prepare and manage regulatory submissions and agency interactions
· Develop regulatory plans to meet project and client goals.
Required Experience:
· Educated to minimum BSc level within Life Sciences or Pharmacy.
· Previous experience working within Regulatory Affairs
· Previous experience of developing and maintaining global labelling content
· 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
· Analyse and understand current and future regulatory environment and its impact on assigned projects and apply to the business environment.
Seniority level
* Seniority level
Not Applicable
Employment type
* Employment type
Full-time
Job function
* Job function
Science, Research, and Consulting
* Industries
Business Consulting and Services, Pharmaceutical Manufacturing, and Biotechnology Research
Referrals increase your chances of interviewing at DLRC Regulatory Consultancy by 2x
Get notified about new Regulatory Affairs Consultant jobs in Letchworth, England, United Kingdom.
Regulatory Affairs Senior Specialist (m/f/d)
Huntingdon, England, United Kingdom 2 weeks ago
Cambridge, England, United Kingdom 3 weeks ago
Regulatory Affairs Manager – Oncology Cell Therapy
Cambridge, England, United Kingdom 2 weeks ago
Regulatory Affairs Liaisons Manager- Global Therapeutic Area (TA)
Cambridge, England, United Kingdom 1 week ago
Sr. Manager, Regulatory Affairs Labeling Execution (Vendor Management)
Cambridge, England, United Kingdom 2 days ago
St Albans, England, United Kingdom 3 weeks ago
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr