Graduate Regulatory Executive
Competitive starting salary and benefits package
You will support the whole Regulatory team in working on a variety of assigned regulatory projects. This can include projects in clinical development, at MAA filing stage and post-approval lifecycle management.
- Support regulatory projects on behalf of the client including supervised liaison and negotiation with regulatory authorities.
- Assist in the preparation of 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.
- Provide support for business development activities.
- Analyse changes in the regulatory environment and legislation for impact on project/plans and the overall business.
- Assist in managing regulatory submissions and interactions.
- Give input to regulatory plans to meet project and client goals.
- Assist in developing regulatory plans to meet project and client goals
- Ensure relevant policies and procedures are in place and adhered to in order to meet the Company’s legal responsibilities
- Strong analytical skills; able to review large data sets and identify errors, inconsistencies and missing information
- Attention to detail; able to work accurately
- Accountability for individual parts of the project
- Ability to work cooperatively with others in order to achieve overall goals
- Receptive to ideas, feedback and contributions
- Commitment to deliver client and company requirements by demonstrating a willingness to help others outside the individual responsibilities
- Sharing knowledge and keeping stakeholders up to date with current project status
- Foster good interpersonal relationships.
- Build trust and respect with peers and clients through good communication.
- Ability to clearly and confidently explain complex scientific issues both verbally and in writing.
- Recent Graduate with a Life Science or Pharmacy Degree
- Full UK driving licence
- Qualified to work in UK
- Fluent in English
If you meet the outlined requirements and are interested in this position then please feel free to send your CV to firstname.lastname@example.org or if you have any questions regarding the role then please call 0118 959 4990.
If this role is not quite right for you, but you are interested in hearing about new career opportunities, then please still get in touch as further roles are available. Additionally, if you know someone that may be interested in this role then please feel free to pass this advertisement on.
- Agency: Clinical Professionals
- Contact: Stephen Wincott
- Reference: JO-1804-406757
- Posted: 31st May 2018
- Expires: 28th June 2018