Senior Regulatory Consultant
Company: ProClinical Ltd
Closing Date: 08 Dec 16
Salary (£): Competitive
Here is an exciting job opportunity to join a successful and innovative company in the health care industry who are looking to hire a Senior Regulatory Consultant based in Cambridgeshire, UK. Job Role:
Liaise and provide regulatory services, advice and information to the local Companies. ...
Here is an exciting job opportunity to join a successful and innovative company in the health care industry who are looking to hire a Senior Regulatory Consultant based in Cambridgeshire, UK.
- Liaise and provide regulatory services, advice and information to the local Companies.
- Undertake UK and Ireland regulatory activities as required by the local Companies and the R&D project teams
- Prepare Marketing Authorisation (MA) Applications (and Clinical Trial Applications, where appropriate) for submission.
- Respond to questions from Regulatory Authorities
- Perform maintenance activities for MAs (and Clinical Trial approvals, where appropriate).
- Liaise with third party companies where UK and IE are the local distributor.
- Liaise with the RAST leaders and CMC leads as appropriate
- Maintain records of tasks and registered product information in the internal regulatory databases.
- Provide UK/Ireland specific guidance and advice to the wider Regulatory Affairs department, R&D project teams and the local Companies
- Maintain awareness of the current priorities and regulatory needs of the UK and Ireland IAC.
- Plan, coordinate and prepare MA Applications for submission via National procedures.
- Provide advice and prepare local documentation for MA Applications for submission via European procedures.
- Coordinate and respond to questions from Regulatory Agencies during MA applications, MA renewals and variations.
- Management and submission of all national phase activities following the completion of DCP/MRP procedures.
- Manage the UK and IE Artworks through the Bard Artwork Management System (BART)
- Manage the maintenance of SmPC and PIL texts on the local websites (eMC/ Ipha)
- Keep up to date with current relevant legislation and regulations and provide expert advice on items which will affect Regulatory, R&D project teams and the local Companies.
- Take a high degree of personal responsibility for representing the Department with both internal and external key stakeholders.
- Displays the leadership attributes in particular ownership and responsibility, and flexibility and works by Company values.
- Participate in project teams and provide guidance in areas of expertise for both research and marketed products.
- Undertakes any other reasonable tasks as required by the RA line manager
- Raise issues related to area of expertise with the appropriate Regulatory Affairs team members and perform actions to address these issues, as agreed.
- Ensure where appropriate that the electronic document management system is used for all submission documents.
- Take responsibility for personal training and development in order to reach and maintain the required skills, knowledge and experience to perform the role.
- Point of contact for both product and non-product specific queries with the local companies (Bard, NPL and MPL) and internally from MRL.
- Point of contact within regulatory for Research Quality Assurance (RQA) for on-site audits.
Skills and Experience:
- Science degree or equivalent qualified: e.g. chemical and physical sciences, pharmacy, biochemistry, medical chemistry, biomedical science; or HND or equivalent industry experience where appropriate.
- High level of technical regulatory experience.
- Excellent understanding of relevant Regulatory Guidelines and legislation.
- Excellent analytical and problem-solving skills.
- Ability to influence internal and external bodies.
- IT literate particularly in relation to using databases and document management systems.
- Taking personal responsibility and accountability for managing and delivering Regulatory projects.
- Project managing and leading tasks.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Elise Lambeth on +44 207 4400 633 or upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.