Regulatory Affairs Officer/ Trainee Administrator role, Pharmaceutical
Location: Greater Manchester
Salary: Upto £20,000 DOE
Our Client, a Pharmaceutical - RA company, part of a wider Pharmaceutical group is looking to appoint an administrator who they will train to become an RA Officer. This rare and exciting role will offer career progression and an opportunity to work in the Pharmaceutical sector.
NB; full training will be provided.
- Managing own portfolio of licences.
- Preparing, submit and manage the end to end process for new licence applications/notifications to the MHRA/EMA.
- Preparing, submitting and managing the end to end process for variations/annual updates.
- Preparing, submitting and managing the end to end process for PLPI Renewals /EMA annual updates
- Positive interaction and support to other departments to ensure an effective, streamlined process for all.
- Excellent people skills as interact verbally and electronically with key customers.
- Taking ownership for own personal development to ensure continuous improvement of self and others
- Maintaining and develop own licence portfolio:
- New PLPI Licence applications/EMA notifications - full training to be given but good administrative skills required.
- Liaise with line manager and other team members to facilitate good communication and the elimination of barriers.
- Carry out duties in accordance with the Company's policies and "Procedures Manual" and to report any concerns directly to the Regulatory Affairs Manager.
- On occasion to be flexible by working extra hours or within other areas to meet demands of the business.
- To ensure excellent customer service to our customer base, ensuring that expectations are not only met but exceeded.
- Ensuring own licence portfolio is continuously up to date with the latest requirements from the regulatory bodies and free from errors.
- To ensure documentation is filed and in the correct locations.
- To support with any work which is required when new legislation is passed
- Will hold Grade C or above in English and Maths
- Previous administrative experience
- Good IT skills, Microsoft Office (Word, Excel)
- Excellent English language skills.
- Core competence is spelling.
- Strong organisation skills
- Excellent team, interpersonal skills, and communication skills (Both written and verbal)
- A high degree of attention to detail and strong organisational skills are required.
- Self-motivation but ability to work well in a team is required.
- Proficiency with MS Office
- Problem solving skills