Regulatory Affairs/ Administrator, Pharmaceutical
Our Client, a multi- sited Pharmaceutical company and part of a consortium; is looking to recruit for a RA Officer to complement the existing QA and RA function/s. This is a viable move into Pharmaceuticals, an industry which has been thriving throughout the pandemic, it is also an opportunity to gain invaluable skills in RA.
- Manage own portfolio of licences.
- Prepare, submit and manage the end to end process for new licence applications/notifications to the MHRA/EMA.
- Prepare, submit and manage the end to end process for variations/annual updates.
- Prepare, submit and manage 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.
- Take ownership for own personal development to ensure continuous improvement of self and others
- Maintain 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.
- ESSENTIAL, previous administrate experience, with proven experience using a diverse range of IT programmes, CRMs etc. Excel experience considered essential.
- This person will be required to do a lot of cross checking and document checking, therefore must have strong spelling and linguistic skills.
- The successful candidate will be required to communicate to key stakeholders within the business; they will be extraverted and have stolid interpersonal skills.
- Will be educated to a minimum of GCSE level.