Regulatory Affairs Consultant
- South East
- Contract
- Drug Safety / Pharmacovigilance
This vacancy has now expired
The successful candidate will be responsible for supporting the Senior Regulator Affairs Officer with a variety of regulatory activities listed below.
Role:
- Support submissions of initial marketing authorisation applications and variations
- Creating, updating and reviewing labelling, package leaflets and summary of product characteristics, ensuring compliance with current legislation and registered particulars
- Compiling responses to enquiries and deficiencies from regulatory bodies
- Creation and maintenance of product registration files
- Provide regulatory advice and guidance, when required
- Carry out administrative activities where necessary to ensure the effective operation of the department
- Support with quality and compliance related matters
- BSc. or MSc. In Pharmacy, Chemistry or related science
- Ability to communicate effectively with internal functions and external partners
- 2 years+ experience in local Regulatory Affairs/ dossier registration, preferably within generics
- Good knowledge of post-marketing authorisation maintenance including variations (Type IA/Type IB/Type II and PIQ notification/full applications) and renewals
- Experience of liaising with the MHRA PIQ Unit is desirable
- Working knowledge of regulatory database management is desirable
- Candidates should be willing and able to travel as necessary
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I have always received a highly professional & personable service from the team at Quanta. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
We have worked together with Quanta for seven years now and have always received a professional service. Quanta’s speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
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Ben
I manage this role.