job details for:
Pharmaceutical - Regulatory Affairs Manager Jobs - Home Based/Middlesex

Pharmaceutical - Regulatory Affairs Manager Jobs - Home Based/Middlesex (Job Ref: WR/JOBS/25233-11638)

Job Description :

Flame Pharma Pharmaceutical - Regulatory Affairs Manager Job - Home Based/Middlesex:

Job Summary

UK: Salary up to £55k

Flame Pharma is working alongside a multi-faceted drug manufacturing organisation with over 5200 dedicated employees, to recruit a Regulatory Affairs Manager to work independently in the UK reporting to the Head of Regulatory based in India. In addition to the above, this client also has the state-of-the-art facilities and R&D centres’ with international standards, in the suburbs of a beautiful metropolitan city in South India.

The Role

Reporting to the Head of Regulatory affairs who is based in India, this is foremost a very autonomous role. You will track the timelines for submission on dossiers with RA/marketing at corporate office, decide on Regulatory strategies for new products – Centralised, MRP, DCP or National application and applying for slots accordingly. You will coordinate with the local agents for translation of SPC, PIL and labelling for readability testing. This role requires submission of dossier to various health authorities either directly or through local agents & communicating with health authorities during the procedure and after MA is received along with submitting deficiencies as per the procedural timetable. You will coordinate with EU labs on method transfers during procedure or after MA is received & with QP for Quality and QP for Pharmacovigilance for related work as well as working with marketing and the agents for final mock ups of packaging materials & submission of variation documents and tracking.

You will keep a record of annual maintenance fees, renewals and submissions, arrange appointments with health authorities for scientific advice as and when required & maintain copies of all Confidentiality and technical agreements with clients, QP, Labs and batch release site. This role requires monitoring of finished Goods product quality at local batch release site to ensure that adequate conditions of storage and handling are complied with. You will be in charge of the preparation of Documents needed during Annual and routine inspections conducted by the Inspectors from authorities and attend continuing educational program /seminars for awareness on the present trend in the pharmaceutical industry. This role also requires that you coordinate with local patent attorney as and when required & handle regulatory requirements of in-licensing and out licensing products with marketing and clients.

The Person

You will be a Regulatory Affairs Manager with direct experience of working within a generics Pharmaceutical environment. Due to the autonomy & flexibility of this role you will have extensive experience of the afore mentioned daily requirements. You will be required to report into a manager based in India. You will also be required to visit the Middlesex office at least once a week.

Key Words

Regulatory Affairs, Senior Regulatory Affairs Consultant, Pharmacovigilance, Drug Safety, Director, Manager, Management, Clinical Research, Clinical Trials, Medical, Clinical, CRO, Study Management, Clinical Management, Pharmaceutical, Career, Research, Home based, Job, Recruitment