Job Details
A Global Pharma company are presently looking for an experienced Regulatory Consultant to work on a post license registration project. The role can be based in Croatia, Lithuania or Czech Republic.
Purpose
*Contribution to the development and implementation of commercial objectives and strategies in country.
*Management of new registrations and product licence maintenance activities.
*Notification to Poison Centres or Ministry of Health for Cosmetic products, Medical Devices and Commodities.
*Provision of regulatory and scientific advice to, and liaison with, key customers.
*(Possible) Processing of medical information queries and adverse event reports received by the local Consumer Company for its marketed products.
KEY RESPONSIBILITIES
Business/Marketing strategy - launch plans
oSupport and regulatory inputs for business and launch planning, as required.
Regulatory strategy - local strategic inputs to local and regional plans
oParticipation in local and regional strategic regulatory planning, as required.
oProviding regulatory and legislation insights.
oTo work with local and EMEA Regional R&D and local teams thus ensuring local needs are considered in Global / Regional regulatory strategies which support the strategic planning process, local inputs to dossier development.
Regulatory intelligence - legislation, competition
oTo provide regulatory intelligence and lobbying activities e.g. liaising with local market-based colleagues, professional staff at regulatory agencies etc to facilitate the review and approval of regulatory submissions. To play an active role in lobbying governmental and professional bodies proactively for aggressive growth brands and other brands, as necessary. Active role in interpretation of legislation for local market and EMEA HQ.
oMonitoring of emerging legislation changes affecting OTC, CHC and Cosmetics business and communication to relevant internal customers.
oImplementation of existing legislative in working practices.
Scientific support to the business, local and EMEA HQ
oMain partner and advisor for business in building consistent claim strategy.
oCooperation with business in development of promotional materials.
oSigning off promotional materials.
oContact person for medical question/queries and surveys coming from EMEA HQ (legal status Rx/OTC, policy strategies, claim strategies etc).
Interaction with Authorities
oManaging excellent working relationship with authorities, external experts and` others involved in regulatory review and decision.
oTo ensure that the company's regulatory and statutory requirements are met.
oTo ensure that product licence maintenance activities, medical marketing and complaints are properly handled in accordance with local and EU legislation.
Operational functions
Product maintenance - Variations
oSubmission, process tracking, communication with Authorities and EMEA HQ according to Company SOPs.
oActive role in interpretation of queries raised by authorities.
Renewals
oSubmission, process tracking, communication with Authorities and EMEA HQ according to Company SOPs.
oActive role in interpretation of queries raised by authorities.
New registrations
oSubmission, process tracking, communication with Authorities and EMEA HQ according to Company SOPs.
oActive role in interpretation of queries raised by authorities.
Are you available or interested?
To Apply:
To apply, please click on the Apply button. Ideally, 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 Luke Webber on +44 (0) 207 440 0635 or upload your CV on our website. Full description available on request.
Please note that not all of our vacancies are advertised. To register as a priority candidate, please upload your CV on our website with a short description of what you are looking for or call 0800 988 4437. We will then contact you with relevant roles: www.proclinical.co.uk. We regard all correspondence as confidential.
Proclinical is a specialist Employment Agency and Recruitment Business, providing employment opportunities within major companies in the Pharmaceutical and Biopharmaceutical industries across Europe.
