Regulatory Affairs Officer - 782

In the context of our growing activities, we are looking for a Regulatory Affairs Officer to join our teams in Hungary.

Responsibilities

REGULATORY:

Develop local Hungarian Regulatory Affairs presence, taking responsibility for new regulatory activities related to Hungary and EU
Contribute to the regulatory activities performed. Regulatory activities include pre licensing activities, new registration (sites and medicinal products), post licensing regulatory submissions.
Contribute to the production of client administrative documents to be included in regulatory submissions
Compile regulatory dossiers in accordance with national requirements.
Systems Management and Administration
Document and track regulatory submissions and regulatory authority approval.
Provide regulatory support to clients and associate companies
Liaise with sponsor head-office and affiliate departments on regulatory issues.
Provide review of packaging texts.
Provide format review of Summary of Product Characteristics, Patient Information Leaflets, and labelling (e.g., QRD compliance check).
Contribute to data entry in PLG tools enabling measurements of KPI, metrics for regulatory services

PHARMACOVIGILANCE:

Act as point of contact with local regulatory authorities
Responsible for notifying local authorities of appointment
Responsible for keeping up to date with local regulatory requirements
Support/Contribute to pharmacovigilance (PV) activities performed by the Medical Information & Vigilance Pillar /the Hub in local country
Creation and maintenance of local PV system, including creation of a local SOPs and agreements
Safety case receipt, translation, tracking and ICSR follow up.
ICSR reporting to local regulatory authorities (outside EU)
Local literature/journal review
Provision or support of medical information services
Contribute to the production of client administrative documents, reports and tracking tools
Liaise with client, affiliate departments and other 3rd party vendors
To comply with client and PLG policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives

Bachelor’s degree or more in a Life Sciences related field.
At least 2 years of experience in Regulatory Affairs in the Pharmaceutical Industry or via a Service Provider
Previous experience in a consulting company would be a plus

Hard/Technical skills:

Native Hungarian mandatory along with fluent English
Experience in regulatory lifecycle maintenance activities for drug products (Renewals, PI updates, technical variations)
Knowledge of Hungary’s regulation for pharmaceuticals (NCE, Biologicals and Biotech) and Medical Devices
Strong computer skills, including MS Office applications, data and document management systems (Veeva or comparable EDMS, LorenZ, Trackwise, etc)
Experience of promotional/non-promotional activities would be an advantage

Soft skills:

Excellent organizational skills
Effective oral and written communication skills
Ability to work well within a team
Process oriented with good attention to detail
Ability to prioritize different workloads/multi-task
A proven ability to consistently deliver to tight timelines, without negatively impacting on the quality of the work
Solution-driven