Role and main tasks:
- Administrative office routines:
- Assist in compilation and submission of regulatory documents to the local regulatory authorities and – as applicable - to the European Medicines Agency (EMA) related to new applications, variations, renewals etc.
- Assist in department administrative tasks, such as managing invoicing, meeting arrangements, coordinate agendas, take and circulate minutes, travel arrangements, as applicable.
- Builds and maintains standard Regulatory Official Files as well as Marketing Authorization filing and approval binders according to local SOPs.
- Ensures that regulatory databases and systems are kept updated and complete.
- Participates in establishing and maintaining of relevant SOP to secure that the current regulations are complied with.
- Participates in implementation of updated regulatory documentation according to Agency requirements and in-house guidance.
- Adequately support other functions as applicable to enable compliance in areas related to regulatory, such as PSUR submissions and review of promotional material.
- Editing and labeling:
- In connection with submission of MA applications, variations and renewals etc assists in preparation, translation and QRD check of Summary of Product Characteristics and Patient Package Leaflets and performs quality assurance including linguistic check of these documents.
- Co-ordinate Electronic Medicines Compendium submissions, approvals and record keeping.
- Art-work development:
- Ensures that artwork including all package components (leaflets, labels, outer cartons etc), is developed in a timely and correct manner and according to relevant Artwork Management procedures.
- Read packaging components and is responsible for maintaining an updated file on packaging components, as applicable.
- Responsible for giving general support to the Quality Responsible Person (QRP) / subsidiary contact for quality issues (QCP) with respect to administrative and practical issues on key activities.
- Responsible for giving general support in handling customer's complaints in close cooperation with Customer Service and/or PhV and under supervision of the QRP/QCP and/or under supervision of Country Lead/Associate Director/Manager Regulatory Affairs and MMD.
- When necessary cooperates with QP at wholesaler/distributor/importer level, or Management (Crisis) team.
- Responsible for handling of practical issues related to procedures for free medical samples/reference standards under supervision of the QRP/QCP.
- This responsibility also includes regular interactions with the wholesaler/customer service.
- Under the supervision of the QRP/QCP, Responsible for free medical samples training and communication with marketing, as well as other internal support as appropriate (e.g. internal product orders).
- Post-secondary education in scientific science or equivalent
- Minimum of 2 years experience in a Registration Department, dealing with most aspects of registration, with sufficient working knowledge of the subject area to require minimal supervision from a manager
- Proficiency in local and English language as well as PC use with regard to word-processing, spreadsheets, database applications, and internet
- Basic medical and scientific understanding and knowledge
- Basic skills and knowledge of local and EU medicines legislation and regulatory procedures
- Ability to plan and prioritize regulatory tasks to meet the group and local objectives
- Good interpersonal and managerial skills, capability of problem resolution and the ability to work in a team environment
- Commitment, dedication to quality an d the ability to handle multiple priorities simultaneously
- Appreciation of the interactions and relationships of the dept with other groups internally
What we offer
- You will receive a competitive based salary depending on your education and experience in an attractive package of extralegal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…).
- Each employee will be welcomed with a varied integration program.
- We invest considerable time and resources in training our staff (technical and non-technical courses).
- You will join a dynamic and international environment with enthusiastic and professional colleagues.
Who We are
- Our company is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence.
- Our ‘human’ approach to service provision is what differentiates us from our competitors.
- Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.
- We’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better
- From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Bio statistics, Medical Writing & Medical Information, Real World evidence services.