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Regulatory Affairs Registration Manager Belgium,
Keyrus Biopharma (company)
Posted on : 24 June 2017
We are looking for a medior Regulatory Affairs Registration Manager for one of our clients.
The regulatory Affairs Registration Manager is responsible for the maintenance of the worldwide products licenses by ensuring the planning, dispatch, submission, follow up, approval of data packages due to regulatory authorities (variations, commitments, questions and answers, PSURs/PBRERs, risk management plans (RMPs), renewals, Article 46, updated files, WHO annual reports, new dossier requests,...).
Role and main tasks:
- Coordinate and interact with the internal stakeholders (labelling, safety, epidemiology, clinical and technical experts) for the preparation of the documents part of the regulatory dossiers/data-packages in order to meet the submission timelines
- Ensure that all regulatory aspects on the product safety/pharmacovigilance and commitments/obligations to authorities are closely monitored and fulfilled
- Prepare cover letters, application forms, letters of intent, letters to request deadline extensions,... Strong involvement in the CTD Module 1
- Exhibit a very good understanding and ensure alignment with regulatory legislation.guidelines, particularly relating to administrative procedural aspects
- Coordinate, prioritize and plan all the registration activities for the projects within area of responsibility to ensure deadlines are met
- Maintain close contacts with the Local Operating Compagnes's (LOC's) to ensure shared objectives are achieved
- Ensure the tracking of relevant correspondence with Authorities and the Client's Local Operating Companies (LOCs) (in archiving database)
- Communicate with external regulators on specific inquiries.
- Communicate regulatory updated information to internal stakeholders
- Participate in (or lead) the development of the SOPs guidelines, be trained, be a good relay to develop the awareness within the team, act sometimes as a trainer and follow the client's procedures appropriately
- Participate in (or lead) the Regulatory Project Team and gives feedback on their specific areas of expertise
- Be responsible for the Product's Registration activities of one or several projects
- Identify key issues on registration activities that could prevent achieving objectives and proactively propose solutions.
- University Degree (preferably biological/chemical)
- Ideally more than 3 years experience in the pharmaceutical industry; this should include at least 1-2 years RA experience
- knowledge of Regulatory legislation in at least one geographic area
- Team spirit, flexibility and accountability ,very well organized, good relationships, able to work in multi-cultural and multi-disciplinary environment, discipline
- Leadership skills
- Analytical capacity
- Good organizational skills
- Flexible work approach; enjoys varied working day
- Teamwork and collaboration
- Customer oriented
- An eye for detail
- Microsoft Word
- Fluent in English
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.
Walloon Brabant Belgium
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