About the Role

　　Job Purpose:

　　Ensure that new medicines are registered and maintaining existing medicine registrations.

　　Key Responsibilities:

　　Assess (parts of) draft registration dossiers and advising on them head office in this regard;

　　• Submit (amendments to) registration dossiers with a scientific substantiation for the government and guidance of the registration procedure in order to obtain and maintain registration through interaction with the (inter)national government and the head office case of reservations;

　　• Assess and, if necessary, advise on adjustments to the chemical-pharmaceutical part of registration files and drafting associated letters with argumentation to the Medicines Evaluation Board (MEB) and to the head office;

　　• Draft and update the SPC text (and abbreviated SPC text), package leaflet text and packaging texts of medicines from Novartis Pharma B.V. and the drafting accompanying letters with arguments;

　　• Ensure adequate data management (including DRAGON);

　　• Share relevant information with QA and SCM to ensure safety and security availability of medicines from Novartis Pharma B.V. on the market, including the timely initiation of Change Controls;

　　• Ensure compliance with the Risk Management Plan and associated educational materials in collaboration with the RMP manager ensures timely assessment (leading to approval) by the MEB of the educational materials

　　• In collaboration with the Local Drug Safety Responsible, assess it in a timely manner submitting Periodic Safety Update Reports to the MEB;

　　• Responsible for obtaining approval from the MEB of the DHPC and coordinating its distribution internally;

　　• Requesting and supporting scientific advice from the CBG;

　　Contribute to Novartis Pharma's strategic plan regarding timing, opportunities and threats regarding registration technical matters from both our own and competitors products, including Regulatory Advocacy;

　　• Checking packaging material and package leaflets in accordance with the quality requirements set by Novartis Pharma and the legislator;

　　• Assessing the medical scientific accuracy and conformity with the SPC of promotional material, with regard to the Medicines Act and the Code of Conduct for Medicines Advertising;

　　Maintaining contacts and sharing relevant information with the disciplines involved, internally and externally, nationally and internationally (marketing, medical, clinical, head office, R&D, governments and external experts), also via databases and reports.

　　• Carrying out various activities, including:

　　o providing (bio)pharmaceutical information at the request of the Medical Information Service; ensure the registration technical input with regard to the IMPD for the medicines in clinical research;

　　o participate in (inter)national consultation structures both within and outside the Novartis Pharma organization (such as membership of international DRA sub-teams);

　　o preparing and holding (inter)national presentations (including for training new employees);

　　o timely attendance of compliance training;

　　o writing and maintaining DRA-related local SOPs

　　o writing and maintaining DRA-related local SOPs; Build up and maintaining knowledge of relevant legislation and guidelines and providing advice from the organization on its applicability for Novartis Pharma Products.

　　• Initiate and implement relevant Annual Quality Plans.

　　Key Performance Indicators:

　　• Actual submission date versus planned submission date (new registration dossiers, CMC variations, PSURs, CDS updates including the standard and urgent safety changes).

　　• Obtain timely registration/approval of national products & variations

　　• Internal handling of approvals obtained (checklists completed on time: change controls initiated on time)

　　• Customer satisfaction (including initiators of promotional releases)

　　• Input to Brand team/Market Access team, DRA sub-team

　　• Compliance data management

　　Diversity & Inclusion / EEO

　　We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

　　Role Requirements

　　Education & Qualifications:

　　Minimum education: Scientific (Bio-Medical)

　　Desired education: Preferably Pharmacist

　　Languages:

　　Fluent in Dutch and English, orally and in writing

　　Experience:

　　Preferred minimal 2-4 years of experience within Regulatory Affairs from pharmaceutical industry or Health Authorities

　　Division

　　Development

　　Business Unit

　　REG AFFAIRS GDD

　　Location

　　Netherlands

　　Site

　　Amsterdam

　　Company / Legal Entity

　　Novartis Pharma NL

　　Functional Area

　　Research & Development

　　Job Type

　　Full Time

　　Employment Type

　　Regular

　　Shift Work

　　No