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Head of Regulatory Affairs
Leads interface for all regulatory matters between regulatory authorities and the company.
Leads the local RA team - Providing oversight of the RA workflow and personal development of associates.
Ensures all regulatory applications and actions are conducted to the highest compliance and ethical standards.
Leads alignment & collaboration with RA GDD across all divisions as part of the GDD working model and in line with the local, regional and global strategies.
Initiates and expedites all product license submissions with the aim of registering the Company’s products. Manages and works with the RA team in the planning, reviewing, editing and compilation of summaries, study reports and other technical information to create coherent information packages for regulatory applications.
Defines content, compiles and assists in the compilation of high quality dossiers for sub-mission/resubmission to the relevant EU and National Health Authorities for products in order to obtain fastest possible approval with the most appropriate labelling for new product licences, licence variations, licence renewals, in accordance with current European and local regulatory standards.
Working closely with global and local colleagues cross-functionally to advise and agree on regulatory strategy, clinical development plans and data requirements. Participation in regional RA subteams.
Where applicable organises and participates in health Authority scientific meetings with global teams to support product development programs.
Works closely with local brand teams to ensure launch readiness plans are in place in order to successfully launch products
Provides regulatory intelligence and offers maximum opportunity to optimize regulatory strategy in Belgium.
Interacts with external consultants, third parties /contractors and Novartis affiliated entities as needed.
Commits, complies and ensures team’s adherence with all company Policies and Guide-lines with regard to the Code of Conduct, Corporate Citizenship, NP4 and other global and local policies and guidelines, Code of Ethics and National Legislation.
Represents the company at local Pharma Trade Association bodies for regulatory relevant agenda
In line with personal demonstrated capability & RA Region Europe priorities, this Country RA GDD Head role scope can be expanded to a RA GDD Head role for a cluster of countries.
PHARMASPECIFIC TECHNICAL RESPONSIBILITIES
Reviews and provides input to business activities (e.g. pricing, reimbursement & formulary listing...) in reference to regulatory requirements.
Monitors published and other sources (e.g. National Medicines Agency, EMA, FDA etc.) for changes to guidelines and regulations. Responsible for analyzing and communicating new regulations and guidelines in the organization.
Represents the regulatory function on assigned project teams and provides expert guidance on local and/or international requirements.
Ensures effective and productive collaboration and exchange of information between Medical Affairs, Pharmacovigilance, Medical Information, Trial Monitoring Organization (TMO), Quality Affairs, Supply Chain, Legal and Compliance, Market Access and commercial groups for operational excellence and highest standards. Provides regulatory exper-tise to review and optimize promotional material. Ensures the clearance for promotional materials and activities in full compliance with the SmPC, SOPs, NP4 and local laws and regulations.
PEOPLE MANAGEMENT RESPONSIBILITIES
Leads, motivates, sets objectives and manages performance of the team to assure completion of organizational goals.
Responsible for developing staff to improve their individual and team performance (eg. coaching, through performance reviews, development planning, etc).
Collaborates actively with medical/patient access & other line functions to provide the best-in-class product patient access outcome for the Belgium market.
Skills and personality
Minimum degree acceptable: Medical, Pharmacy degree / Scientific Master’s degree
- At least 5-10 years of regulatory experience in the pharmaceutical industry, of which no less than 2-3 years in a senior management role.
- Sufficient experience in registration as measured by proven proficiency in leadership, registration execution and regulatory affairs development.
- Strong understanding of the regulatory environment in the country as well as established contacts within the regulatory bodies.
- Thorough understanding of the international aspects of RA processes, including expert knowledge of international standards, health authorities (FDA, EMEA), local/ National Health Authorities regulations and the company’s standards.
- Understanding of local patient access context.
SKILLS & COMPETENCIES
- Excellent organizational, communication, negotiations and interpersonal skills required.
- Able to prioritize and work effectively in a constantly evolving environment and multiple priorities
- Ability to guide, coach and develop people to ensure accomplishment of optimum performance and realization of the company’s needs and objectives.
- Ability to build and maintain excellent relationships across matrix organization and with local Health Authorities.
- Computer literacy essential.
+- 10 years
Higher Scientific Degree
Dutch, English, French
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