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We are recruiting 1 International Pharmaceutical RA specialists
Prepare and write registration files for pharmaceutical products to be submitted in the targeted markets for Infection Prevention Portfolio.
Maintain and protect existing licenses in international, ensuring compliance with local regulations.
Review and approve change control / design control documentation to ensure regulatory compliance.
Ensure that the pharmaceutical products sold in international meet the local regulatory requirements and support the local registration of these products in a professional, compliant and timely manner.
Liaise with the Infection Prevention team (local office or local distributors, manufacturing, quality, R&D, regulatory) to ensure effective registrations in the targeted markets.
Provide timely support when requested by these organizations in preparing necessary registration documents, submitting these documents in a timely manner and maintaining an adequate archiving system.
Maintain the database in which all registrations made in these territories are documented.
Pro-actively follow up on product registrations and ensure that post-market obligations are met in the territories covered by the business.
Report to his direct manager on the performance of the regulatory process system and registration timelines.
Maintain knowledge of specific regulatory requirements for targeted markets.
When / if applicable, coordinate administrative activities outsourced to consultants
When / if applicable, ensure that sub-contracted distributors / laboratories / consultants are in accordance with the corporate quality and regulatory requirements.
Life science degree (Pharmacist or Chemical Engineer)
Minimum of 3 years of experience in regulatory in the pharmaceutical industry
Knowledge of the development, manufacturing and marketing of pharmaceutical products and the application of technical CMC, non-
clinical and clinical requirements, promotion and labelling requirements and GMP principles
Knowledge of drug pharmaceutical requirements (MAA, variations, renewals Medical devices and biocides knowledge is also a plus.
Experience interfacing with multifunctional and multicultural groups, including international regulatory agencies is a plus.
Must be detail oriented with excellent organizational skills with the ability to analyse regulatory documents (e.g. registration files)
Ability to read professional journals, technical procedures or governmental regulations. Ability to write reports, registration modules and procedure manuals.
Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Reasoning Ability : Able to define problems, collect data, establish facts and draw valid conclusions. Able to interpret an extensive variety of technical instructions and deal with several abstract and concrete variables.
Other skills and abilities : Excellent verbal and written communications skills, strong negotiation and facilitation skills.
Structured and largely self-organized. Strong planning, time management and prioritization skills with the ability to multitask.
Strong computer skills including the office pack processing is required
Excellent English language skills required. Any other EU language is a plus.
Willingness to travel up to 25%