BD (Becton, Dickinson and Company) International Pharmaceutical Labelling Senior Specialist in Le Pont-de-Claix Cedex, France
Job Description Summary
Work where new ideas are transforming the future of healthcare. From the research lab to the patient bedside, BD and its 65,000 employees have a passion and commitment to help improve patient outcomes, improve the safety and efficiency of clinicians’ care delivery process, enable laboratory scientists to better diagnose disease and advance researchers’ capabilities to develop the next generation of diagnostics and therapeutics. Working for BD, you'll find that every day is a fresh opportunity to make a difference. In 2017, BD welcomed C. R. Bard and its products into the BD family. For more information on BD, please visit bd.com.
We are recruiting 1 International Pharmaceutical Labelling Senior Specialist on 1 year contract initially.
You will be part of a growing team where you will be looking after your own area.
In this role you should be able to interpret an extensive variety of technical instructions and deal with several abstract and concrete variables.
Aside from the above mentioned, we would welcome someone who has excellent verbal and written communications skills, is a strong negotiator and efficient facilitator.
You will be working mainly independently so being a self-starter is not only encouraged, but celebrated! Having to deal with many third parties and internal stakeholder, you would need to be self-organized. Since this role is international, there is up to 25% travel involved. So apply if this sounds like an exciting challenge!
Maintain and develop core labelling documents (CompanyCoreDataSheet, Core Labels etc.)
Coordinate the preparation of new and revised product information for International new registrations and existing licenses. This includes CTD modules 1.3.1 and 1.3.2 (SmPC, PIL, Leaflet, word documents and mock-ups) ▪ Ensure harmonization of world wide packaging elements, in line with company policies.
Provide inputs for process improvements to regulatory procedures related to labelling activities whenever required.
Ensure that the Infection Prevention products sold in international meet the local regulatory requirements and support the local registration of these products in a professional, compliant and timely manner.
Maintain and protect existing licenses ensuring compliance with local regulations
Review and approve change control / design control documentation, with a labeling impact, to ensure regulatory compliance.
Liaise with the Infection Prevention team (local offices or local distributors, manufacturing, quality, R&D, regulatory) to ensure effective submissions 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 Biologist)
Minimum of 4 years of labelling experience in the pharmaceutical industry
Excellent English language skills required. Good command of some other EU languages is a plus.
Knowledge of drug labelling and general pharmaceutical requirements (MAA, variations, renewals, promotion and general GMP principles )– Medical devices and biocides knowledge is also a plus.
Experience interfacing with multifunctional and multicultural groups, including international regulatory agencies is a plus.
What we offer:
An amazing environment with a great team
International projects, and opportunity for growth
An amazing compensation package
Primary Work Location
FRA Le Pont-de-Claix Cedex
BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.