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Job Description Summary

Job Description

International Pharmaceutical RA CMC Senior Specialist                                                         

Eysins, Switzerland

A superb, wide-ranging International Pharmaceutical RA CMC Senior Specialist

 career development role with BD, a global leader in Medical Technology.

BD is a global medical technology company focused on improving drug therapies, enhancing the quality and speed of diagnosing infectious diseases, and advancing research and discovery of new drugs and vaccines.  BD provides an environment which enables our highly talented workforce to be the best at their professions. We are always seeking people who have a passion and commitment to join our Company on its journey to ‘helping all people live healthy lives’.

Responsibilities:

• Prepare and write the CMC sections of the registration files for Pharmaceuticals products to be submitted in the targeted markets for Infection Prevention Portfolio


• Maintain and protect existing licenses in international, ensuring compliance with local regulations.


• Support the Change control / Design control process as needed, to ensure Regulatory compliance


• Ensure that the Pharmaceutical products sold in those countries meet the local regulatory requirements and support the local registration of  these products in a professional, compliant and timely manner, provide advice to the local business and regulatory organizations


• Liaise with the Infection Prevention team (local office, marketing/sales organization or local distributors, US manufacturing) to ensure effective products international registrations outside of the US.


• Provide timely support when requested by these organizations in preparing necessary CMC 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 will be documented.


• Pro-actively follow up on these products registrations and ensure that post market (file maintenance/variations) obligations are met in the territories covered by the business.


• Report to his direct manager on the performances of the Regulatory process system and registration timelines.


• Maintain knowledge of specific regulatory requirements for targeted  markets


• When/if applicable, ensure that sub-contracted distributors / laboratories / consultants are in accordance with the corporate quality and regulatory requirements.

Profile:

• Life science degree (Pharmacist or Chemical Engineer),


• Minimum of 5 years of experience in Regulatory in Pharmaceutical industry 


• Knowledge of the development, manufacturing and marketing of pharmaceutical products and the application of technical CMC, 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


• 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%

It’s a superb, all-roundInternational Pharmaceutical RA CMC Senior Specialistcareer development role with a world leader in medical devices.  So if this describes you and your aspirations, then please click on the APPLY button.

Primary Work Location

CHE Eysins - Business Park Terre-Bonne

Additional Locations

Work Shift