Job Description Summary

World Health Authorities are drastically changing their regulations and registration processes, and continually expanding their licensing requirements, especially regarding sterile and injectable forms.
Harmonised or country-specific regulatory requirements applicable to medical devices and medicinal products, and in particular sterile and injectable combination products, are constantly evolving and becoming more stringent.
As a consequence, the demand of the Pharmaceutical Industries (our customers) for customized solutions to cover their need for "Regulatory Affairs" is growing sharply. These include advice on "regulations" related to injection systems, projects of new drug development or changes in primary packaging. But also personalized customised support in the preparation of registration files answers to questions from Global Health Authorities and support for the management of change/variation.
BD's "Medical - Pharmaceutical Systems" unit is recruiting a Regulatory Affairs Specialist to join our team in Pont-De-Claix.

Job Description

As Regulatory Affairs staff for the Pharmaceutical Systems Regulatory Affairs team, your mission, in collaboration with a cross-functional customer-facing team (sales, quality, supply & marketing) and with the support of technical functions (medical, R&D & quality) is to support regional customers located in Greater Asia and in particular:

• Provide fast & accurate solutions to customer registration challenges (submission, variations, response to questions) in key geographies targeted by customers (GA customers target WW markets)
• Deliver unique regulatory affairs Services

In addition to this you will:

• Ensure state of the art knowledge and expertise of target market regulatory requirements
• Provide regulatory insight, interpretation and advice to technical/supportive teams internally on new/updated regulatory requirements

In this context, these missions cover the following roles and responsibilities:

1- Customer interface :

• Management of a small number of major customers: in-depth knowledge of the customer and its current situation, communication, network creation and maintenance
• Customised support for customers via adapted regulatory solutions and with a particular focus on the submission of new products as well as the change management and submission of variations

2- Regulatory Affairs Expert:

• Management of a part of our portfolio of regulatory expertise related to key topics for the company
• Support for the global regulatory strategy of our existing products or in development
• Develop and train team on regional expertise on country-specific requirements in one or two GA countries.

Your Profile

You are a Pharmacist or Engineer; you have 3 to 5 years of experience ideally in Regulatory Affairs within a medical device or drug industry. Ideally, you have participated in the submission of new registration files or variations to Health authorities in EU, US and/or another key-geography.

You are curious and open to learn with a good understanding of the pharmaceutical industry market.

You are solution-oriented, can arbitrate priorities and are comfortable prioritizing multiple projects simultaneously.

Excellent communicator, you know how to be an ambassador for the Regulatory Affairs function.

Your team spirit and customer relationship management allows you to develop your network with internal and external counterparts.

You are proficient in English.

Do you see yourself in the above, we encourage you to apply today!

Primary Work Location

FRA Le Pont-de-Claix Cedex

Additional Locations

Work Shift