We are the people who give possibilities purpose

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Job Description

As a Regulatory Affairs Specialist at BD Medical Pharmaceutical Systems, you will play a pivotal role in life cycle management of BD files (EU, US, China), ensuring regulatory submissions to Health Authorities based on change control or regulatory strategies.

You will collaborate with cross-functional teams and local regulatory experts. You will engage with Health Authorities and interact with BD pharmaceutical partners.

Responsibilities

• Provide regulatory support to pharmaceutical customers in EMEA through close collaboration with cross-functional teams (Sales, Quality, Supply Chain, Marketing) and technical experts (Medical, R&D, Quality).
• Ensure efficient and timely support to customers for the registration of drug-device combination products for new submissions and variations across global, customer-targeted markets.
• Support pharmaceutical customers in securing a timely response addressing health authority questions.
• Contribute to DEO execution in the role of a Regulatory Affairs contributor, including the presentation of strategic DEOs to relevant business platforms and segments.

Preferred Requirements

• You are a Pharmacist or an Engineer; you have 1 to 3 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 the Health Authorities worldwide and you are familiar with eCTD structure.
• You are detail oriented, with emphasis on accuracy and completeness
• You can use time productively and efficiently (structured and self-organized)
• You can make appropriate regulatory decisions under pressure with minimum supervision
• You have ability to adapt, multitask and respond quickly in a rapidly changing and often ambiguous environment
• You are self-motivated by working independently and having the ability to take ownership of responsibilities
• You have excellent written and verbal communication skills
• Proficient in oral and written English

Salary range for the role: 37 100€ to 42k€

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visit https://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

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At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."

Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.

Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

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