Regulatory Affairs Specialist
il y a 4 jours
**Job Description Summary**: With advanced pre-fillable syringes, self-injection systems, safety systems and needle technologies, the Pharmaceutical Systems (PS) team offer a wide array of solutions designed to protect, package and deliver drug therapies.
The Regulatory Affairs Specialist's role is to support the registration of new products (including pre-fillable syringes, piston seals, accessories, packaging) and the maintenance of existing products. Regulatory Affairs Specialist ensures the provision of Regulatory deliverables throughout the product life cycle.
**Excited to grow your career?**
We value our talented employees, and whenever possible strive to help one of our associates grow professionally before recruiting new talent to our open positions. If you think the open position you see is right for you, we encourage you to apply
- Our people make all the difference in our success._
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.
**We are the makers of possible**
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.
**Why Join Us?**
A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.
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 health. At BD, you’ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.
Become a maker of possible with us
**Responsibilities**
- Prepare regulatory submissions (eCTD and non-eCTD) and maintain regulatory dossiers (US, Canada, China, Technical Dossier).
- Participate in product lifecycle activities such as change impact assessment and ensure timely update of regulatory dossiers.
- Support pharma customers in securing a timely response addressing health authority questions.
- Support the commercial Regulatory Affairs team in connection with areas of expertise.
- Collaborate with RA Core Team Members to ensure timely execution of regulatory submissions with business objectives and customer deliverables.
- Develop and maintain knowledge and awareness on the assigned areas of expertise: identify applicable regulations and standards, carry out regulatory monitoring, assess the regulatory impact of changes, inform the appropriate internal and external stakeholders.
**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
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.
Management Level
JG 3 (P2/P3/M1)
**Required Skills**:
Optional Skills
**Primary Work Location**: FRA Le Pont-de-Claix Cedex
**Additional Locations**:
**Work Shift**:
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