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BD (Becton, Dickinson and Company) Sr Regulatory Affairs Specialist in Franklin Lakes, New Jersey

Job Description Summary

Job Description

Be part of something bigger!

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

Job Summary:

World Health Authorities are drastically changing their regulations and registration processes, and continually expanding their licensing requirements, especially regarding sterile and injectable forms.

Harmonized 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 customized 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 Franklin Lakes.

Your mission:

As Regulatory Affairs specialist 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 the US and in particular:

  • Provide fast & accurate solutions to customer registration challenges (submission, variations, response to questions) in key geographies targeted by customers (EU, US, Canada and some GA markets such as Korea, Japan or China)

  • 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/encouraging teams internally on new/updated regulatory requirements

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

1- Customer interface :

  • Management of a large number of regional customers: knowledge of the customer and its current situation, communication.

  • 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

  • Develop and train team on regional expertise on country-specific requirements.

Requirements:

  • This position requires a Bachelor's Degree or higher

  • You are a Pharmacist or Engineer; you have a minimum of 5 years proven 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.

Why join us?

A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.

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

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.

Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

Work Shift

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.

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.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com

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