Sr. Director, Regulatory Affairs

**Job Description Summary**:
**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

**Our vision for Pharmaceutical Systems at BD**

With innovative pre-fillable syringes, self-injection systems, safety systems and needle technologies, the Pharmaceutical Systems (PS) team offer an extensive selection of solutions designed to protect, package and deliver drug therapies.

**About the role**

Reporting to the Vice President, Regulatory Affairs, the Sr. Director Regulatory Affairs is responsible for leading the Pharmaceutical Systems (PS) Regulatory teams located in France and the United States.

In this role, you will own regulatory activities for the entire Pharmaceutical Systems product portfolio mostly related to combination products (pre-fillable syringes, safety systems, pens, autoinjector and wearable injectors).

You will lead the team in charge of interfacing with customers to ensure successful market launch of their final drug device combination products. This position works closely with R&D and Medical Affairs to frame regulatory strategy and objectives for new product developments in alignment with Pharmaceutical Systems business needs.

**Main responsibilities will include**:

- Own the regulatory strategy to ensure all PS products meet the latest regulatory requirements and customer needs.
- Set up the necessary tools and processes to ensure the RA team works collaboratively. Support the team in the implementation of their objectives, with constant concern for their well-being.
- Responsible for the development of the organization, career ladder for RA associates and the identification of required skills, resources, and abilities to achieve business objectives.
- Own promotional material review activities and business specific procedures if relevant. Accountable for alignment of PS external communication & claims to regulatory requirements.
- Educate/Train the PS cross-functional teams on EU and FDA requirements applicable both to Pharmaceutical systems and our customers, on an ongoing basis, to ensure current and future associates understand the regulatory framework and environment.
- Accountable for the appropriate registrations with the Competent Authorities as well as regular updates when required.
- This role will work closely with the PS LT team to:
1) Ensure new product developments are set for success.

2) Create engagement strategies to connect with customers.

3)Develop response strategies for regulatory questions and prepare team for interacting and negotiating with regulatory agencies if necessary.

4) Engage in compliance related activities (including field action committee engagement)

**About you**:
For this role we seek a strong Regulatory Affairs leader with experience within the Medical Device industry, and ideally within drug device combination products.

Also you will have:

- Pharmacist or Scientist or University degree in Life Sciences. B.S. or B.A. degree in a technical discipline (e.g., engineering, biology, chemistry). Advanced degree preferred; medical training preferred.
- Ability to navigate in a matrix environment. Able to build solid foundations with team members so that RA is a business partner in all needed aspects and has a strong and respected voice.
- Demonstrated project management, negotiation, and communication (written and oral) skills.
- Comprehensive knowledge of U.S. medical device regulations, Good Clinical Practice standards, Good Laboratory Practice regulations, and Quality System Regulation.

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,