Job Description Summary

Reporting to the Sr. Director of Regulatory Affairs, the RA Senior Manager for the Pre-fillable Syringes Platform is responsible for leading the RA team members involved in pre-fillable syringes new product development projects. The position is based in Le Pont de Claix.

In this role, you will oversee regulatory activities for the PFS new product portfolio, primarily focusing on assessing, understanding, and cross-functionally building the deployment and impact of standards related to new product design. You will serve as the RA representative on the PFS platform and work closely with other RA teams to interface with the PFS platform.

You will lead the team in charge of cross-functional collaboration through the project team, ensuring RA support throughout product development, including design control and project milestones. Additionally, you will participate in the project as the RA representative when needed. This position works closely with R&D, Quality Engineering, and Medical Affairs to frame regulatory strategy and objectives for new product developments in alignment with Pharmaceutical Systems' business needs.

Job Description

About the role

Reporting to the Sr. Director of Regulatory Affairs, the RA Senior Manager for the Pre-fillable Syringes Platform is responsible for leading the RA team members involved in pre-fillable syringes new product development projects. The position is based in Le Pont de Claix.

In this role, you will coordinate regulatory activities for the PFS new product portfolio, primarily focusing on assessing, understanding, and cross-functionally building the deployment and impact of standards related to new product design. You will serve as the RA representative on the PFS platform and work closely with other RA teams to collaborate with the PFS platform.

You will lead the team in charge of cross-functional collaboration through the project team, ensuring RA support throughout product development, including design control and project achievements. Additionally, you will participate in the project as the RA representative when needed. This position works closely with R&D, Quality Engineering, and Medical Affairs to frame regulatory strategy and objectives for new product developments in alignment with Pharmaceutical Systems' business needs.

Your main responsibilities will include:

• Lead the team ensuring the right balance between support and empowerment as well as the right level of development and coaching to support cultural change and position the one RA team as solution-oriented team.
• Be responsible for the regulatory strategy to ensure all PS products meet the latest regulatory requirements and customer needs and to ensure new product developments are set for success.
• 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. Develop response strategies for regulatory questions and prepare team for interacting and negotiating with regulatory agencies if vital.

About you:

For this role, we are seeking a leader with experience in regulatory affairs and R&D within the pharmaceutical and medical device industries, ideally with expertise in drug-device combination products.

The successful candidate will be an inspirational leader, with experience in regulatory and/or R&D, quality engineering functions, strong knowledge in design control and product development, and a consistent track record in regulatory standards, submission dossier preparation and interactions with regulatory authorities.

Also you will have:

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

Click on apply if this sounds like you!

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Required Skills

Optional Skills

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Primary Work Location

FRA Le Pont-de-Claix Cedex

Additional Locations

Work Shift

At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.

Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. 

The salary or hourly rate offered to a successful candidate is determined by their experience, education, and skills, as well as the labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location.

Salary Range Information

80 700,00 € - 145 300,00 € EUR Annual