Senior Manager, Regulatory Affairs

2 weeks ago

Dublin, Dublin City, Ireland Regeneron Pharmaceuticals, Inc Full time

Regeneron is advancing its pipeline portfolio using a data-driven human translational approach. The In Vitro Diagnostic (IVD) Regulatory Affairs (RA)Team along with the Regulatory Affairs Global Regulatory Strategy Group (GRS) collaborate with the Precision Medicine and Clinical Sciences Teams to help develop and execute biomarker strategies across its growing clinical portfolio.

The Sr. Manager, Regulatory Affairs IVD will work closely with their RA GRS counterparts, the Companion Diagnostics (CDx) team and key cross-functional stakeholders to deliver novel in vitro diagnostics in support clinical development.

In this role, a typical day might include the following:

Contribute to the development and execution of IVD strategy in collaboration with key stakeholders and ensure that development timelines, regulatory pathways and commercialization plans are coordinated. Represent RA IVD on clinical study teams, global regulatory study teams for assigned projects to ensure chances for regulatory submissions success are maximized. Coordinate and manage reviews and revisions of regulatory submissions such as SRDs, IDEs, Performance Study Applications, 510(k)s and PMAs. Oversee Health Authorities inquiries by distributing questions and coordinating with internal personnel for timely responses. Stay abreast of changing regulations globally throughout the IVD lifecycle and develops solutions with members of RA IVD team to provide updates to the organization. Build and maintain cooperative relationships as the point of contact with IVD providers and project teams. Provide support to RA IVD department processes e.g. submission management and participates in internal RA IVD department initiative.

This role may be for you if have:

Experience authoring US Medical Device submissions (Q-sub, IDE, 510(k), PMA) Familiarity with international IVD regulations (IVDR, PMDA, etc.) and global registrational processes for medical devices/IVDs Customer focused with the ability to balance and manage multiple projects from multiple stakeholders to time and quality expectations.

To be considered for this opportunity we are looking for:

Bachelors degree in Life Sciences, Engineering or related technical field

Minimum 8-10 years' pharmaceutical or diagnostics experience including 3+ years IVD/Medical Device Regulatory Affairs experience.

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