Senior Manager, Global Regulatory Affairs, Precision Medicine

Gilead

Cambridge, United Kingdom

As an Senior Manager, Global Regulatory Affairs, Precision Medicine, you will help develop and execute Precision Medicine regulatory strategy in alignment with the drug global regulatory strategy and in compliance with the appropriate IVD regulations. You will need to work closely under the direction of the Precision Medicine Leadership, collaborate with the Biomarker diagnostics team and global/regional Regulatory liaisons, to support Precision Medicine global regulatory initiatives and offer guidance, as applicable. You will provide fit-for-purpose operational and technical diagnostics (Dx) regulatory assistance through all stages of drug clinical programs, global registration, and market access.

Responsibilities:

Represent Regulatory Affairs Precision Medicine or Dx Regulatory in cross-functional teams involved in the application of biomarkers and IVDs in drug clinical programs;
Support implementation of business aligned Precision Medicine regulatory strategies to support Gilead assets from early development through registration and beyond;
Maintain current understanding of changing global IVD and Companion Diagnostics (CDx) regulations, assess impact on drug development & registration activities;
Provide Dx regulatory input to ensure compliance of diagnostics used in therapeutic trials with global and local regulatory requirements (such as US FDA and EU IVDR);
Support preparation and filing of IVD Performance Study applications, SRD & IDE applications, HA briefing books, clinical protocols, study reports, ICFs, Investigator Brochures, IND applications, CTAs, BLAs, NDAs, PMAs, and labeling documents for drug and diagnostic products, in collaboration with Gilead internal functions, IVD partners and CROs;
Contributes to Dx Regulatory QMS process improvements related to investigational devices which may have a significant impact on business;
Support training related to the IVD/CDx medical devices & broader Precision Medicine initiatives;
Ensures compliance with established practices, policies, pro cesses, and any applicable regulatory requirements.

Basic Qualifications:

Bachelor's Degree and extensive experience; OR
Masters' Degree and extensive experience.

Preferred Qualifications:

PharmD/MS with relevant experience;
BA/BS with relevant experience;
Significant Regulatory, Quality, compliance or related experience supporting development of investigational IVD devices in a biopharma setting;
Experience with immuno- and molecular diagnostics technologies;
Experience leading cross-functional diagnostics teams;
Experience with authoring procedures and implementing processes;
Experience working in companion diagnostics projects is strongly preferred;
Experience with global policy, IVD regulations (e.g., EU IVDR, 21 CFR Parts 820, 814, 812, 809, FDA’s LDT Rule, CLIA), standards (e.g. ISO 13485, ISO 20916, ISO 15189) and applicable guidelines (e.g., MDCG, EMA, FDA, etc.) as these apply to diagnostic development and authorization/clearance/approval;
In-depth knowledge of applicable IVD regulatory requirements, international standards and guidance in the context of drug clinical development - ensure compliance with IVDR, adherence to GCP, and alignment with Medical Device QMS operations;
In-depth knowledge of relevant Health Authorities (HA), as evidenced by past effectiveness and success with HA interactions;
In-depth knowledge of the CDx co-development process, including key functions involved at various stages of development;
Strong analytical skills, attention-to-detail, and writing skills, as evidenced through accomplishments in past roles;
Strong interpersonal and communication skills, with ability to rapidly understand and adapt to different team dynamics;
Proven ability and flexibility to work successfully in a team-oriented, matrixed environment;
Strong organizational and project management skills (familiarity with MS Office Suite, SharePoint, Smartsheet, Lucid chart and other PM tools);
Ability to travel, as needed.