Regulatory Project Manager
Regulatory Project Manager
About the Opportunity
The Regulatory Product Manager will be responsible for managing regulatory activities and EU strategy for a marketed product with an active Life Cycle Management, within Immunology and Inflammation, at Global Regulatory Affairs, Region Europe (GRA-EU) : Dupixent (dupilumab).
She/he will work under the responsibility of the Product Regulatory Lead (as part as a Dupixent regulatory managers team) and will cover the maternity leave of one of the Product regulatory managers.
- Coordinate the preparation and contribute to writing and review of regulatory documentation in collaboration with key internal stakeholders (nonclinical, clinical, medical, pharmacovigilance functions, etc.)
In particular, coordinate the preparation and the submission of paediatric investigation plans (PIP) for new indications (eg. CRSsNP).
- Coordinate preparation of Clinical Trial Applications (CTAs) or amendment to CTAs, or of response to questions from HAs on CTAs, for specific indications under investigations (eg. CRSsNP, PN) or for ongoing phase 4 studies (eg. Atopic Dermatitis sleep study).
Represent Global Regulatory Affairs at the corresponding Clinical Trial Team meetings.
- Initiate and coordinate the preparation of the Product Marketing Authorization first renewal. Lead the kick-off meeting for this procedure.
- Ensure maintenance and compliance of regulatory activities (like DSURs, PSURs; PIP annual update Atopic Dermatitis and Asthma), including archiving and tracking in databases and systems.
- Provide operational support to the other Product Regulatory Managers in any major regulatory submissions (eg. Scientific advice request or type II variations) that would have to be prioritized during the period.
- Contribute to the execution of the Region Europe agency relations management strategy.
- Follow regulatory intelligence updates and competitor's status and assess potential impact on daily activities and project strategy, including sharing with the appropriate stakeholders within the department or project team(s).
Education and previous experience
- Master's degree in a Life Sciences subject, e.g. Physician, Pharmacist, Veterinarian or other Life Sciences Degree;
- Minimum of 2 years of relevant work experience in EU Regulatory Affairs,
- Good knowledge and operational expertise of EU regulations, and ability to implement this into regulatory strategy and practice;
- Development and business environment understanding;
- Excellent scientific writing and presentation skills;
- Previous experience in the field of biologicals / rare diseases;
- Ability to produce written and oral regulatory or scientific communications with clarity and accuracy; ability to communicate effectively and efficiently with other functions in the business, as well as with the Health Authorities;
- Ability and flexibility to work with multifunctional and multicultural teams with strong understanding of organizational and inter-cultural sensitivities;
- Sense of responsibility, urgency and reporting;
- Team worker
- Fluent English in writing and verbally;
- Affinity for systems and technology.
Are you interested please send an updated CV or give me a call 0205221588