Senior Regulatory Affairs Program Manager

2 weeks ago

London, Greater London, United Kingdom Novartis Farmacéutica Full time
Senior Global Program Regulatory Manager Job ID REQ
Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people's lives.

We are investing in new technologies and building specific therapeutic area and platform depth and capabilities – all to bring our medicines to patientseven faster.

We are seeking key talent, like you, to join us and help give people with disease and their families a brighter future to look forward to.

This role offers hybrid working, requiring 3 days per week in our London office.

As Senior Global Program Regulatory Manager, you will work with limited supervision to develop and implement the global regulatory strategy for program(s) through development, registration and post approval in the assigned region(s).

The Senior Global Program Regulatory Manager is also a member of the RA sub team and may lead or represent RA in regional or cross functional teams.

Regulatory Strategy

Provide input to global program regulatory strategy, including regulatory designations & innovative approaches and may provide global RA leadership for specific part of the program or act as lead for a program of limited complexity.

Coordinates regulatory readiness with other line functions, Country Organizations & Regions, representing RA or leads in regional RA or cross-functional activities providing strategic input into cross functional deliverables.

May lead or serve in HA meetings or local HA liaison respectively.
Regulatory Submissions

Leads planning, preparation and submission of clinic trails, and the implementation of defined global registration strategy into regional submissions worldwide with country organsiations.

Coordinates, plans and prepares for submission of initial registrations and post approval applications, and the preparation, review and maintenance of local product information as assigned.

Lead regulatory activities during HA reviews, responding to questions and HA interactions.
Regulatory Excellence & Compliance

Ensures timely RA input and submission of regulatory compliance and maintenance reports, maintaining regulatory information in compliance databases and document management systems.

Life Cycle Management
Maintenance – preparation of selected global regulatory submissions.
Portfolio Transformation – e.g. streamlining activities, divestment/ integration, portfolio transformation and manufacturing transfer.
Business & Operational Excellence – collating, for example, registration samples, CPPs etc

NB:
if the Senior Global Program Regulatory Manager acts as a Team Lead, manage several direct reports.
Science based bachelors or advanced degree, plus advance understanding of pharmaceutical development, clinical trails.

Awareness of post marketing/ brand optimization strategy, with track record of involvement in regulatory or pharmaceutical development in Phases I – IV, in multiple geographies.

Compliance and Quality mindset.
Fluency in English.

Why Novartis:
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you.

Join our Novartis Network:
Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up:
Business Unit Pharmaceuticals
Company / Legal Entity GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd.
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