International Regulatory Affairs Manager (International Program Regulatory Manager)
International Regulatory Affairs Manager (International Program Regulatory Manager)
Posted on :
06-08-2025
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1 Vacancy
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Job Description
Job Description Summary
#LI-Hybrid (3 days per week on-site)Location: London (The Westworks) United Kingdom
Internal Job Title: International Program Regulatory Manager (IPRM)
Are you passionate about driving global regulatory strategies and ensuring timely execution of registration plans As an IPRM youll collaborate closely with international regulatory teams and global functions to support product registrations across diverse international markets. Youll play a key role in maintaining regulatory intelligence enhancing operational efficiency and contributing to cross-functional initiativesall while working under the guidance of the International Program Regulatory Director.
Job Description
Key responsibilities:
- Providing input into registration strategies for INT countries and drives the execution of registration plans as defined in the INT RA subteam and in partnership with the countries regional roles and global line functions as applicable including procurement of ancillary documents for submission dossier contribution to responses to Health Authority (HA) questions follow up on key milestone activities by relevant RA and line function stakeholders.
- Supporting the IPRD in partnering with DU RA roles to obtain digest and communicate efficiently pipeline information to relevant stakeholders.
- Ensures updates to registration plans are performed timely and with the necessary quality.
- Supporting the IPRD in the execution of plans for Emerging Markets Brands for assigned projects.
- Assisting the IPRD in the execution of registration plans for products that target diseases which are predominantly prevalent in INT countries.
- Partnering the IPRD in the execution of geographic expansion plans for INT countries.
- Driving the dissemination of information to and education of global roles on INT country/regional requirements.
- Advancing the implementation of functional or cross-functional initiatives particularly those with potential impacts on INT RA resources or FTE allocations.
Essential Requirements:
- Experience in Regulatory affairs in a country regional or global regulatory setting.
- Experience in regulatory license maintenance and new product registrations
- Ability to work in cross-functional environment.
- Experience in project management.
- Highly committed and team oriented.
- Ability to recognize potential regulatory issues complex situations sound risk assessment and overcoming hurdles.
- Strong team player.
Commitment to Diversity and Inclusion/EEO
Novartis is committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve.
Skills Desired
Clinical Trials Detail-Oriented Drug Development Lifesciences Negotiation Skills Regulatory ComplianceRequired Experience:
Manager
Employment Type
Full-Time
Key Skills
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