International Regulatory Affairs Manager (International Program Regulatory at Novartis
London, England, United Kingdom -
Full Time


Start Date

Immediate

Expiry Date

05 Nov, 25

Salary

0.0

Posted On

06 Aug, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Risk Assessment, Regulatory Affairs

Industry

Information Technology/IT

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, you’ll collaborate closely with international regulatory teams and global functions to support product registrations across diverse international markets. You’ll play a key role in maintaining regulatory intelligence, enhancing operational efficiency, and contributing to cross-functional initiatives—all while working under the guidance of the International Program Regulatory Director.

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.
Responsibilities

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.
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