Global Regulatory Affairs Specialist

3 weeks ago

Hyderabad, Telangana, India beBeeRegulatory Full time
Job Overview

The International Program Regulatory Manager is a key role that supports the timely execution of registration plans for assigned portfolios in international countries. This position works under the supervision of the International Program Regulatory Director and partners with international regulatory teams and global line functions to drive registration strategies.

The IPRM is accountable for recognizing and resolving high-priority topics to ensure timelines and objectives of registration plans are met. They use global, regional, and country sources to maintain relevant databases on country requirements, pipeline information, and registration plans across all international markets.

Main Responsibilities
  • Registration Strategy Execution
    • Provides input into registration strategies for international countries and drives the execution of registration plans as defined in the international RA subteam and in partnership with countries, regional roles, and global line functions as applicable.
    • Maintains up-to-date contact country contact lists for programs and countries in scope.
  • Pipeline Information Management
    • Supports 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.
  • Efficiency Initiatives
    • Supports and implements initiatives to enhance efficiency in ways of working and functional excellence.
  • Geographic Expansion Support
    • Supports the IPRD in the execution of geographic expansion plans for international countries.
  • Information Dissemination
    • Drives the dissemination of information to and education of global roles on international country/region requirements.
  • Cross-Functional Initiatives
    • Supports the implementation of functional or cross-functional initiatives, particularly those with potential impacts on international RA resources or FTE allocations.
Requirements
  • Degree in Science (e.g., Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent.
  • Minimum of 2 years in Regulatory affairs in a country, regional, or global regulatory setting.
  • Experience in regulatory license maintenance and new product registrations.
  • Ability to work in a 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.
Benefits

We offer a dynamic and supportive work environment, opportunities for professional growth and development, and a competitive compensation package.

About Us

We are a leading healthcare company dedicated to improving and extending people's lives. Our purpose is to reimagine medicine to make a meaningful difference in people's lives.

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