Lead lifecycle maintenance activities for marketed products across TAs
Develop regulatory strategy plans to support successful LCM of marketed products including line extensions and variations, and provide Regulatory expertise to local product and cross-functional teams
Ensure timely Regulatory filings and response to HA queries for marketed products
Provide mentoring and coaching to junior staff members
Establish strong relationship with regulatory authority and key stakeholders in the local, regional and global organization
Principal Accountabilities Of Job
Collaborate with global, regional and local product teams to develop and implement registration plan and strategy.
Oversees regulatory activities & review critical submissions for marketed products.
Interact with HA review divisions.
Lead team response efforts to HA request.
Lead revision of regulations, guidelines if applicable.
Develop internal regulatory process for effective operation.
Credo based behavior with regulatory compliance excellence.
Qualifications
Bachelor’s or above degree in chemistry, pharmaceutics, biology or a related life-science discipline. Advanced degree is preferred.
Minimum of 10 years regulatory affair experience including 5 years in managerial role in a multinational pharmaceutical company.
Strong oral & written communication skill; excellent leadership capability and ability to work under pressure. Demonstrated ability to effectively manage and lead a team.
In-depth knowledge of regulatory environment, regulations and guidelines. Experience in HA interactions and pharmaceutical product registration.
Ability to communicate regulatory plan and strategy to local teams. Experience in working in project teams and/or a matrix organization.
Proficiency in verbal and written English; good computer skill, good presentation skill.
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