Assistant Manager, Regulatory Sciences (Evergreen Position)
Core
Oversee strategy for obtaining, managing, and maintaining product Marketing Authorizations and Clinical Trial Authorizations for Oncology, Indochina, and non-vaccine portfolios across India, Indochina, and Brunei.
Role type
Assistant Manager, Regulatory Sciences
Builds
New product licenses, MA variations, MA renewals, and clinical trial authorizations for Pfizer products.
Domain
Life Sciences / Oncology / Regulatory Affairs
Required skills
Regulatory strategy development, National Regulatory Authority (NRA) engagement, submission planning, cross-functional collaboration, compliance management, stakeholder influence, database management, medical device regulatory support.
Preferred skills
Knowledge of national legislation and guidelines, trade association participation, negotiation with authorities, Good Regulatory Practice (GRP) adherence.
Technologies
Regulatory databases, document management systems, communication tools.
Responsibilities
Develop and deliver optimal regulatory strategies for assigned products and markets; coordinate pre-submission meetings and NRA engagements; manage new registration, variation, and renewal applications; respond to NRA queries; support clinical trial authorization activities; maintain regulatory databases; obtain approvals for unlicensed medicine supply; safeguard compliance in packaging and prescribing information updates; support medical device regulatory activities.
Seniority
Assistant Manager, hands-on IC