Regulatory Affairs Manager

Roche

Petaling Jaya, Selangor
Permanent
Full-time

13 days ago

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.The PositionWe advance science so that we all have more time with the people we love.This position will be contributing positively to patients through strategic planning, execution and management of life-cycle submissions for assigned Roche products by ensuring alignment and compliance against local registration requirements as well as with company policies.Reports to Medical, Innovation and Regulatory Affairs Chapter Lead.The Opportunity:

Develop innovative, risk-based registration plans and submissions strategies across the entire product lifecycle to ensure timely regulatory filings and approvals.
Provide regulatory expertise and input into cross-functional affiliate business strategies.
Manage end-to-end local product packaging and labelling from a regulatory perspective.
Ensure regulatory compliance for product released to market and regulatory inspection- readiness for the Affiliate, as per assigned responsibilities
Responsible and accountable to ensure SOP is updated as per required on a timely manner.
Responsible as Company Pharmacist for regulatory compliance on Poison License and other pharmaceutical related regulations

Expertise:

Experience in a regulatory affairs role in a pharmaceutical environment, with a minimum of 5 years.
Degree in Pharmacy, eligible to hold the relevant pharmaceutical permits/licenses for the company. Accreditation by the relevant authority with the Ministry of Health, Malaysia
Knowledgeable in pharmaceutical regulations and registration requirements in Malaysia. Good practical experience of contacts with Health Authorities
Fluency in written and spoken English and Bahasa Malaysia. Ability to influence individuals or groups at more than one level who may
Purpose-driven, passionate to make an impact to patients and society. Strong self-organization and high achiever. Meticulous with an eye for details.
Takes responsibility, drives results and achieves expected outcomes.

Good project management and multi-tasking abilitiesWho we areAt Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.Roche is an Equal Opportunity Employer.

Roche

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