Category

Description

People Management/Leadership:
Where applicable, recruit, on-board, train, develop and retain talent on the Affiliate Regulatory Affairs team
Oversee and manage all Regulatory Affairs work of the Affiliate
As applicable, oversee external parties, such as distributors, agents, etc.
Ensure appropriate Regulatory Affairs resources and budget are in place

Strategy/Planning:
Shape the regulatory environment by participating in industry associations on regulatory policy and regulations; taking regulatory convergence into consideration
Contribute to and influence global regulatory strategies, considering local regulation and business needs
Own regulatory intelligence gathering and dissemination across the Affiliate; involving regional and global organisations, when appropriate
Lead Regulatory Affairs input into cross-functional Affiliate business strategies (e.g. market access, medical affairs, promotional activities, public policy, technical assessments, technical agreements, local manufacturing/packaging activities, legal issues, etc.)
Lead and develop risk-based regulatory strategies and work plans for all products across the Affiliate to accelerate access in alignment with global

Filings:
Ensure timely execution of all regulatory filing activities across product lifecycles, including performing some or all of the work of DRA staff
Lead contact and negotiation with local HAs and internal stakeholders to build and cultivate trusted partnerships
Ensure regulatory filings are aligned with commercial and supply needs to assure business continuity
Influence internal and external stakeholders for successful regulatory outcomes

Regulatory Compliance:
Develop and maintain current knowledge of international and local regulations and other governing regulatory practices, policies, procedures, processes, systems and standards
Ensure regulatory inspection-readiness for the Affiliate, including leading or participating in internal/external regulatory audits
Ensure all Affiliate regulatory activities comply with Roche global standards and local regulations
Ensure regulatory compliance for product released to market according to marketing authorisations
Ensure accurate, timely and thorough data entry for Affiliate regulatory activities on relevant Roche systems

Other:
Manage end-to-end local product packaging and labeling from a regulatory perspective
Where applicable, provide review and approvals of promotional materials to ensure appropriate regulatory input for the Affiliate
As applicable, manage shipment clearance/QA release of Affiliate materials/products
Support local market access activities from a regulatory perspective

Education / Qualifications:
Degree in Pharmacy
Accreditation by the relevant authority with the Ministry of Health, Malaysia
Eligible to hold the relevant pharmaceutical licenses for the company

Experience
Experience in a regulatory affairs role in a pharmaceutical environment, preferably of 5 -7 years.

Knowledge
Knowledgeable in pharmaceutical regulations and registration requirements in Malaysia
Fluency in written and spoken English and Bahasa Malaysia
Proficient in basic computer software/applications

Job Specific Competencies
Builds trustful and effective relationships with stakeholders
Good practical experience of contacts with Health Authorities
Commitment to performance measures of time, cos

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