Regulatory Affairs manager ep squad apacRoche

Job Purpose
A strategic role requiring regulatory expertise and system thinking to identify and address the relevant regulatory needs and identify the connection with other business areas to successfully support the optimal use of Roche established products.
Perform Regulatory Affairs responsibilities and activities for established products at local affiliate level and above country level*
Develop regulatory strategies and manage defined regulatory activities ensuring ongoing regulatory compliance and maintenance of existing registrations throughout a product's life cycle to support continued patient access to medicines
Work closely with local affiliate and Health Authorities to support timely approvals and broadest use of products
Job Responsibilities
Strategy/Planning:
Provide regulatory expertise and input into cross-functional EP Squad/Affiliate business strategies (e.g. market access, medical affairs, promotional activities, public policy, technical assessments, technical agreements, local manufacturing/packaging activities, legal issues, etc.)
Develop innovative, risk-based registration plans and submissions strategies for established products across APAC local markets to achieve the best outcomes for patients and the business
Solicit internal and external stakeholder input, as applicable into regulatory strategies.
Represent EP Squads/Affiliate Regulatory in cross-functional teams at every opportunity and whenever it is relevant
Regular communication on updates and status reports of regulatory/registration activities
Relationship development and product specific liaison with Regulatory Authorities and local partners, where applicable, fostering open communication and healthy rapport
Gather, analyze and communicate internal and external regulatory intelligence which may affect Roche's established products portfolio
Filings:
Adapt established products' dossiers for submission based on local requirements.
Prepare and manage regulatory registration filings for defined activities across product life cycle
Maintain/updates established products licenses for technical and clinical changes/updates post-approval and other registration activities as required.
Monitor and communicate all regulatory filings status and respond to internal and external stakeholders, or other business needs.
Ensure all regulatory applications and activities occur within defined timelines according to regulatory and business requirements
Respond to regulatory questions from Health Authorities and/or internal stakeholders
Undertake issues management as needed
Ensure that complete records/files of all product dossiers and updates submitted and approved by the regulatory authorities are maintained and archived properly, including electronic submissions.
Influence internal and external stakeholders for successful regulatory outcomes.
Information and Documentation Management:
Manage and track regulatory activities using applicable Roche systems and databases
Ensure timely communication of product information updates and other regulatory updates to internal and external stakeholders in compliance with local regulatory requirements and Roche standards
Regulatory Compliance:
Work with local affiliate to develop and maintain a current knowledge of APAC and local regulations and other governing regulatory practices, policies, procedures, processes, systems and standard for established products regulatory activities conducted by the EP squad.
Ensure regulatory inspection-readiness for the EP Squad/Affiliate, as per assigned responsibilities.
Ensure regulatory compliance for products released to market according to marketing authorizations, where applicable.
Maintain product licenses validity, oversea renewals and track expiry dates as applicable
Ensure regulatory activities are consistently completed and executed in full compliance with Roche SOPs, legislative and regulatory requirements.
Other:
Oversee artwork management activities, including compliance to Local Labelling Requirements and processing pack changes on ALPIN, when required
Where applicable, review and approve promotional materials to provide regulatory input and guidance across the Affiliate, and obtain Regulatory Authorities' clearance where necessary.
Where applicable, provide regulatory administrative support for local releases.
Liaise with local partners to support local market access activities from a regulatory perspective.
Assist in any other matters pertaining to activities in RAQA department when necessary.
Any other duties that may be assign from time to time as required by the business.
SOP owner by function
Where applicable, responsible and accountable to ensure SOP is updated as per required on a timely manner.
Job Specific Competencies: -
Builds trustful and effective relationships with stakeholders.
Good practical experience of contacts with Health Authorities and local partners.
Commitment to performance measures of time, cost and quality.
Communication Skills: influence individuals or groups at more than one level who may have different interests or goals to reach consensus and achieve team objectives.
Technical Competence: possesses working knowledge of APAC regulatory environment
Takes responsibility, drives results and achieves expected outcomes.
Meticulous with an eye for details.
Knowledge
Degree in Pharmacy or other life science
Accreditation by the relevant authority with the Ministry of Health, if applicable
Eligible to hold the relevant pharmaceutical licenses for the company, if applicable
Knowledgeable in pharmaceutical regulations and registration requirements in local markets and across other markets is an advantage
Fluency in written and spoken English required and any other local languages is an advantage
Proficient in basic computer software/applications
Established Products (EP) Squad APAC is a new model that will feature a location-agnostic squad comprised of members from affiliates throughout the APAC region. They will assume responsibility for the overarching management of EP brands in participating countries. The squad will feature members across various functions such as Medical, Marketing, Strategic Alliance, Regulatory, Supply Chain and more.
The members of the EP Squad will have the opportunity to work in an exciting new cross-border roles created, providing the opportunity to take on above-market work without the need to relocate. This is a unique chance to shape a new business-operating model, and work in a self-organized squad -- fully empowered to shape the outcome. Having an EP Squad above country, allows the participating Affiliate to focus on their Strategic products portfolio as more and more products will fall into the category of Established products.
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Please attach your CV and a Cover Letter
This position is responsible for above countries (Malaysia, Philippines and Hong Kong). Those who are currently working on EP portfolio in the pilot affiliates is preferred.
Roche is an equal opportunity employer. Regulatory Affairs, Regulatory Affairs
Affiliate Regulatory Affairs
Roche

Taguig City, Metro Manila
Permanent
Full-time