Executive recruitment company Monroe Consulting Group Philippines is recruiting on behalf of leading provider of regulatory digital compliance products and software validation & testing services for the life sciences industry. Our respected client is currently seeking a Regulatory Affairs Life Cycle Manager. This is based in Makati City but will currently be on a temporary WFH arrangement.
The successful candidate will be responsible for end to end regulatory affairs life cycle management (LCM) services for the specific countries and established products. LCM services include Health Authority interactions, organising translations and submission to Health Authorities.
Key Responsibilities:
- Regulatory Frameworks and Strategy for Life cycle management. NB. Incl all types of Variations, additional indication, renewal andMAH change. Specific to MY, change of site isNDA (Hybrid) so this is in the scope of LCM.
- Determines requirements (national, international) and options for regulatory submissions, application types and proposes plans/strategizes (if appropriate) for changes that do not require submissions.
- Predict regulatory outcomes and to recommend changes or refinements to reach the expected objective.
- Anticipates regulatory obstacles and emerging issues throughout the product life cycle and develops solutions.
- Negotiates with regulatory authorities on non-complex issues throughout the product life cycle.
- Preparation for meetings/teleconferences with HAs
- Represent RA in cross function meeting (i.e. S&OP) and provides regulatory information and guidance for proposed change.
- Primary contact for Local Health Authority on delegated LCM
- Dossier preparation and submission of hard copy paper & electronic (CD, Web-based)
- Product Claims / Labelling
- Information communication in relation to regulatory strategy and submission
- Primary RA contact and provides regulatory input & technical guidance to internal/external stakeholders, e.g. MA, CTO, GSM, Marketing, Business team, Legal team, Product Supply, PV, QA, RRAM, GRA, GRS, CMC, R2S, Brain Compliance & HA.
- Support to Global (rPTS for selected project; Regulatory Strategy; NAE; Reviews; Local Surveys; New MA ; EU-RAM)
- Clearly conveys or exchanges information, communicate external request for information with stakeholders in an appropriate and timely manner.
- Escalates and effectively communicates issues to relevant stakeholder and ensures alignment on issues, questions, and goals.
- Alignment with Headquarter functions on Variation procedure, DL e.g. CMC, Medical science, publishing Team and compilation
- Follow email notification and collaboration framework to communicate submission approval and changes impacting cross function team and upload latest approved labels (PI, Aws) on the local SharePoint for employees access.
- Translation activities
- Update / local PI (Labelling translation) NB. MY Y (RiMUP)
- Any other document for submission required to be translated.
- Advertising and Promotion
- MAH withdrawal
- Pruning
- Non-voluntary MA withdrawal
- PQSC support with or without withdrawal
- Post approval maintenance and reporting
- PV related document
- Prepare DSUR/PSUR documents, submission and perform system compliance activities e.g. BRAVE (replace BRAIN & CONTACT)
- RMP contribution / update
- Provide RA documentation and strategy support, when PVCH received requested from authority's pharmacovigilance department.
- Invoice check
- Payment to HA (arrangement from request of payment to verification/confirmation of actual INV)
- Archiving
- Regulatory Intelligence
- Cross-functional communication on Scientific Issues
- Perform RA submission as per SOP 1224 Local Supplements Document on Heath Authority interaction and perform its related BRAVE entry.
- Provide RA feedback for activities stated in SOP 1224 (RA consultation)
- Provide latest regulated information to support the following activities: medical information in case of questions from patients, customer letter issued by commercial.
- Provide RA support for documentation for tender, market access, commercial request; with legal in consultation or preserves confidentiality of product information as appropriate.
- Critical issue management
- LQSD/LSRP
- Identifies the need for new regulatory procedures and SOPs within company and participates in development and implementation.
- Assists other departments in the development of SOPs to ensure regulatory compliance.
- Helps train stakeholders on current and new regulatory requirements to ensure organisation-wide compliance
- Sunset clause monitoring
- RA representative during site inspections
- Launch
- Provide RA support in new launch including new SKU from new manufacturing site.
- Provide RA information for business case, launch application and performs relevant system updates e.g. BASIC and BRAVE
- Business compliance & Ethic
- Others: Support and response to request
Key Job Qualifications:
- Should have 3 to 5 years of experience in the said field.
- Should have end to end regulatory affairs life cycle management (LCM) services
