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Regulatory Affairs Life Cycle Manager

Job Category:

Others

Job Level:

Professional

Open Date:

19-Nov-2021

Location:

CITY OF MAKATI

Close date:

31-Dec-2021

Client Industry:

HOSPITALS/HEALTHCARE

Job Description and Qualification:

Job Description

  • Handle end to end regulatory affairs life cycle management (LCM) services for various countries and established products, including Health Authority interactions, organizing translations and submission to Health Authorities
  • 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 lifecycle and develops solutions
  • Negotiates with regulatory authorities on non-complex issues throughout the product lifecycle
  • Preparation for meetings/teleconferences (e.g. presentation contribution) with Health Authority
  • Represent RA in cross function meeting and provides regulatory information and guidance for proposed change
  • Primary contact for Local Health Authority on delegated LCM
  • Prepares pre-submission documents e.g. wTOC, submission document e.g. M1 country specific including Patent declaration, QP declaration, GMP cert and submits electronic (eCTD, ACTD) and paper regulatory submissions according to applicable regulatory requirements and guidelines
  • Request BEC and perform system activities e.g. SharePoint, ShareDoc, BRAVE (replace BRAIN & CONTACT) and BASIC CA
  • Ensure access to local electronic systems e.g. various HA systems access by applicant, local RA data bases, country mailboxes and group email
  • Submits notifiable changes and supplemental dossiers to the appropriate regulatory authorities to update product information and/or instructions for use to reflect current state of product knowledge
  • Reviews change controls to determine the level of change and consequent submission requirements
  • Provides regulatory information and guidance for proposed product claims/labelling
  • Arranges the labelling preparation (SmPC, PIL, PI etc) by leading the regulatory required text and working with cross-functional team
  • Check regulatory compliance of product information/artworks (Text Verification Tool)
  • Preparation / Update LCF and perform system compliance activities  e.g. SharePoint, ShareDoc, BRAVE (replace BRAIN & CONTACT) and  BASIC DCI
  • 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
  • Update / local PI (Labelling translation) NB. MY Y (RiMUP)
  • Any other document for submission required to be translated
  • Review advertising / promotional material against approved label (where applicable)
  • Reviews and approves advertising and promotion to ensure regulatory compliance. NB. MYSG Promat review delegated to MA
  • Perform system compliance activities to support Global/Local Pruning
  • Non-voluntary MA withdrawal: Participates in implementation of regulatory strategy and processes for handling recalls and communication to stakeholders (e.g., Dear Healthcare Professional letters, patient letters, distributor letters, and health authorities)
  • PQSC support with or without withdrawal: Reports product safety issues to regulatory authorities as required, to comply with local, regional and global regulations
  • Develops and implements LCM processes involved with maintaining licenses, registrations, and renewal
  • Assures post market regulatory requirements are met (e.g., required reports, supplemental submissions, and other post marketing commitments)
  • Perform post approval activities including system updates and CFT communication
  • 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
  • Payment to HA (arrangement from request of payment to verification/confirmation of actual INV)
  • Archiving submission dossier in archiving system as per local archiving requirements e.g. ShareDoc etc.
  • For labelling archive to follow latest updates on this e.g. ShareDoc or Linchpin or local shared drive
  • Management of local RA requirements and update base wTOC at APAC SharePoint
  • Understands the impact of changing regulations on preapproval and post-approval strategies and approaches and advises internal stakeholders on a course of action
  • To communicate regulatory Intelligence, strategic activities, consultation via the APAC RPI process e.g. email communication template, summary template, update CATweb and RAPID
  • 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
  • Understands the issue and provides guidance to integrate regulatory considerations to support issue management
  • Participates in risk-based decisions on special access approvals/compassionate use based upon patient needs and risk assessment. Provide RA support to secure special consignment, import permit, NPP, EAP
  • Participates in and provide RA support in S&OP (if necessary or provide information for the meeting, management of out of stock situations and Product Quality and Safety Committee (PQSC)
  • Perform RA submission to HA following local ACF manager or local Crisis team decision as per Margo No. 50 and local SOPs
  • 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 organization-wide compliance.
  • Sunset clause monitoring
  • RA representative during site inspections
  • 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
  • Abides by and upholds the laws and regulations of the authorities under which he or she operates and the organization’s internal/external policies and directives
  • Takes all possible steps to prevent and resolve any real, apparent or potential conflicts of interest between work responsibilities and private affairs
  • Ensure regulatory aspects of business relationships to ensure compliance and protect Bayer corporate interests
  • Performs regulatory due diligence and identifies risks and opportunities for executive management (such as M&A, license acquisition, franchise), if any
  • Dependent countries e.g. dossier, certifications, reply to BRAIN/BRAVE compliance etc.
  • Regional and or Global questionnaires, survey etc related to product/TA/project incharge

 


Qualifications

  • Must have 3-5 years of experience or more in Regulatory Affairs Life Cycle Management in Pharma, Health and Life Sciences industry
  • Must have Bachelors Degree
  • Amenable to work from home on a shifting work schedule (may be nightshift or midshaft)


Salary:

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