Regulatory Affairs Manager

About Our Client

World leader in the pharmaceutical industry, with a diverse portfolio

The Services include end to end regulatory affairs life cycle management (LCM) services for the

following countries and established products. LCM services include Health Authority

interactions, organizing translations and submission to Health Authorities.

This role is 1-2 resources. Resources should each have 3-5 years of experience.

Regulatory Frameworks and Strategy for Life cycle management.

NB. Incl all types of Variations, additional indication, renewal and MAH change. Specific to MY, change of site is NDA (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 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 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)

• Prepares pre-submission document e.g. wTOC, submission document e.g. M1 country specific incl. 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

Product Claims / Labelling

• Preparation / Update LCF and perform system compliance activities e.g. SharePoint, ShareDoc, BRAVE (replace BRAIN & CONTACT) and BASIC DCI• Check regulatory compliance of product information/artworks (Text Verification Tool)• Arranges the labelling preparation (SmPC, PIL, PI etc) by leading the regulatory required text and working with cross-functional team.• Provides regulatory information and guidance for proposed product claims/labelling.• Reviews change controls to determine the level of change and consequent submission requirements• 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.

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,

• 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

• 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

MAH withdrawal

• 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.

Regulatory Intelligence

• 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.

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

• 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

Requirements

Resources should each have 5-10 years of experience.