Manager, Regulatory Affairs

2 months ago

Malaysia fresenius medical care Full time

Key Responsibilities / Accountabilities:

Pharmacovigilance

  • Collection of local AEs / ADRs
  • Contact point for local regulatory authorities
  • Forwarding of case reports and other important safety information to CDS
  • Following up on case reports for any missing information or upon request of CDS
  • E-mail or paper-based submission of ICSRs to authorities who do not allow electronic reporting (Non-EU countries)
  • Quarterly reconciliation of case reports
  • Screening of local literature
  • PSUR submission to local authorities
  • Local implementation of RMP commitments
  • Local implementation of safety label changes in collaboration with CDRA
  • Review of applicable local PV legislation or regulation
  • Forwarding of safety relevant Health Authority requests to CDS
  • Exchange of actions taken for safety reasons
  • Processing of local CAPA

Activity

Case management

(ICSR collection, evaluation, safety database entry, ICSR

reporting, reconciliation)

Collecting and forwarding of case reports to CDS, follow-up on local reports, non-electronic expedited reporting to local health authority (Non-EU countries), quarterly reconciliation

Management of RMPs

Local implementation of RMP commitments

Pre- and Post- marketing study Management

Participation on local non-Interventional studies and forwarding of case AE/ SAE reports to Corporate Drug Safety (CDS)

Management of Safety variations to product particulars

Local Implementation of Label changes in close collaboration with CDRA

Preparation PVAs

Inform CDS about new business partners in their territory, Preparation of local PVAs

Literature review

Screening of Local Literature

2. Regulatory Planning

a) Regulatory Plan Development

  • Plan, review and recommend the best regulatory strategy for Pharmaceutical and medical Device submissions, including regulatory timelines, during the planning phase for pipeline products of assigned portfolio based on regulatory expertise with country regulations & MOH processes.
  • Manage and ensure the country Regulatory Plans are in alignment with Product Teams & Area strategies, and the country's business plan.

b) Process Management

  • Coordinates the process with other functional members of the affiliate, sites and corporate to ensure timely availability of required documents and other requirements for dossier preparation.
  • Active participation in cross-functional teams within the affiliate and provide regulatory expertise and insight to ensure regulatory timelines are met or improved.

3. Submissions and Approvals

a) Dossier Preparation

  • Prepare a quality regulatory dossier and submit within the planned affiliate timelines for new product submissions, line extensions, variations etc.
  • Activities include: Request and obtain the various regulatory items needed for the local submission Prepare/format the dossier to ensure it meets local requirements Implement the submission and archive appropriately

b) Gain Regulatory Approval

  • Gain Malaysia MoH approvals to meet the affiliate product launch plans and ensure product maintenance.
  • Activities include: Provide quality responses to the Ministry of Health (MOH) by the due date Complete regulatory approval process and gain product licenses Communicate Product approval Archive submission dossier and approval documents Track post approval commitment, if any Perform regulatory responsibilities related packaging development Ensure the local label creation and packaging development will meet local and corporate criteria and supports the business needs

c) Metrics Review

  • Prepare periodic Regulatory Report of actual submissions and approval

4. Regulatory Compliance

a) Compliance Maintenance

  • Take appropriate actions to maintain all local marketed products in compliance with local and corporate regulatory requirements and country acts, regulations, codes, and standards or guidelines [eg. Change control for medical device, all aspects of labelling (Product Information and packaging development); label change management; chemistry and manufacturing commitments that are registered with the MoH]
  • Conduct periodic compliance self-audit to identify potential compliance issues
  • Perform activities related to pharmacovigilance (PhV) and materiovigilance according to Corporate and if applicable, by local regulations.
  • Ensure that all functions perform in accordance with the Standard Operating Procedures to meet the Good Distribution Guidelines
  • Co-ordinate the implementation and maintenance of Quality Management Systems including establishing and maintaining regulatory compliance system, coordinating management review and performing relevant audits (e.g. internal audits and vendor audits)
  • Take corrective actions plans based on regulatory and pharmacovigilance audit findings

5. Regulatory Influence

External

  • Regulatory Customer Relations Establish relationship with key regulatory officials to influence regulators to foster positive regulatory environment for business and research.
  • Regulatory Environment Changes Keep updated with current local regulations and MoH organizational structure and potential changes that will impact the business environment and communicate appropriately to involved or affected parties.
  • Influence Strategy Supports the development and implementation of the established external regulatory influence strategy.
  • Trade Association- Work with Trade Associations in Malaysia on different Regulatory issues and share company position on different topics.

Internal

a) Affiliate Organization

  • Learn and understand the local affiliate organization and functions.
  • Build functional partnership and credibility to maximize regulatory value in support of business decisions.

Requirements:

· Degree in Pharmacy and registered with the Pharmacy Board Malaysia

· Substantial experience in regulatory, quality and pharmacovigilance/materiovigilance

· Self-discipline, result driven and able to work independently

· Good command of the English Language and Bahasa Malaysia

· Strong communication and interpersonal skill

· Proven management skills

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