Regulatory Affairs Specialist

17 hours ago

Subang Jaya, Selangor, Malaysia F. Hoffmann-La Roche Gruppe Full time

At F. Hoffmann-La Roche Gruppe, we're pushing back the frontiers of healthcare by harnessing innovation, curiosity, and diversity. With over 100,000 people across 100 countries, our success is built on a passion for exceptional care.

The Position

Job Purpose

  • To carry out Pharmaceutical affairs responsibilities and activities for assigned products and tasks.
  • Responsible as Company Pharmacist if required.
  • Required to collaborate with both internal and external cross-functional team members, as well as with external stakeholders.
  • All employees are expected to practice high standards of compliance with both external and internal policies and regulations as well as participate and be involved in SHE initiatives within the Company.

Responsibilities and Accountabilities

Strategy/Planning:

  • Gather, analyse and communicate internal and external regulatory intelligence.
  • Provide regulatory expertise and input into cross-functional 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 products.
  • Represent Affiliate Regulatory in cross-functional teams if delegated by Regulatory Affairs Lead.
  • Provide updates and monthly status reports on regulatory/registration activities.
  • Liaise closely with Health Authorities and Professional Bodies and foster good rapport with them.

Filings:

  • Prepare and manage regulatory registration filings across product life cycles registration of new products and new indications (including Line Extensions & New Molecular Entities from R&D pipeline).
  • Life-cycle maintenance/updating of registered products for any changes/updates post-approval commitments other registration activities as required.
  • Monitor and communicate all regulatory filings status and respond to internal and external stakeholders, or other business needs.
  • Ensure timely regulatory filings submissions and approvals.
  • Ensure that complete records/files of all product dossiers and updates submitted and approved by the regulatory authorities are maintained and archived properly, including on-line submissions.
  • Influence internal and external stakeholders for successful regulatory outcomes.

Information and Documentation Management:

  • Manage Pharmaceutical activities on relevant systems.
  • Manage product information updates with respect to company and local regulatory requirements and for databases.

Regulatory Compliance:

  • Develop and maintain a current knowledge of international and local regulations and other governing regulatory practices, policies, procedures, processes, systems and standards.
  • Ensure regulatory inspection-readiness for the affiliate, as per assigned responsibilities.
  • Ensure regulatory compliance for product released to market according to marketing authorisations.
  • Manage the Import License and associated Product List with timely updates for additions/changes.

Other:

  • Support local market access activities from a regulatory perspective.
  • Responsible as Company Pharmacist for regulatory compliance on Poison License, Psychotropic importation and other pharmaceutical related regulations.
  • Assist in any other matters pertaining to activities in RAQA department when necessary.
  • Any other duties that may be assigned from time to time as required by the business.
  • Clearance from Regulatory Affairs Lead is required for all matters related to regulatory affairs, except routine ongoing activities; these include the following:

Competencies

Job Specific Competencies:

  • Builds trustful and effective relationships with stakeholders.
  • Good practical experience of contacts with Health Authorities.
  • Dedication 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 regulatory environment.
  • Takes responsibility, drives results and achieves expected outcomes.
  • Meticulous with an eye for details.

Who You Are

  • Experience in a regulatory affairs role in a pharmaceutical environment, with a minimum of 2 years.
  • Degree in Pharmacy.
  • Accreditation by the relevant authority with the Ministry of Health, Malaysia.
  • Eligible to hold the relevant pharmaceutical licenses for the company.
  • Knowledgeable in pharmaceutical regulations and registration requirements in Malaysia.
  • Fluency in written and spoken English and Bahasa Malaysia.
  • Proficient in basic computer software/applications.
Our Team

We're a global community of innovators, united by a shared passion for healthcare and a commitment to making a difference. At Roche, every voice matters and we believe that inclusion is key to understanding people's varied healthcare needs.

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