Pharmaceutical Compliance Manager

14 hours ago

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

F. Hoffmann-La Roche Gruppe is a leader in the research-focused healthcare group, committed to harnessing innovation and curiosity to push the boundaries of healthcare. Our team of over 100,000 people worldwide share a common goal - to provide exceptional care to those in need.

The Position

Job Purpose

  • To execute 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 adhere to 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

Strategic Planning:

  • Capture, analyze and disseminate internal and external regulatory insights.
  • Offer 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 forward-thinking, risk-based registration plans and submissions strategies for products.
  • Represent Affiliate Regulatory in cross-functional teams if delegated by Regulatory Affairs Lead.
  • Provide periodic and monthly status updates on regulatory/registration activities.
  • Nurture strong relationships with Health Authorities and Professional Bodies and establish a positive rapport with them.

Filings and Submissions:

  • Prep 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).
  • Maintenance and updating of registered products for any changes/updates post-approval commitments other registration activities as required.
  • Monitor and inform all regulatory filings status and respond to internal and external stakeholders, or other business needs.
  • E nsure timely regulatory filings submissions and approvals.
  • E nsure 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.
  • Affect internal and external stakeholders for successful regulatory outcomes.

Information and Documentation Management:

  • Oversee Pharmaceutical activities on relevant systems.
  • Update product information respecting company and local regulatory requirements and for databases.

Regulatory Compliance:

  • Keep abreast of international and local regulations and other governing regulatory practices, policies, procedures, processes, systems and standards.
  • E nsure regulatory inspection-readiness for the affiliate, as per assigned responsibilities.
  • E nsure regulatory compliance for product released to market according to marketing authorisations.
  • Manages the Import License and associated Product List with timely updates for additions/changes.

Other:

  • Support local market access activities from a regulatory viewpoint.
  • 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:

  • Establishes trustful and effective relationships with stakeholders.
  • 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 We Seek

  • 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.
About Us

Roche is a pioneer in the field of healthcare, dedicated to making a meaningful impact through cutting-edge innovations and compassion.

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