Job description:

A full time position responsible for  regulatory and commercial quality activities for the company's products (including   brand, generic & cosmetic products) in Hong Kong & Macau.
- Ensure that all new products are   registered according to local regulations and company policy in a defined   timeline.
- Maintain the local registrations through   timely renewal and life cycle management & ensure products introduced in   the local market are in compliance to local regulations and company guidelines.
- Implement Quality Management System (QMS)   and the related GxP activities accordingly
- Provide regulatory & quality support   for commercial activities.

Specific Responsibilities:
New   product registration / Local registration maintenance & life cycle   management:
• Communication with global team   for local requirement and documents required for regulatory submissions.
• Review and compile submission   package to local health authorities & handle queries, if any
• Interact with health authorities   to ensure approval can be granted in a defined timeline and obtain up-to-date   intelligence
• Communicate with internal   stakeholders (i.e. local Commercial, site RA, CoREx and Portfolio team) on   the submission status.

• Review and update safety information in accordance with local        regulatory requirements and timeline, if needed.
• Review and approve packaging artworks for submission/production
• Preparation of materials for Secondary Repackaging.

Commercial   Quality Affairs:
• Roll out and execution of Quality Management System (QMS)
o Create,   maintain up-to-date and distribute Standard Operating Procedures and Working   Instructions as per Teva standard and in compliance with national   regulations.
o Ensure   GMP & GDP compliance at the commercial unit and promote the quality   culture.
• Support routine QA operations   (including but not limited to market release, complaints and recalls, change   controls, etc.)
o Ensure   that quality complaints are registered and liaise with manufacturing site to   trigger corresponding investigation and adequate corrective actions. Where   necessary, liaise with pharmacovigilance department.
• Authority inspections &   audits
o Host   and lead GMP/GDP related competent authority inspections
o Perform   or coordinate internal audits of the compliance of the Quality System.
o Coordinate   with the Corporate audit team, with respect to quality related matters, of   local warehouses/distributors and other suppliers/service providers as per   Teva standards.
Others:
• Support  commercial activities by providing registration information to tender   submission & drug enlistment.
• Be a deputy person-in-charge of   the wholesale dealer's license in Hong Kong and coordinate the relevant activities   with local health authority
• Ensure that processes are   clearly defined in SOPs and being executed
• Ensure the trainings and   application of SOP/WIs are done on a timely manner
• Ensure internal systems are   being updated to reflect the current status
• Maintain and archive all   records according to GDP practice and company guideline
• Collaboration with cross-function teams   & provide regular update to the management team
• Establish trustful   relationships with external stakeholders
• Assist in ad-hoc duties as   requested by the manager

Required profile:

• Basic Degree in Life Sciences   specialties, eg. Pharmacy, Medicine, Biological Sciences
• Preferably 2 or more years of   regulatory and quality experience in the pharmaceutical and regulated   industry
• Demonstrated knowledge and   experience in pharmaceutical import & distribution operations with PIC/S   GMP and GDP and local regulations and industry practices,
• Experience in handling regulatory   submissions (i.e. new applications and variations) to the local authority
• Basic knowledge in drug   development and pharmacovigilance
• A good balance of Regulatory, Quality and   Business acumen
• Solid knowledge and understanding of local   drug / healthcare regulations and ability to apply them at work effectively
• Good communication & interpersonal   skills, fluent in written and spoken English and Chinese, as   to clearly communicate with all levels in the organization and external   stakeholders
• Flexibility to work in a   cross-cultural diverse environment
• Strong negotiation and persuasive skills
• Able to work under pressure and to tight   timelines
• Effective time and priority management
• Independent, self-motivated, as well as a good   team player
• Attention to details and logical analytical   skills
• Proficient computer skills including MS   Office

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!