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Regulatory Affairs Manager / Senior Manager

Date: Feb 12, 2019

Location: Bangkok, TH, 10110

Company: Teva Pharmaceuticals

Company Info

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!

Job Description

Key Responsibilities

  • Act as a single point of contact for technical expertise in local laws, regulations, regulatory requirements and other regulatory related guidance in Research and Development and product registration of generic, new generic and new drugs in Thailand.
  • Ability to interpret regulations, technical guidelines, policies from the local Health Authority, translate into regulatory strategy, bringing innovative solutions and apply successfully in new MA applications and MA maintenance work.
  • Work closely with COREx and other cross-functional team to compile complete registration documents for faster product registration submission and approval in Thailand.
  • Prepare, monitor and identify issues early in the submission preparation process, assess the acceptability of submission, respond to regulatory authorities and update to internal stakeholders.
  • Provide regulatory input throughout the product life cycle, anticipate regulatory obstacles, propose strategies, monitor emerging issues and identify solutions and are involved in business/organization activities, management and strategy.
  • Negotiate and interact with regulatory authorities during the development and review process to ensure product registration submission and approval.
  • Provide guidance and coaching to develop local RA team members
  • Overview of submission compilation up to approval and launch

Knowledge, Skills and Abilities

  • Have strong technical and management skills and actively engage in regulatory strategy and operations.
  • Have regulatory knowledge throughout the product life cycle with aspects of effective management and strategy development.
  • Able to demonstrate skills and knowledge in areas such as, but not limited to: strategy development, risk assessment and management; monitoring and communicating regulatory and related changes.
  • Strongly and effectively communicating with international/multinational RA and relevant team such as quality, supply chain, procurement, etc.
  • Serves as a resource for best practices/quality on functional teams or project
  • Able to be a mentor for junior staff in technical skills including regulatory, product quality, pharmacovigilance perspectives.
  • Interprets internal or external business issues and recommends solutions/best practices
  • Able to work and leverage the strengths of cross-functional team.
  • Skilled at leading and managing people or projects

Qualifications

  • Minimum Bachelor’s Degree in Pharmacy / Pharmaceutical Science
  • 5-10+ years’ experience with new generic and new drugs registration in Multi-national companies in Pharmaceuticals
  • Excellent communication in English in both verbal and written
  • Strong knowledge of Thailand regulatory authorities, laws, regulation, generic/new generic/new drug registration requirements and guidelines
  • R&D and QA knowledge & experience as an asset
  • Good interpersonal skills
  • Good leadership skills
  • Good mentor skills
  • Good negotiation skills

Function

Regulatory Affairs

Sub Function

Medical Regulatory Affairs

Reports To

Director

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.