Regulatory Affairs and Quality Assurance Manager

4 days ago

Singapore beBeeRegulatory Full time $90,000 - $120,000
Job Title

We are seeking a professional to oversee regulatory affairs, pharmacovigilance, and quality management control.

About the Role

The ideal candidate will have experience in managing client relationships, developing regulatory strategies, and ensuring compliance with local regulations.

Responsibilities
  • Develop and maintain client relationships and explore opportunities for increased service support.
  • Participate in regulatory processes to gain and maintain marketing authorizations for human and veterinary medicinal products.
  • Prepare, review and compile documents within regulatory affairs projects.
  • Communicate with clients and health authorities; provide scientific advice procedures and represent clients with health authorities.
  • Plan and execute client projects in line with KPIs; coordinate project teams with colleagues and external partners.
  • Provide general consultancy on Regulatory Strategy and Procedure Management.
  • Maintain regulatory intelligence and share knowledge with colleagues.
  • P present seminars and contribute expertise to colleagues, clients and professional audiences.
  • Support Value Delivery Centre strategy implementation and optimization.
  • Ensure compliance and contribute to optimizing internal processes.
  • Support commercial, marketing and business development activities including proposal input; assist in budgeting and reporting.
  • Provide on-site regulatory support to Global Consulting Services clients as agreed with the Head of Value Delivery Centre Regulatory.
Requirements
  • Proven experience or demonstrable capability in the area of responsibility or similar field.
  • Ability to implement tactical goals of customer or internal projects; prioritize parallel tasks and identify road blocks.
  • Structured, analytical, independent working style with sound judgment on operating policies.
  • Strong problem-solving and pragmatic solution development; high service orientation.
  • Ability to train and support junior colleagues; capable of leading small projects.
  • Skill in managing internal and external relationships at operational and senior levels.
  • Good written and verbal communication; effective presentation skills.
  • English business fluent and local language proficiency as appropriate.
What We Offer

Benefit offerings outside the US may vary by country and will be aligned to local market practice.

Equal Employment Opportunity

We are committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

Seniority level
  • Mid-Senior level
Employment type
  • Full-time
Job function
  • Quality Assurance
Industries
  • Pharmaceutical Manufacturing

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