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Senior Regulatory Affairs Specialist

2 weeks ago

Klang, Selangor, Malaysia Sandoz Full time 120,000 - 180,000 per year

Job Description
Your Key Responsibilities:
Your Responsibilities Include, But Not Limited To

  • Manage regulatory submissions and liaise with Health Authorities to secure timely approvals for product launches and variations.
  • Develop and implement regulatory strategies aligned with business plans, BD&L, and launch timelines.
  • Prepare and review technical dossiers for BD&L and pipeline products within agreed timelines.
  • Ensure compliance of marketed products with local and corporate regulatory requirements.
  • Collaborate with internal teams (Quality, Patient Safety, Global Regulatory) to maintain compliance and support pharmacovigilance activities.
  • Monitor and interpret regulatory changes and communicate impacts to stakeholders.
  • Build and maintain relationships with regulatory authorities to influence positive outcomes for product approvals.
  • Support expansion into biosimilars and manage evolving regulatory challenges such as nitrosamine contamination.

Essential Requirements
What you'll bring to the role:

  • Bachelor's degree in Pharmacy, Chemistry or a related scientific discipline, with Pharmacy preferred
  • Fluent in English and Malay in both written and spoken communication
  • Minimum three years of experience in Regulatory Affairs within a pharmaceutical or generics environment, with biosimilars experience considered an advantage
  • Familiarity with regulatory requirements in Malaysia and Singapore, with prior experience handling Singapore submissions highly desirable
  • Strong understanding of registration processes, product lifecycle management and compliance with local and global regulations
  • Proactive, detail-oriented and able to work independently while influencing stakeholders effectively

Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more

With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is supported

Join us

Commitment To Diversity & Inclusion
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Sandoz