Regulatory Affairs Manager

7 days ago


Singapore Integrity Partners Pte. Ltd. Full time

Position: Regulatory Affairs Manager

Porftolio: Local Responsibilities Pharmaceuticals

THE COMPANY

At the forefront in the pharmaceutical industry, they dedicated to pioneering lifesaving therapies. Currently seeking a Regulatory Affairs Manager to lead regulatory efforts, combining technical prowess with strategic acumen.

POSITION OVERVIEW

As the Regulatory Affairs Manager, you will leverage your in-depth technical knowledge to navigate approval submissions and lifecycle management for groundbreaking pharmaceuticals.

MAIN RESPONSIBILITIES
  • Develop and implement regulatory strategies for assigned pharmaceutical products, ensuring alignment with global standards and regulations.
  • Efficiently manage the lifecycle and regional submission pipelines, maintaining adherence to time constraints.
  • Act as the primary liaison with regulatory authorities, addressing inquiries and managing communication on regulatory issues.
  • Stay abreast of evolving regulatory requirements, guidelines, and trends to inform and adapt regulatory strategy.
  • Collaborate with internal stakeholders to align regulatory strategies with business objectives.
  • Contribute to the development of the company's long-term regulatory strategy, identifying emerging trends and proposing proactive solutions.
  • Ensure compliance with ethical, legal, and regulatory standards.
  • Play a key role in maintaining the regulatory database, ensuring timely updates of regulatory information.
  • Develop plans for regulatory compliance and product labeling, providing guidance throughout the product introduction process.
  • Keep informed about changes in regulatory requirements in relevant countries.
KEY REQUIREMENTS
  • Relevant Bachelor's Degree (Bachelor's Degree in Pharmacy is an added advantage).
  • While an advantage, a pharmacy background is not mandatory for this role.
  • Minimum of 5 years in the pharmaceutical industry, with a focus on innovative pharmaceutical pipelines, particularly in oncology and rare diseases.
  • Proven track record of regulatory successes in new drug applications, especially with vaccines.

Note: Candidates demonstrating aptitude, a strong desire to learn, and adaptability may be considered, even if they don't meet all the specified requirements.

ESSENTIAL QUALITIES
  • Strong analytical skills to assess complex regulatory requirements and develop effective compliance strategies.
  • Excellent communication skills to collaborate with cross-functional teams and communicate regulatory updates at all organizational levels.
  • Detail-oriented mindset to ensure accuracy and completeness in all regulatory documentation and submissions.
HOW TO APPLY

Apply with your latest CV, detailing your relevant key achievements in regulatory affairs. We look forward to a confidential discussion about your potential role in our distinguished company.

Principal Consultant: Cheong Yee Yin

Registration Number: R22108633

EA License Number: 17C8502


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