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Regular Lead (D level)

AlphaGen

AlphaGen

Beijing, China · Shanghai, China
Posted on Monday, November 27, 2023

The Regulatory Lead will play a pivotal role in overseeing and managing regulatory affairs activities to ensure compliance with regulatory requirements and successful product registrations. This position requires a deep understanding of regulatory processes and the ability to navigate the evolving regulatory landscape.

Key Responsibilities:

  • Develop and execute regulatory strategies to support product development and registration in alignment with business goals;
  • Prepare and submit regulatory submissions, including pre-IND, INDs, NDAs, BLAs, and other related documents, to health authorities;
  • Collaborate with cross-functional teams to ensure that products meet regulatory and quality standards;
  • Keep abreast of regulatory changes and trends, providing guidance on potential impacts on product development and registration;
  • Oversee regulatory intelligence, analysis, and reporting for regulatory compliance;
  • Ensure compliance with global regulatory requirements, including FDA, EMA, NMPA/CDE and other health authorities.

Qualifications:

  • Bachelor's degree or above in life sciences, or a related field; an advanced degree is preferred;
  • Proven experience in R&D regulatory within biotechnology and pharmaceutical industry, with a minimum of 7 years of experience in chemical drugs, experience in small molecule development in oncology or radio pharmaceuticals is a plus;
  • In-depth knowledge of NMPA/CDE, FDA and other global regulatory requirements and processes;
  • Strong strategic thinking and problem-solving skills;
  • Excellent communication and interpersonal skills.

How to Apply:

Together, we can bring breakthrough treatments to patients globally.

We are looking for highly qualified and motivated individuals who are excited to bring life-improving medicines to cancer patients.

At AlphaGen, we aim to navigate a host of multidisciplinary challenges—discover and develop compelling R&D programs; work closely with local and global partners to bring technologies into China and around the world; and bring a new class of life-changing therapies to an untapped market.

If you are a strategic thinker with a passion for radiopharmaceuticals and a desire to make a meaningful impact on healthcare, we encourage you to apply. Please submit your resume and cover letter to vivian.peng@alphagentx.com with the subject line "[Your desired position] Application - [Your Name].

AlphaGen is an equal opportunity employer.

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