Experience Inc. Jobs

Home View All Jobs (2,186,539)

Job Information

J&J Family of Companies (Senior) Manager, Regulatory Affairs in Beijing, China

(Senior) Manager, Regulatory Affairs - 2406203122W

Description

Summary of Job Responsibilities:

  1. Responsible for the registration of Immunology TA new products/indications and marketed products.

  2. Have an in-depth knowledge of the regulatory environment and regulations and guidelines to interpret regulatory requirements and assess regulatory changes that could impact drug development and business.

  3. Closely collaborate with global, regional and local cross-functional teams to develop science-based and competitive registration strategy.

  4. Conduct life cycle management of marketed products to ensure compliance and business continuity.

  5. Deliver high-quality dossier preparation, timely submission and approval for CTA, BLA, variation and renewal.

  6. Lead HA interaction, including consultation meetings and responses to HA queries.

  7. Lead in-country QC testing to support the registration.

  8. Establish strong relationships with regulatory agencies and key local and global stakeholders.

Dimensions of Job:

  1. Support new pipeline for business growth.

  2. Regulatory support for responsible marketed products, as well as input to commercial and supply chain teams.

Principal Accountabilities of Job:

  1. Cooperate with global, regional, and local cross-functional teams to establish regulatory strategy and filing plan.

  2. Conduct life cycle management of marketed products.

  3. Interact with HA division level and above.

  4. Actively involve in the establishment and revision of regulations and guidelines.

  5. Develop internal SOPs and working instructions.

  6. Own work-related knowledge of CMC/clinical/nonclinical.

  7. Credo-based behavior in a compliance manner.

Key Performance Measures:

  1. Regulatory strategy development and execution for assigned R&D projects

  2. Timely delivery of regulatory submissions with high quality

  3. Good HA connection

Qualifications

  1. Master’s degree or above, major in chemistry, pharmaceutics, biology or a related life-science discipline.

  2. 5 years of regulatory affairs experience in a multinational pharmaceutical company.

  3. Strong lobby/negotiation capability and excellent communication skill; excellent leadership with team spirit; high learning ability and willing to work under high pressure.

  4. Have good communication with HA.

  5. Fluent English in verbal and written; good computer skill, good presentation skill.

  6. Regulatory experience in biologic CMC and Immunology TA is preferred.

Primary Location Asia Pacific-China-Beijing-Beijing

Organization J&J (China) Investments Ltd A- Beijing Branch (7075)

Job Function Regulatory Affairs

Req ID: 2406203122W

DirectEmployers