Associate Director/Senior Manager, Regulatory Affairs China-Immunology

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Regulatory Affairs Group

Job Sub Function:
Regulatory Affairs

Job Category:
Professional

All Job Posting Locations:
Beijing, China

Job Description:

Associate Director/Senior manager, Regulatory affair China, Immunology TA

  Summary of Job Responsibilities


* Develop and implement regulatory strategies for new Immunology products and life-cycle management , aligning with business objectives.


* Serve as the Regulatory Lead to provide regulatory input to China and global compound teams..


* Act as the RA representative to offer regulatory expertise to local and global teams to ensure compliance and strategic alignment.


* Deliver on-time and high-quality submissions and approvals for CTA, NDA/BLA, variation, renewal, etc.


* Serve as the primary liaison with regulatory agencies.

Lead HA meetings and oversee their preparations.

Drive the responses to HA queries and ensure effective communication with HA .


* Monitor and interpret changes in drug registration related regulations and guidelines.

Assess their impacts on both existing products and future developments, and adapt strategies accordingly.


* Establish and maintain strong relationships with regulatory authorities and key stakeholders within the local, regional, and global organization to facilitate effective communication and collaboration.


* Ensure regulatory activities in compliance with the regulations, company rules and RA department’s SOPs.

Qualifications & Competencies


* Bachelor’s degree or higher in Chemistry, Pharmaceutics, Biology, or a related life-science discipline.


* A minimum of 8 years of regulatory affairs experience within a multinational pharmaceutical company is required, with a preference for regulatory experience in biologic products and immunology.


* Strong lobbying and negotiation skills, paired with excellent leadership qualities and a team-oriented spirit.

Highly adaptable with a strong ability to learn and thrive under pressure.


* Exceptional verbal and written English communication skills, with the ability to convey complex regulatory information clearly to diverse audiences.


* Proficient in slide preparation with strong presentation skills.