Associate Registration Manager

1 month ago


Beijing, Beijing, China Pfizer Full time

Job Summary

The Associate Registration Manager plays a critical role in ensuring the regulatory compliance of Pfizer's products in China. This includes preparing and submitting regulatory submissions to the Chinese authorities, collaborating with cross-functional teams, and maintaining a high level of product knowledge.

Key Responsibilities

1. Prepare and submit regulatory submissions for new products, variations to marketed products, and clinical trial applications.

2. Analyze data packages for regulatory compliance and identify discrepancies in data presented.

3. Develop an overall perspective of registration projects and ensure timely submission of all quality and safety relevant variations.

4. Collaborate with the global regulatory and clinical development team to develop new products and inline products strategies.

5. Partner with PGS and Pharma Sciences to implement China GMP, Chinese Pharmacopeia, and other China regulatory requirements in PGS sites.

Qualifications/Skills

1. Strong customer focus sense and excellent communication and interpersonal skills.

2. Excellent teamwork and collaboration skills, with the ability to work under pressure in a busy environment.

3. Good working knowledge of international and local regulatory guidelines and codes, as well as Microsoft Word, PowerPoint, and Excel.

4. Excellent English skills in speaking, reading, and writing.

Cultural Competencies

The Associate Registration Manager will demonstrate the following cultural competencies:

1. Sustain focus on performance.

2. Create an inclusive environment.

3. Encourage open discussion and debate.

4. Manage change.

5. Develop people.

6. Align across Pfizer.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.



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