Regulatory Affairs Specialist
7 days ago
About Us
Pfizer is a global biopharmaceutical company that applies science and our global resources to deliver innovative therapies that extend and significantly improve lives. We are committed to becoming the premier, most respected biopharmaceutical company in the world.
Job Summary
We are seeking an experienced Associate Registration Manager to join our Regulatory Sciences team in China. The successful candidate will be responsible for assisting with the regulatory maintenance of a portfolio of products, including preparation of regulatory submissions to Chinese authorities and collaborating with cross-functional teams to ensure timely compliance with local and international regulations.
Key Responsibilities
The Associate Registration Manager will be responsible for:
- Preparing regulatory submissions for registration of new products, variations to marketed products, and clinical trial applications;
- Critically analyzing data packages for regulatory compliance and identifying discrepancies in data presented;
- Developing an overall perspective of registration projects;
- Preparing responses to deficiency letters and ensuring timely submission to regulatory agencies;
- Maintaining contact with officials of Chinese regulatory agencies to determine regulatory requirements and expedite approvals;
- Maintaining up-to-date knowledge of relevant legislation in China;
- Providing regulatory advice to company personnel as required;
- Partnering with the global regulatory and clinical development team for new product development strategy and inline products strategy;
- Collaborating with PGS and Pharma Sciences for implementation of China GMP, Chinese Pharmacopeia (CHP), and other China regulatory requirements;
- Ensuring timely communication of CHP and other China regulations to PGS QO and GCMC to facilitate implementation;
- Ensuring local processes are in place for timely submission of quality and safety-relevant variations, including labeling safety updates and specification/manufacture process changes;
- Participating in special projects for the Regulatory Sciences Group;
- Attending Regulatory Sciences, Medical Department, and other internal meetings as required;
- Providing resource support to other sections of the company for specified therapeutic areas;
- Completing Pfizer PRE Safety Reporting Process: Overview training module within set timeframe;
- Completing related training;
- Attending and actively participating in personal development courses as required;
- Attending training in specific therapeutic areas as required;
- Participating in Regulatory Sciences and Medical Department projects and workshops.
Requirements
The ideal candidate will have:
- Tertiary qualifications in pharmacy or a science degree with a pharmacology major;
- At least 3 years' experience in regulatory sciences working;
- Strong customer focus sense;
- Excellent communication & interpersonal skills;
- Excellent teamwork/collaboration;
- Result-oriented;
- Quality orientation;
- Excellent ability to research information;
- Able to work under pressure in a busy environment;
- Good working knowledge of international and local regulatory guidelines and codes;
- Good working knowledge of Microsoft Word, PowerPoint, and Excel;
- Excellent English skill in speaking, reading, and writing;
- Cultural competencies (leader behaviors) such as sustaining focus on performance, creating an inclusive environment, encouraging open discussion and debate, managing change, developing people, aligning across Pfizer.
Estimated Salary Range
$80,000 - $120,000 per annum, depending on experience and location.
Benefits
Pfizer offers a comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, paid time off, and opportunities for professional growth and development.
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