(Sr.) Manager, Regulatory Affairs-CMC (Gene Therapy)
As a Regulatory CMC Expert, this role is responsible for assisting RA CMC Director to develop and communicate CMC regulatory strategy based on understanding of local CMC regulations, involved in CMC regulatory project, providing the support and coordination on CMC dossiers preparation, submission and response; providing technical support and tactical coordination on CMC dossiers during preparation and submission.
Typical Accountabilities
- Contribute to develop and communicate CMC regulatory strategy, involved in analysing regulatory requirements, constraints and risk and changing trend, Identify, assess impact & proactively communicate changes to local regulations.
- Participate in developing change strategies for products in developing stage and lifecycle management protocols, involved in establishing effective networks with manufacturing sites and relevant technical functions
- Support with providing strategic, tactical and operational expertise and direction to China RA team, based on understanding of CMC regulations, Ensure project activities are delivered to a high standard and agreed time scales.
- Support to define the content required for CMC submissions with local RA team and global counterpart; Keep improving quality of CMC dossiers in CTA/NDA/variation submission
- Adherence to AZ code of conduct, ethics and good regulatory practices including AZC RA SOPs and other required SOPs
Education, Qualifications, Skills and Experience
Essential
Academic / Professional Qualification
- Bachelor degree or above in Pharmacy, Biology or related field.
Technical / Skills Training
- Have a proven track record from leading pharmaceutical companies.
- Fully understand the current regulatory practices and regulation related to CMC in China.
- Good networking with regulatory authorities.
- Strong collaboration across R&D teams.
- Excellent verbal and written communication skills and fluent in both oral and written English.
- Able to work with a keen sense of urgency and priority, task oriented with a “Big Picture” approach.
- Good project management skill and experience.
Working Experience
- Minimum 2 years’ experience in below position in MNC as regulatory profession and qualified competence.
- Minimum 5 years working experiences in RA CMC or related roles.
- Working experiences in drug research & development/manufacturing & quality control/reviewing is an advantage.
- Experience in complex regulatory environment assessment.
- Experience in crisis management.
Desirable
- Experience in drug/biologic manufacturing is a plus.
- China Pharmacist is plus.
【AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised. 阿斯利康是一家提供平等机会的企业，我们将考虑所有符合条件的求职者就业。不因残疾、性别或性取向、怀孕或产假状况、种族或民族或族裔出身、年龄、宗教或信仰、性别认同或变更、婚姻或伴侣关系、受保护的退伍军人身份（如果适用）及任何其他受法律保护的特征而产生歧视。】
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.
