Senior Regulatory Affairs Manager - CMC
- Adherence to AZ code of conduct, ethics and good regulatory practices including AZC RA SOPs and other required SOPs
- Align with the values and vision of AZ
- Maintain regulatory compliance with Local legislation, Global regulatory policies, AZ code of conduct
- Maintain company confidentiality (i.e. intellectual property, product information and strategic information)
- Disclose potential breach of codes or conduct
- Follow SOP requirements especially on documentation
- Develop and communicate biologics CMC regulatory strategy
- Analysis regulatory requirements, constraints and risk and changing trend
- Develop CMC regulatory strategies
- Communicate CMC regulatory strategies, risk and mitigation plan to stakeholders.
- Identify, assess impact & proactively communicate changes to local regulations.
- Establish effective networks with manufacturing sites and relevant technical functions
- Develop change strategies for products in developing stage and lifecycle management protocols
- Lead centralised biologics CMC regulatory project, providing the support and coordination on CMC dossiers preparation, submission and response.
- Provide strategic, tactical and operational expertise and direction to China RA team, based on understanding of CMC regulations
- Provide cross-functional coordination on CMC dossiers preparation and submission
- Ensure project activities are delivered to a high standard and agreed time scales.
- Lead CMC project driven regulatory interactions with health authorities
- Drive and lead discussions related to queries from HA, ensuring completeness of responses within requested timelines, and compliance of additional CMC information requests.
- Advocate AZ positions consistently at various taskforces in industry association
- Provide technical support and tactical coordination on CMC dossiers during preparation and submission
- Master or above in Pharmacy, Medical, Biology or related fields
- Possess a high degree of honesty with a track record built on success stories and sound ethics, have a proven track record from a major pharmaceutical company.
- Fully understand the current regulatory practices and regulation in China, the authority structure and relationship among different regulatory bodies, knowing and building the relationship with some key customers.
- Strong ability on team work and building solid trust partnerships among peers and junior staff.
- Excellent verbal and written communication skills and good enough English, fluent in English reading/writing/listening/speaking.
- Able to work with a keen sense of urgency and priority, task oriented with a “Big Picture” approach.
- Good project management skill and experience.
- > 5+ years working experiences in RA CMC or related roles.
- Working experiences in drug research & development/manufacturing & quality control/reviewing is an advantage.
- 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
【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.
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.