RA CMC - Director
- 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 CMC regulatory strategy
- Analyse CMC regulatory requirements, constraints, risk and changing trend
- Develop CMC regulatory strategies
- Communicate CMC regulatory strategies, risk and mitigation plan to stakeholders
- Identify local regulation changes, assess impact & proactively communicate to stakeholders
- Establish effective networks with manufacturing sites and relevant technical functions
- Develop change strategies for products in developing stage and lifecycle management protocols
- Exert external influence and shape the regulatory environment in China
- Monitor and analyse requirements gap between global and local documentation
- Advocate AZ positions consistently at various meetings and conferences
- Influence key external stakeholders, in line with codes of conduct, to improve regulatory outcomes
- Reach an internal consensus among different functions while complying with local requirements
- Lead and guide centralized CMC regulatory projects and regulatory interactions and advocacy with HA
- 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.
- Drive and lead discussions related to queries from HA, ensuring completeness of responses within requested timelines, and compliance of additional CMC information requests
- Provide technical support and tactical coordination on CMC dossiers during preparation and submission
- 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
- Attend communication meeting with HAs as CMC expert
- CMC team and knowledge management
- Undertake effective knowledge sharing within China RA team
- Supervise and coach junior team members to execute the regulatory activity and achieve business objectives
Education, Qualifications, Skills and Experience
- Master or above in Pharmacy, Medical, Biology or related field
- 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 management 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.
- > 10 years above in MNC as regulatory profession and qualified competence.
- Experience in handling complex regulatory projects, various kinds of regulatory submissions/approvals and experiences in involving into the development projects are required;
- Experience in complex regulatory environment assessment;
- Experience in crisis management
- At least 3 years people management experience with demonstrated leadership and management skill in leading a team.
- 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.
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.