As a CMC-RA Associate II, you will play a crucial role in supporting Chemistry, Manufacturing, and Control (CMC) documentation for regulatory submissions. You will collaborate with cross-functional teams to ensure compliance with global CMC regulations and contribute to the development of high-quality regulatory submissions.
Key Responsibilities:
- Assist in preparing and formatting regulatory submissions (original and post-approval).
- Ensure compliance with global CMC regulations and guidelines.
- Maintain regulatory documentation and track submission deliverables.
- Support project teams with regulatory advice and submission strategies.
- Conduct research on regulatory requirements from global health authorities.
- Participate in process improvement initiatives.
Qualifications & Experience:
- Education: Degree in Pharmacy, Chemistry, Biology, or related field.
- Experience: Minimum 6 years in biopharma, regulatory affairs, or quality assurance.
- Skills: Strong teamwork, IT proficiency, regulatory knowledge, and attention to detail.
- Preferred: Knowledge of monoclonal antibodies, biotechnology regulations, and Lean methodologies.
2. CMC-RA Manager I (Submission Excellence & Project Management)
Job Description:
The CMC-RA Manager I will lead global CMC regulatory submissions, ensuring compliance and timely approvals. This role involves managing project timelines, regulatory documentation, and cross-functional collaboration to support product lifecycle management.
Key Responsibilities:
- Lead CMC submissions for global markets, ensuring compliance with regulatory standards.
- Manage project timelines and deliverables for on-time submissions.
- Provide regulatory expertise and guidance to internal teams.
- Maintain Health Authority approval documentation.
- Drive process improvements and efficiency in regulatory workflows.
Qualifications & Experience:
- Education: Bachelor’s/Master’s in Pharmacy, Chemistry, or Biological Sciences.
- Experience: Minimum 8 years in biopharma, regulatory CMC, or project management.
- Skills: Strong leadership, regulatory knowledge, and project management expertise.
- Preferred: Experience with biologics, synthetic drugs, and Lean practices.
Why Join AstraZeneca?
- Innovative Work Environment: Work on cutting-edge therapies in Oncology and Biotechnology.
- Career Growth: Opportunities for professional development and leadership roles.
- Hybrid Work Model: Flexible work arrangements (minimum 3 days/week in office).
- Global Impact: Contribute to life-changing medicines for patients worldwide.
