Associate Director, Regulatory Affairs CMC Job Description Template
Our company is looking for a Associate Director, Regulatory Affairs CMC to join our team.
Responsibilities:
- Provide support to Senior Director, Regulatory Affairs CMC as requested;
- Continue professional development by attending regulatory CMC-related meetings applicable to biopharmaceutical products;
- Represent Regulatory Affairs CMC in project meetings as assigned.
Requirements:
- Excellent written and verbal communication skills;
- Direct experience assembling Regulatory applications in eCTD format;
- Highly flexible, adaptable and experienced in a fast-paced environment;
- Expertise in MS Office; experience with Electronic Document Management Systems for preparing, formatting, and finalizing regulatory submissions;
- Knowledge of FDA, ICH and EMA requirements for biopharmaceutical products required;
- Strong project management and organizational skills with ability to multi-task on several projects.