Director, Regulatory Affairs (HL19-197)
We are currently seeking to hire a motivated Director of Regulatory Affairs who will report to the Vice President of Regulatory Affairs. Responsibility includes nonclinical, clinical and CMC regulatory filings and providing operational leadership on the project teams in these areas as well as strategic thinking. The candidate will develop manage IND and NDA submissions, FDA and other regulatory interactions, as well as international submissions, and regulatory strategies for the product candidates.
- Responsible for filing of IND/CTA/NDA/MAA submissions. Set strategic sequencing for submissions of product registration documents to health authorities worldwide.
- Interacts with other functions and external vendors, as necessary, in the preparation, review, and completion of documents for regulatory submissions.
- Provide interpretation of regulatory authorities’ feedback, policies and guidelines to Catalyst’s personnel and serve as a liaison between Catalyst and regulatory authorities.
- Represent Catalyst before regulatory authorities on designated programs.
- Utilizes regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure governmental approvals are obtained.
- Effectively plan, organize, and conduct, in close collaboration with leads from other functional areas and external vendors, formal meetings with regulatory agencies.
- Interact with key personnel in regulatory agencies to ensure the review and approval of development plans, the timely resolution of issues, and the approval of marketing applications.
- Assure compliance with project team timelines and milestones.
- Provide organizational support and be prepared to manage personnel as company grows its product development pipeline.
- Perform other duties as assigned.
- Advanced degree MD, PharmD, or PhD preferred
- 10 years of biopharmaceutical experience, which include at least 8 years of direct experience in Regulatory Affairs and have successfully filed IND and NDA/MAA submissions
- Ability to effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company.
- Must be well organized, polished, proactive, detail-oriented, mature and have a professional demeanor
- Ability to multi-task and work efficiently in an environment with changing priorities
- Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings is essential and required.
- Demonstrated skills in Catalyst’s Core Competencies:
- Drive, Intensity, Enthusiasm
- Goal Orientation/Commitment to Task/Follow-up
- Attention to Quality & Detail
- Decision Making & Problem Solving
- Ownership & Accountability
Thank you for your interest in Catalyst Biosciences! You may apply for this position by sending your CV/resume to email@example.com, referencing requisition number HL19-197 in the subject line.