Title: Associate Director/Director of Regulatory Affairs
Cellics Therapeutics is searching for an Associate Director/Director of Regulatory Affairs. The Associate Director/Director of Regulatory Affairs is responsible for developing practical and workable regulatory plans and strategies for development stage drugs based on regulatory requirements, maintaining effective communications with the regulatory agencies, ensuring timely preparation, review, and submission of documents to regulatory agencies, and maintaining compliance with applicable regulatory requirements to achieve corporate goals effectively.
Essential Duties and Responsibilities:
- Oversees and leads CMC, non-clinical, and clinical regulatory strategies.
- Identifies optimal regulatory routes and develops regulatory strategies and plans.
- Directs efforts for the planning and execution of required regulatory filings; oversees the development and writing of submission contents and documents and provides guidance when appropriate.
- Works with project teams to resolve complex issues from a regulatory perspective.
- Utilizes regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure approvals are obtained.
- Plans, prepares, and executes strategies for meetings with regulatory agencies on complex and strategic programs; negotiates complex issues with regulatory bodies and builds rapport with regulators to best position the programs for positive outcomes.
- Assess regulatory risks and communicate them to the project teams and management; proposes mitigation approaches.
- Provides critical review of documentation supporting regulatory applications; analyze and resolve submission issues and identify new content as needed.
- Ensures regulatory affairs activities are aligned to project timelines & business objectives and also compliant with ICH, FDA, HC, and EU regulations.
- Maintains updated knowledge of regulatory environment, regulations, systems, and guidance and understands external trends.
- Interacts with company partners and consultants for various regulatory matters as needed
- Contributes regulatory perspective as needed on government proposals and external due diligence activities
- Contributes to the modification, development, and implementation of company policies and procedures for regulatory affairs.
- Provides input for department budget
- Bachelors/Masters/Doctors degree in a life science discipline or equivalent, advanced degrees are preferred.
- At least 8 years of experience in Regulatory Affairs in a pharmaceutical company or biotech company.
- Extensive experience working with the FDA and other Regulatory Authorities, with proven successful regulatory submissions track records including IND, BLA, and MAA.
- Experienced in vaccine product development.
- Experience in the preparation and submission of regulatory documents from early stage to later stage.
- Knowledge of global regulations / guidance and thorough knowledge of biological/ drug development process required.
- Strong strategic and critical thinking, diplomacy, negotiation and excellent oral and written communications skills.
- Ability to understand and apply technical materials and regulations, strong technical writing skills, knowledge of CMC.
- Broad knowledge of biopharmaceutical manufacturing, operations, and development and ability to apply that knowledge to complex regulatory issues.
- Strong interpersonal skills and ability to communicate effectively and maintain good relationships even when dealing with demanding, complex or controversial issues.
- Strong strategic, analytical, and negotiation abilities.
If interested, please email a copy of your CV to email@example.com.