Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

Overview

The Associate Director, Regulatory CMC works collaboratively within the CMC regulatory and technical operation teams on writing projects for early, late-stage development, and commercial programs. They contribute to the drafting, reviewing and finalization of CMC content and/ or regulatory related documents. The individual also apply writing/editorial expertise to the development of CMC/Quality (Module 3) sections for filing and maintenance of initial INDs, initial CTAs (IMPDs), FDA BLA, EMA MAA, ROW submissions as well as CMC source documents. This position works closely with stakeholders to support corporate and departmental objectives. An important aspect of this role is the planning and management of writing projects. Attention to detail in their work and ability to collaborate with diverse internal and external stakeholders are both important factors for success in this role.

Essential Functions and Responsibilities

• Works closely with functional leaders to 1) create the optimal development path for Iovance product candidates, 2) negotiate optimal development paths within internal cross-functional teams and with health authorities, 3) execute clinical-regulatory development plans on-time and while managing all identified risks.
• Collaborates with RA CMC Product Lead to execute CMC Submission and Authoring strategy for assigned project. 
• Ensures that submission documents and correspondence are of the highest quality in terms of content, organization, clarity of writing, and accuracy.
• Ensures that evolving global regulations, guidelines and health authority expectations, especially those related to cell therapies, are incorporated into program decision making.
• Ensures writing activities meet quality standards and expectations and adhere to applicable Corporate SOPs, policies, guidelines, and regulation.
• Assures that standardized practices are implemented and maintained across regulatory documents.
• Collaborates with Regulatory Operations to ensure timely and accurate submissions
• Critically review source documents for consistency, completeness, and quality.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics
• Perform miscellaneous duties as assigned.  

Required Education, Skills, and Knowledge

• Minimum of a BA/BS in Life Science
• 5-8 years pharmaceutical/biotechnology experience related to analytical/pharmaceutical chemistry and/or regulatory affairs.
• Demonstrated expertise in writing/developing CMC content in Briefing Documents, Quality Amendments, Module 2 and Module 3 updates and CMC source documents in support of US and global regulatory submissions (with primary interest in the areas of Biologic and Cell Therapy Products).
• Understanding of biological lifecycle drug development
• Experience with ICH, CTD and electronic submission guidelines for regulatory reports.
• Excellent written and verbal skills
• Ability to collaborate with a wide variety of internal customers and relate effectively to people at all levels of the organization
• Excellent computer skills including MS Office (Word, Excel, Power Point, Outlook); experience with electronic document management systems and other content authoring technologies (e.g. Veeva Vault)
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Proven track record with project management and experience with GDP, GCP, and GMP. Ability to handle multiple projects simultaneously.
• Excellent attention to accuracy and detail.
• Create and maintain core dossier and CMC Authoring templates

Preferred Education, Skills, and Knowledge

• Graduate degree preferred

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation. 

Physical Demands and Activities Required 

• Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
• Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
• Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.  
• This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
• Must be able to communicate with others to exchange information.

Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines

Work Environment 

This job operates in a professional or remote office environment and requires operating standard office equipment and keyboards.  

#LI-remote

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

Overview 

The Executive Director, Regulatory Affairs is responsible for overseeing the global regulatory clinical strategy development and execution of the regulatory affairs objectives. The Executive Director oversees the development of clinical regulatory strategies for earliest possible approvals of the company’s regulatory applications at all stages of development (e.g., phase 1 through phase 4 and post launch). The Executive Director, Regulatory Affairs is responsible for tracking trends and requirements in the global market, and the impact that the changes will have on the company’s product portfolio. Addresses the analysis and evaluation of regulatory procedures and changes on the company’s products to ensure attainment of financial and strategic goals. Identifies and recommends the most effective path to regulatory approval to bring the company’s products to market in a cost-effective, compliant manner. This position oversees the evaluation and analysis of the impact of trends relative to government regulatory activities on a global basis.

Essential Functions and Responsibilities

• Supports the development and execution of global regulatory strategy for the Company’s pipeline and approved products.
• Ensures the Company maintains a strong regulatory and compliance position in all necessary jurisdictions.
• Maintains relationships with relevant regulatory agencies to improve quality of submissions and understand the impact of any pending or proposed regulatory changes.
• Lead preparations for pre- and end-of-Phase, and scientific advice regulatory agency meetings and advisory committee meetings.
• Communicate directly with regulatory authorities to expedite submissions, and their review and approval.
• Work with contract regulatory organizations to prepare applications, respond to queries, and maintain company’s development activities.
• Assure compliance with applicable regulations.
• Identify risks and interpret and communicate relevant issues to project team members and senior management.
• Educate/train company employees on regulatory matters to ensure compliance with requirements.
• Maintain knowledge of global competitive landscape, regulatory environment, and applicable regulations and guidance documents.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform miscellaneous duties as assigned. 

Required Education, Skills, and Knowledge 

• Bachelor’s Degree with 15+ years’ experience
• Or an advanced degree in the Life Sciences, an MD, PhD or PharmD, with management experience and 10+ years’ experience
• Must have cell or gene therapy experience 
• Experience with filings for oncology products 
• Knowledge of global regulations and guidance as they relate to the overall global regulatory strategy required.
• Proven ability to implement world-wide Regulatory strategies for an organization.
• Strong track record of collaborative working relationship with FDA and other key agencies worldwide which has led to successful outcomes for the business.
• Excellent verbal and written communication skills
• Ability to work within a team environment, report on projects and drive them to conclusion.
• Self-starter who works with a sense of urgency and acts as a good team player working with other disciplines.
• Adaptability, flexibility, independence and resourcefulness to roll-up-sleeves and multi-task in order to thrive in small company environment.

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

Physical Demands and Activities Required

• Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
• Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
• Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
• This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
• Must be able to communicate with others to exchange information.

Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines

Work Environment

This job operates in a professional or remote office environment and requires operating standard office equipment and keyboards. 

#LI-remote