Associate Director, Regulatory Affairs CMC

Iovance Biotherapeutics

23h•Remote

About The Position

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.

Requirements

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

Nice To Haves

Graduate degree preferred

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.