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DIRECTOR OF GLOBAL REGULATORY AFFAIRS - CELL/GENE THERAPY

BOSTON, MA · Biotech/Pharmaceutical
Position Overview:

This position will provide input into the product strategy and to the direction provided to commercial and clinical teams. Incumbent will provide dedicated regulatory CMC support for gene and cell therapies, be responsible for assuring the established regulatory strategy is aligned with Health Authority requirements from a global perspective and assuring that regulatory submissions are on time and high quality. Additional duties include coordination with our Genomics Medicines Unit, integration of regulatory strategy with our sites and communication to cross-functional teams and senior management. Regulatory knowledge regarding innovative biologics, gene- and cell-therapy development, manufacturing, and analytical testing are essential. The incumbent has a patient- and quality-focused mindset and drives a culture of continuous improvement in compliance with our behavioral and ethical standards. 

Major Activities/Key Responsibilities:

Leads and manages a subteam of the product range for innovative biologics, gene- or cell-therapies

Manages and supervises a sub-team in the product range and develops staff.

Contributes to strategy and planning in the product range.

Supports Global RA and Product Range objectives.

Provides senior CMC regulatory expertise and guidance 

Oversees and reviews regulatory CMC strategies of the assigned team.

Participates in peer reviews of CMC regulatory strategies.

Supports development, review and alignment of cross-product RCMC positions and regulatory dossier templates.

Represents GRA CMC Biologics in internal and industry association teams to influence policy and practice on gene- and cell therapy CMC.

Acts as GRA CMC Biologics Product Focal Point for assigned products

Takes the role of the GRA CMC Biologics representative in project / product teams  

Represents GRA CMC Biologics in Global CMC and Global Regulatory Team(s) and meetings, partners with the leaders of these teams to facilitate successful product development.

Provides accurate regulatory assessments and expertise input to team recommendations.

Facilitates together with the CMC teams and regional/local regulatory experts the planning and execution of regulatory actions (submissions, meetings, etc.).

Communicates project plans, status and updates to management.

Develops and executes global regulatory CMC strategy for assigned product 

Gathers and assembles needed CMC source information, regulatory requirements relevant for the product, regulatory intelligence in the field.

Develops, aligns and formulates the global regulatory CMC strategy and writes strategy documentation.

Provides interpretive analyses of regulatory guidance, regulations, or directives that impact product(s) or CMC operations.

Supports CMC regulatory risk assessments, and drives contingency planning and mitigation of identified regulatory risks.

Manages global regulatory submissions and dispatches of CMC packages for new applications / maintenance-, amendment-, supplement-, response submissions etc.

Plans submissions and CMC dossier/package strategies per the product’s global CMC regulatory strategy for CTA/INDs, BLA/MAAs, international MAs, HA meetings, maintenance submissions, change amendments/supplements, commitments, etc.

Determines and gains alignment on the required content for CMC dossiers and timelines.

Coordinates and supports dossier preparation, review and publishing process in line with project timelines.

Manages regulatory databases for planning and tracking of regulatory submissions.

Manages CMC related Health Authority liaison and communication 

Interacts and liaises with FDA, EMA on product and CMC topics, coordinates health authority interactions on CMC topics with international Health Authorities and together with local/regional teams.

Leads the Regulatory CMC content of meetings with FDA, EMA, supports Health Authority meetings as SME in international countries.

Communicates outcomes of health authority procedures or feedback to teams and management.

Tracks HA communication and questions/responses in regulatory databases.

Supports compliance requirements and activities

Provides CMC regulatory input to change management processes.


Basic Qualifications:

University degree in a life sciences discipline, PhD or MSc preferred.

 

Strong background in either of the fields of gene or cell therapy applications, genome editing, mRNA vaccination, CAR-T, NK-cell technologies.

 

10+ years experience in regulated pharma environments (research, development, manufacture or analytics) or as technical/scientific reviewer at competent authorities.

 

Proven expertise / experience with developing global regulatory CMC strategies for gene- and cell therapy products, leading regulatory submissions and health authority interactions. Ideally experience with late stage development / commercial gene- or cell therapy products.

 

Sound understanding of ICH and major markets’ regulations on biologics and advanced therapeutic modalities.

 

Experience in managing people in either a project or functional context.

 



Preferred Skills:

Good understanding of the competition in the area of gene and cell therapies is preferred.

Experience in working with industry associations and policy groups.

Excellent organizational and communication (written and verbal) skills.

Proficient in using digital tools (MS Word, Excel, PowerPoint, regulatory databases and document management systems).

Previously worked in an international, matrixed, fast-paced environment.

Previously worked with external collaboration partners and/or CROs/CMOs.

Regulatory certifications preferred.
KP RECRUITING GROUP
 
KP Recruiting Group was started to create a world-wide network of multi-level, highly skilled talent; that are either experts or working to become one, in their respective fields. Our process involves focusing on the talent, skills, and experience of an individual as a key indicator of the present and future value that they will bring to any organization.

In establishing a network, we are able to forge genuine relationships with talent and gain valuable insight that allows us to understand what motivates them. This data allows us to give strategic advice to our partners as they go through the process of managing their human capital.

See our jobs and apply here: https://kprecruitinggroup.catsone.com/careers/7781-General

 
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