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29 days old

GRA CMC Manager Gene Therapy

Kelly Services
King of Prussia, PA 19406
**Job Summary**


The GRA CMC Manager Gene Therapy is responsible for CMC regulatory activities related to product development, registration, and license maintenance for the assigned products of the gene therapy portfolio.


As a permanent member of the Global Regulatory Affairs Strategy Team(s) (GRAST(s)) and/or of relevant CMC Regulatory Sub-Team(s), this individual develops and implements global CMC regulatory strategies regarding product development, clinical trial applications, new license applications, product changes and relevant CMC projects related to the assigned products of the gene therapy portfolio.


For established products which are no longer in clinical development the GRA CMC Manager may be appointed as Global Regulatory Lead. In this role, this individual will chair a GRAST and be accountable for successful product lifecycle management.


Responsible to work in an efficient, productive, and harmonized fashion to be the CMC regulatory subject matter expert for the assigned tasks and activities. Contributes to the development of global regulatory processes in agreement with their supervisor. Interprets existing or new regulatory requirements, evaluates draft guidelines, and writes impact assessments.


May provide technical guidance to GRA CMC Scientists and/or Specialists and support them for organization and prioritization of submission activities. If required, deputizes for the GRA CMC Team Lead Gene Therapy.


Responsible for operational CMC regulatory activities related to the assigned products and/or intermediates, including as applicable:


+ Maintenance of the content of relevant parts of the regulatory dossiers.

+ Preparation, revision and review of Module 2.3, Module 3, required facility and equipment information and related documents for new product registrations (e.g. MAAs, BLAs) and lifecycle submissions according to agreed timelines and taking regional regulatory requirements into account. This may include technical authoring of dossier narratives and other regulatory CMC documentation.

+ Timely provision of high-quality responses to CMC related Health Authority questions.

+ Compilation and review of CMC information for CTAs, INDs and other regulatory submissions related to product development (e.g. CMC documentation for Scientific Advice Meetings, Briefing Books, IBs).

+ Provision or support of timely and compliant regulatory assessments as well as efficient execution of CMC changes.

+ Preparation and review of CMC related information and documentation required for tenders, PSURs, DSURs, CCDS/product information and promotional materials.

+ Regulatory contribution to annual product quality reviews and risk assessments.

+ Responsible for strategic CMC regulatory activities related to the assigned products of the gene therapy portfolio, including as applicable:

+ Is a permanent member of the Global Regulatory Affairs Strategy Team(s) (GRAST(s)) and/or of relevant CMC Regulatory Sub-Team(s).

+ May represent Global Regulatory Affairs in Project Strategy Teams for CMC projects and/or cross-functional sub-teams.

+ Is responsible for development and implementation of global CMC regulatory strategies for product development, clinical trial applications, new license applications, product changes and relevant CMC projects with a view to reach approvals in the most efficient way while ensuring compliance with global regulatory requirements.

+ Is the primary GRA contact point interfacing with relevant technical expert departments for project planning purposes, compilation, and updates of technical documentation and for addressing CMC regulatory questions.

+ Evaluates the available technical and scientific CMC information for compliance with regulatory requirements, performs gap analysis and proposes solutions and strategies to remediate risks.

+ Supports scheduling and prioritization of CMC related submissions.


**May be appointed as Global Regulatory Lead for established products which are no longer in clinical development. This responsibility includes:**


+ Chairs the related Global Regulatory Strategy Team(s) (GRAST(s)).

+ Is accountable for the regulatory contribution to successful product lifecycle management in alignment with key internal stakeholders (e.g. Commercial, Operations, Safety).

+ Leads and oversees the development and alignment of global regulatory strategies for product lifecycle management activities within the GRAST. Ensures integration of regional regulatory requirements, adequate documentation and pro-active adaptation of strategies to ensure incorporation of new information and start-of-the-art regulatory intelligence.

+ Coordinates and tracks compilation of regulatory documentation required to support new product registrations and relevant lifecycle submissions (e.g. renewals) within the GRAST.

+ Oversees scheduling and prioritization of all regulatory submissions for the assigned products.

+ As required, presents regulatory strategies, risk assessments and mitigation proposals to senior review committees such as GRA Therapeutic Areas (GRA TA Teams) or Global Lifecycle Review Board (GLRB).


\#P2


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **Science & Clinical?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

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Posted: 2022-08-29 Expires: 2022-09-29

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GRA CMC Manager Gene Therapy

Kelly Services
King of Prussia, PA 19406

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