Proclinical is pleased to advertise an exciting vacancy for a Senior Regulatory Executive on behalf of a top 10 global pharmaceutical company. This prestigious organisation develops innovative products across multiple therapy areas including cardiovascular, oncology, and respiratory fields.
Located in Pennsylvania, the Senior Regulatory Executive will be directly responsible for managing CMC post-approval activities for a biopharmaceutical product approved in US, EU, Japan, and ROW markets. They will work collaboratively and proactively within the CMC project team and across multiple functional areas, managing the response activities to develop the strategy, scope, and the content of the CMC sections of the responses.
Job Responsibilities:
- Providing guidance to functional area authors/reviewers with regards to submission and dossier requirements.
- Understanding, interpreting, and advising on regulations, guidelines, procedures, and policies relating to the development, manufacture, and successful global registration of biopharmaceutical products.
- Directly managing completion of multiple dossier components to meet project timelines.
- Reviewing documents and dossier components to assure that technical/regulatory strategy and data integrity processes are followed.
- Ensuring that dossier components meet global/regional standards for content, quality, and regulatory requirements.
- Working closely with project team members and CMC regulatory team to produce high quality submissions.
- Working closely with project management and CMC regulatory teams to execute plans for managing workloads within assigned project objectives through efficient resource utilisation, and within designated timeframes.
- Effectively adjusting plans to deal with changes and obstacles.
- Identifying, documenting, and communicating regulatory project risks that could impact timeline and quality of regulatory submissions.
- Organising and archiving CMC dossier components and supporting documents in appropriate document management systems.
- Interfacing with regulatory operations staff to coordinate dossier reviews, approval, and publishing activities.
Skills and Requirements:
- Bachelor's degree in life sciences or related scientific discipline.
- At least five years of experience in pharmaceutical or biotechnology drug development, with direct involvement in CMC-related activities and functions.
- Demonstrable experience in authoring CMC content for regulatory submissions is required, preferably with a minimum of 2 years in regulatory affairs or related function.
- Two or more years of CMC regulatory affairs experience with biopharmaceutical products e.g., monoclonal antibodies and therapeutic proteins.
- Basic knowledge of FDA and EU CMC regulatory requirements.
- Experience with preparation of CMC submissions (INDs, IMPDs, amendments, BLA/MAA).
- Ability to track multiple dossier components and manage successful completion of components for submissions.
- Understanding of dossier development and formatting requirements, document and dossier management.
- Proficiency with Electronic Document Management Systems, preferably Documentum, and publishing tools such as Adobe Acrobat.
- Expert knowledge and hands-on experience in at least one area related to CMC biopharma product development (e.g. analytical or process development, manufacturing, quality control).
- Excellent communication, presentation, persuasion, and client facing skills.
- Excellent English written and oral skills.
- Strong computer skills in Microsoft Office applications with the ability to learn new applications quickly and easily.
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Sarah Beshara on + 267-477-3355 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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