Proclinical is advertising a vacancy for a Senior Regulatory Executive position with a leading global pharmaceutical company that develops products across multiple therapy areas including cardiovascular, oncology, and respiratory. The organization is seeking for a driven and motivated Executive to join their team in Pennsylvania. This is an exciting opportunity to join a top 10 company and bolster a career in the regulatory field.
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. The individual will work collaboratively and proactively within the CMC project team and across multiple functional areas to manage the response activities to develop the strategy, scope, and 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 team to execute plans for managing workload within assigned project objectives through efficient resource utilization 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.
- Organizing and archiving CMC dossier components and supporting documents in appropriate document management systems.
- Interfacing with regulatory operations staff to coordinate dossier review, approval, and publishing activities.
Skills and Requirements:
- Bachelor's degree in life sciences or related scientific discipline.
- At least 5 years of experience in pharmaceutical or biotechnology drug development, with direct involvement in CMC-related activities and functions.
- Experience in authoring CMC content for regulatory submissions is required, preferably with a minimum of 2 years in regulatory affairs or related function.
- Strong technical writing skills and attention to detail.
- Strong verbal communications skills and demonstrated ability to work in a matrix/team environment.
- Ability to effectively plan, prioritize and co-ordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines.
- Strong computer skills in Microsoft Office applications with the ability to learn new applications quickly and easily.
- 2 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.
- field force, the advantages of co-promotion, and how to maximise product potential.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
- Mid-Senior Level.
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 contact Sarah Bershara at +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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