Location: Collegeville, PA Description: Our client is currently seeking a Project Manager
As a CMC Regulatory Project Manager, you will be based at our Collegeville, PA site, however this role will interact across our global network. Reporting to the Director of CMC Regulatory Affairs, this position will plan and coordinate regulatory strategies necessary to support clinical development submissions, new registrations, and post approval submissions that meet global regulatory requirements and company business goals. The position will include projects in clinical development to study and commercialize important new COVID-19 therapies.
You will manage, or be responsible for, the global CMC regulatory activities for assigned projects and respond readily to changing events and priorities.
You will be responsible for the strategy development and creation of CMC submission documents from early phase clinical submissions (IND/IMPD) through to marketing applications (BLA/MAA) and lifecycle management activities.
You will need to understand, interpret and advise teams on regulations, guidelines, procedures and policies relating to development, registration and manufacture of new biopharmaceutical products, to expedite the submission, review and approval of global CMC applications.
You will work in cross-functional matrix project teams, which include colleagues from regulatory, biopharmaceutical development, quality and manufacturing.
You will maintain high quality standards and seek to raise levels of performance through continuous improvement and an innovative approach in responding to the evolving regulatory environment.
We are looking for professionals with these required skills to achieve our goals:
Bachelor’s degree (or equivalent) within a relevant subject such as biology, pharmacy, chemistry or a related scientific discipline,
At least 3 years of pharmaceutical company experience.
If you have the following characteristics, it would be a plus:
Chemistry, Manufacturing and Controls (CMC) regulatory affairs or biopharmaceutical development experience with direct involvement in regulatory submission preparation.
Knowledge of worldwide CMC regulatory requirements and successful track record of delivering dossiers that comply with these, particularly for new medicines in development.
Knowledge of the drug development and manufacturing and supply processes
Understanding of FDA regulations and ICH guidance pertaining to pharmaceutical development of NMEs and marketed products.
Good time management skills with the ability to effectively plan, prioritize and co-ordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines.
Strong verbal and written communication skills.
Ability to work independently with minimal supervision as well as in a team environment.
The ability to successfully influence and negotiate issues at the appropriate level within your organization and/or with regulatory agencies in a variety of settings.
Good problem-solving skills to evaluate technical information and identify appropriate regulatory strategies and actions.
Proven ability to develop and implement regulatory strategies and evaluate the potential impact of them on overall project/product strategy.
Ability to find innovative solutions to complex problems and involvement in continuous improvement initiatives.
Experience of Agency interactions and/or submissions in US, EU, Japan and China.
Resourceful, creative, enthusiastic, and results-oriented
Self-motivated, assertive, self-confident and acts with a sense of urgency and passion
Proven ability to work with a high level of integrity, accuracy, and attention to detail
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