Icon hamburger
Briefcase

Create Job Alert.

Enter your email below to save this search and receive job recommendations for similar positions.
Thank you. We'll send jobs matching these to
You already suscribed to this job alert.
No Thanks
US
What job do you want?
Apply to this job.
Think you're the perfect candidate?
Apply Now
Project Manager at The Judge Group

Project Manager

The Judge Group Collegeville, PA Full-Time
Apply Now

Create Job Alert.

Get similar jobs sent to your email

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.
Basic Qualifications:

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.
Preferred Qualifications:

  • 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
  • Strong interpersonal skills

Contact: [ Link removed ] - Click here to apply to Project Manager
This job and many more are available through The Judge Group. Find us on the web at [ Link removed ] - Click here to apply to Project Manager
 

Recommended skills

Interpersonal Skills
Assertive
Attention To Detail
Communication
Time Management
Creativity
Apply to this job.
Think you're the perfect candidate?
Apply Now

Help us improve Careerbuilder by providing feedback about this job: Report this job

Report this Job

Once a job has been reported, we will investigate it further. If you require a response, submit your question or concern to our Trust and Site Security Team

Job ID: 674260

Careerbuilder TIP

For your privacy and protection, when applying to a job online, never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction. Learn more.

By applying to a job using Careerbuilder you are agreeing to comply with and be subject to the Careerbuilder Terms and Conditions for use of our website. To use our website, you must agree with the Terms and Conditions and both meet and comply with their provisions.