Clinical Trial Submission Manager

Use Your Power for Purpose

We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines

What You Will Achieve

You will direct the development, quality control and publication of submissions relating to asset development and registration, driving adherence to external regulatory guidelines and compliance timelines for multiple submission types. You will provide strategic direction to teams on regulatory logistics and serve as a regulatory operational liaison on the project team throughout the product lifecycle.

In this role, you will:

• Provide guidance, lead/co-lead projects, manage own time to meet objectives and plan resource requirements for projects across the department.
• Drive global submission management activities for the assigned assets, prepare, review and submit submissions to relevant stakeholders, in order to obtain all necessary authorizations/ approvals for the clinical trials.
• Coordinate submission production and assist with definition, development and implementation of global submissions policies and technologies to meet evolving business needs.
• Escalate, inform and resolve any issues that may impact submission builds or the logistics of global submission delivery to regional and local partners or Health Authorities.
• Promote the use of Document Management and Archival systems and standard document authoring, partnering with supplier groups as necessary in order to produce timely delivery of submission/archive ready components.
• Lead the interpretation of dossier requirements to produce business processes and ensure that those processes are implemented where appropriate at global and local level.
• Implement strategies that achieve operational excellence through interaction with global regulatory leaders and associated product teams.
• Support leadership to produce business processes by understanding regulatory guidelines and requirements.
• Make decisions to resolve moderately complex problems, develop new options, and operate independently in ambiguous situations, guided by policies in non-standard situations.
  
  

Here Is What You Need (Minimum Requirements)

• Bachelor’s Degree with 5+ years of experience
• Significant knowledge of the drug development process, Regulatory Affairs and submissions management.
• Understanding of systems and electronic technologies used to support submission and planning activities.
• Excellent written and verbal communication skills, with ability to communicate effectively with all levels of the organization.
• Strong analytical and problem-solving abilities.
• Advanced Microsoft Office Suite skills
• Demonstrated project management skills with the ability to manage multiple concurrent priorities.
  
  

Bonus Points If You Have (Preferred Requirements):

• Advanced degree MA/MBS/M) and 3+ years experience, OR a PHD/PharmD/JD degree
  
  

Work Location Assignment: Remote

Purpose

Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.

Digital Transformation Strategy

One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

Flexibility

We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!

Equal Employment Opportunity

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

Disability Inclusion

Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!

Regulatory Affairs