Clinical Trial Submission Senior 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
As a Senior Manager Submissions Strategy, you will be responsible for directing 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 lead complex projects division-wide, leveraging your expertise to develop strategic plans, resolve challenges, and drive teams towards achieving objectives.

• Provide strategic direction to teams on regulatory logistics and serve as a regulatory operational liaison on the project team throughout the product lifecycle
• Drive global submission management activities for assigned assets and provide guidance for related activities.
• Partner with product teams and/or third-party partners to manage required regulatory activities.
• Promote the use of Document Management and Archival systems and standard document authoring.
• Drive communication and propose refinements for the emerging markets through collaboration with stakeholders.
• Lead the interpretation of regulatory guidelines and requirements to produce business processes and ensure implementation.
• Partner with key stakeholders to ensure quality and consistency of processes and maintain compliance with regulatory obligations.
• Serve as a source of innovative ideas, seeking and developing efficiencies within the Submissions process.
• Drive and implement strategies for operational excellence through interaction with global regulatory leaders and product teams.

Here Is What You Need (Minimum Requirements)

• BA/BS with 6+ years of experience, or MBA/MS with 5 + years of experience, or PhD/JD with 1+ years of experience, or MD/DVM with 0+ years of experience.
• Extensive knowledge in drug development, Regulatory Affairs, and submission management.
• Advanced Microsoft Office Suite skills and strong competency with tools.
• Strong understanding of regulatory submission processes and requirements.
• Excellent analytical and problem-solving abilities.
• Effective communication skills, both written and verbal.

Bonus Points If You Have (Preferred Requirements)

• Experience in the pharmaceutical or biotechnology industry with advanced knowledge of regulatory guidelines and compliance standards.
• Strong understanding of statistical modeling and data analytic methodologies.
• Demonstrated knowledge of product lines, processes, and associated technologies.
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance

Our Offer:

• Work Location Assignment: 100% Remote
• Salary range minimum for an annual base salary:
  249 750 PLN.
• Anual bonus: 20%
• Benefits: company car, Medicover, Multisport, insurance at UNIQUA, provate pension plan

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!
Pursuant to Article 24(6) of the Act of June 24, 2024 on the protection of whistleblowers, Pfizer Polska Sp. z o.o. and Pfizer Trading Polska Sp. z o.o. declare that they have adopted a joint internal reporting procedure, which, in accordance with the provisions of the aforementioned Act, is also available to persons applying for employment on the basis of an employment relationship or other legal relationship constituting the basis for providing work or services or performing functions. The content of the procedure is made available upon request sent to the contact person or to the email address [email protected].
Regulatory Affairs