Manager, Regulatory CMC Biologics (BioTX) (Secondment - 6 months)
Manager, Regulatory CMC Biologics (BioTX) (Secondment - 6 months)
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1 Vacancy
Job Description
Why Patients Need You
All over the world Pfizer colleagues work together to positively impact health for everyone everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged and have the ability to impact health and lives of millions of people. Pfizer a global leader in the biopharmaceutical industry is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies that significantly improve lives.
What You Will Achieve
As a GRS CMC Manager you will be a key player in Pfizers Global Regulatory Strategy (GRS) Chemistry Manufacturing and Controls (CMC) team. You will have the opportunity to leverage your expertise and skills to drive regulatory strategies and submissions for our products across the lifecycle. Your work will directly impact patients lives by ensuring the quality safety and efficacy of our pharmaceutical products.
How You Will Achieve It
In this role you will be expected to independently prepare regulatory assessments and contribute to global regulatory strategies for projects across all aspects of drug development or manufacturing lifecycle. You will do this by leveraging available guidance and regulations while using your CMC regulatory knowledge and quality expertise.
You will ensure global regulatory conformance and consistency to comply with external regulatory requirements and internal procedures.
You will provide a comprehensive review of regulatory submissions within your remit to ensure consistency with regulatory standards and across related documents.
You will demonstrate regulatory knowledge and experience balanced judgment crisp decision-making and exemplary collaboration while developing regulatory strategies and executing quality regulatory submissions.
You will develop and provide robust regulatory strategies leveraging both technical and regulatory knowledge to mitigate risks.
You will prepare and deliver high quality CMC regulatory submissions and submission management plans for global regulatory agencies.
You will serve as a CMC representative on project teams or may serve as the CMC lead on a program demonstrating the ability to manage project activities assess regulatory risks and support development plans to deliver global regulatory strategies for programs in accordance with regulatory scientific and technical criteria.
You will be expected to maintain submission information in relevant GRS CMC systems track regulatory commitments and timelines for specific projects/products/markets with minimal supervision.
You will have the ability to present and articulate issues for resolution communicate regularly with key stakeholders to ensure alignment provide consultation as a scientific/technical resource for assigned projects mentor and share experience with colleagues.
You will author and/or coordinate NCE/biologic/device development and/or commercial submissions to meet filing requirements for regulatory CMC submissions. You will be expected to coordinate and contribute to responses to Agency queries and to perform quality reviews of regulatory CMC submissions.
You will be expected to prioritize and independently complete the assigned workload appropriately.
You will develop effective relationships with local and global internal partners i.e. R&D PGS QA GRS BUs etc.
You will be expected to execute training-related activities (e.g. compliance-related PX policies) participate in cross-disciplinary forums and learning opportunities and demonstrate and model adherence to all Pfizer behaviors and values.
In addition to project support you will manage and contribute to GRS CMC projects initiatives & actions.
Qualifications
Must-Have
BS/BA (Pharmacy Chemistry Biology or related science) with 4 years of related technical experience or MS with 2 years related technical experience or PhD with 0 years
Experience operating within GMP GLP or GCP related SOPs.
Advanced skills in written & oral communications are mandatory
Computer literacy with Microsoft Office Suite and Documentum-based applications
Skills in document manipulation and electronic document maintenance (e.g. Word Excel Adobe Documentum dossier workflow tools) and other data management tools
Nice-to-Have
At least 3 years of hands-on CMC authoring experience.
Advanced skills in written and oral communication.
Skilled in team dynamics including peer collaboration.
Deep understanding of global CMC regulations guidelines and Health Authority resources.
Proven success in regulatory submissions and strategy.
Excellent project management and communication skills.
Detail-oriented with strong scientific data analysis capabilities.
Demonstrates leadership adaptability and flexibility.
In-depth knowledge of GMP activities and drug development.
Good understanding of regulatory requirements expectations and criteria for global submission approvals.
Demonstrated commitment to scientific and regulatory integrity as well as Quality compliance.
Other Job Details:
Last Date to Apply for Job:July 23 2026
Additional Location Information:Belgium - Puurs Germany - Freiburg Ireland - Cork - Ringaskiddy Ireland - Dublin - Grange Castle Ireland - Kildare - Newbridge Italy - Milan United Kingdom - Sandwich United States - California - South San Francisco United States - Connecticut - Groton United States - Michigan - Kalamazoo United States - Missouri - St. Louis United States - New York - New York City
Eligible for Relocation Package NO
Secondment 6 months
If you are currently in a driving position with a fleet vehicle and this secondment does not require driving as an essential function of the position for12 months or longer you will be required to turn in your fleet vehicle for the duration of the non-driving secondment. Please refer to the Fleet Policy and Procedures document for more information.
There will be no change to your current work location.
Position is considered Flexible and colleagues are expected to comply with Log In For Your Day(LIFYD) requirements at site location (e.g. about 2.5 days a week in office).
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care providers name address and the type of payments or other value received generally for public disclosure. Subject to further legal review and statutory or regulatory clarification which Pfizer intends to pursue reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse your name address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race color religion sex sexual orientation age gender identity or gender expression national origin disability or veteran status. Pfizer also complies with all applicable national state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
Required Experience:
Manager
Employment Type
Full-Time
