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Senior Manager, Regulatory Affairs CMC

4 months ago

Groton, United States Pfizer Full time

Why Patients Need You

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.

What You Will Achieve

You will help Pfizer develop and implement chemistry, manufacturing and controls (CMC) regulatory strategies for small and/or large molecules to meet global regulatory requirements throughout the life cycle. You will participate in a variety of activities, such as, but not limited to, preparing or authoring CMC regulatory investigational, commercial and post-approval submissions, representing the company on communications and in meetings with health authorities, assessing impact of new regulations, managing regulatory documents, etc. You will also be in a position to negotiate with regulatory authority personnel to expedite approval of pending registrations and respond to queries.

As a Senior Manager, your advanced knowledge of the principles and concepts in the area of regulatory affairs and comprehensive knowledge of other disciplines will enable you to lead complex projects across the division. While managing complex project environments, you will be able to anticipate and troubleshoot roadblocks and influence teams to achieve targets. Your ability to develop and manage plans will facilitate achieving objectives, interpreting internal and external business challenges, and recommending best practices for improvements.

It is your leadership skills that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

Develop ideas and lead/co-lead complex projects across division, and develop and manage plans to achieve objectives.

Ensure regulatory conformance & consistency globally in compliance with external regulatory requirements and internal quality procedures.

Investigate opportunities for regulatory innovation / promote the use of novel approaches within project teams to resolve issues and problems.

Develop effective relationships with local & global internal partners, i.e., Research and Development, Pfizer Global Supply, Global Regulatory Sciences, Business Units, etc.

Serve as a Global Regulatory Sciences Chemistry Manufacturing and Controls (CMC) strategist and project leader, providing regulatory assessments and developing regulatory strategies with minimal supervision.

Lead the preparation of CMC information for submission to regulatory agencies, generate CMC strategies, assess risks and develop contingency plans, including major, complex applications.

Execute training-related activities (e.g. compliance-related, HR policies) and individual development plans, participate in cross-disciplinary forums & learning opportunities.

Demonstrate and model adherence to all Pfizer behaviors & values, embrace and comply with Global Chemistry Manufacturing and Controls Principles of Integrity.

Serve as a technical and scientific resource within own work group and provide guidance for completion of difficult and complex projects.

Qualifications

Must-Have

Bachelor's Degree

7+ years of experience in the pharmaceutical industry

3+ years of pharmaceutical regulatory experience

Drug substance or drug product development or manufacturing technical support experience

Experience in regulatory Chemistry Manufacturing and Controls (CMC) or regulatory expertise in pharmaceutical science development and/or manufacturing

Solid understanding of the regulatory requirements and expectation, criteria for submission and approval globally, and experience with regulatory authority interactions

Demonstrated commitment and dedication to scientific & regulatory integrity and to quality compliance

Ability to learn and navigate tracking/change control systems, and willingness to train and support others in system use

Adaptable and self-motivated, able to prioritize effectively with strong problem solving and planning abilities

Strong interpersonal and leadership skills

Competent working knowledge of computer-based systems, such as Microsoft Office and controlled documentation systems

Nice-to-Have

Master's degree

Experience engaging in the external regulatory and pharmaceutical environment

2+ years of hands-on CMC authoring experience (investigational, initial registrations or post-approval)

3+ years of management/supervisory experience

Experience managing projects

Breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

PHYSICAL/MENTAL REQUIREMENTS

This position/role works in an office where physical requirements are consistent with typical office functions & activities. This position must also be affiliated with a Pfizer facility.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

This role is expected to travel domestically & internationally as required.

The external environment is dynamic & may require flexibility outside of conventional working hours and on weekends to support project timelines.

PHYSICAL/MENTAL REQUIREMENTS

This position/role works in an office where physical requirements are consistent with typical office functions & activities. This position must also be affiliated with a Pfizer facility.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

This role is expected to travel domestically & internationally as required. The external environment is dynamic & may require flexibility outside of conventional working hours and on weekends to support project timelines.


Work Location Assignment: On premise


The annual base salary for this position ranges from $131,200.00 to $218,600.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 17.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

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 provider’s 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.

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