Manager, Regulatory CMC Strategy
Why Patients Need YouWe'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 AchieveYou will help Pfizer develop and implement chemistry, manufacturing and control (CMC) regulatory strategies for small and large molecule pharmaceuticals and devices 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, manages 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 Manager, you provide guidance to operational teams for managing projects. Your planning skills will help in preparing forecasts for resource requirements, and providing areas of improvement for products, processes or services. Through your comprehensive knowledge of principles, concepts and theories of the discipline, you will also work towards advancing new concepts and methodologies. You will be able to take a leadership role to facilitate agreements between different teams.It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.How You Will Achieve It
Collaborate with departmental and cross-functional colleagues (eg. G-CMC, GRS, GRO, and PGS) to progress Pfizer's business objectives, align expectations and manage planning and monitoring activities to mitigate risks, contribute to global regulatory strategies, deliver expeditious and efficient regulatory submissions for projects across all aspects of drug development or manufacturing lifecycle.
Serve as a Chemistry Manufacturing and Control (CMC) strategist and project leader for projects within the global medical device, combination product and/or IVD portfolio. Partner with other CMC strategists across the broader CMC organisation in providing continued support and regulatory assessments or developing regulatory strategies with some supervision to development teams and lifecycle programs across the MDCP portfolio.
Provide guidance, lead/co-lead projects, manage own time to meet objectives, and plan resource requirements projects across the Department.
Responsible for the development of CMC documentation, coordination and management of global submissions, including the assessment and management of commercial license status, maintenance of product compliance and management of change control.
Contribute to Global Chemistry Manufacturing and Controls projects, initiatives & actions along with prioritizing assigned workload appropriately.
Investigate opportunities for regulatory innovation / promote the use of novel approaches within project team to resolve issues and problems.
Develop effective relationships with local and global internal partners working in medical device and combination products, i.e., Quality Assurance, Pharmaceutical Research and Development including Device Centre of Excellence, Pfizer Global Supply - GTEL, Worldwide Safety and Global Regulatory Business Units, etc.
Leverage both technical and regulatory knowledge, to develop regulatory strategies and mitigate risks.
Execute regulatory policies and operational processes and delivery of high quality regulatory submissions.
Use technical and scientific knowledge to prepare and manage the appropriate analysis of CMC submission documentation.
QualificationsMust-Have
Bachelor's Degree
Min 5+ years of experience in pharmaceutical or medical device industry
Min 3+ years of relevant pharmaceutical/medical device/IVD or combination product development and/or manufacturing experience
Skills and relevant experience that demonstrate CMC (Chemistry Manufacturing and Control) regulatory and quality expertise to prepare regulatory assessments, develop and contribute to global regulatory strategies with assistance from management, for projects across all aspects of product development or manufacturing lifecycle
Demonstrated commitment to scientific and regulatory integrity, quality compliance
Adaptable and self-motivated, able to prioritize effectively with strong problem solving and planning abilities
Excellent planning, organizational and project management skills
Advanced skills in written and verbal communications
Competent working knowledge of computer based systems, such as Microsoft Office, controlled documentation systems
Nice-to-Have
Hands-on CMC authoring experience (investigational, initial registrations or post-approval)
Relevant medical device/IVD/combination product experience
Understanding of the regulatory requirements and development expectations for medical device and combination products including criteria for submission and approval globally
Understanding of medical device design and development expectations and design control requirements.
The candidate should demonstrate a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, oversee and guide the work of other within cross-functional teams 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 environmental 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 (must be within a commutable distance to the sites listed)The annual base salary for this position ranges from $99,900.00 to $166,500.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 15.0% 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 ActPfizer 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 EligibilityPfizer 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.Regulatory Affairs#LI-PFE