Regulatory Affairs Senior Manager CMC

ROLE SUMMARY

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. We value every employee and throughout their career encourage them to grow, develop and express their views freely.

• Experienced CMC professional serving as project leader responsible for the development of CMC regulatory strategies, submissions and compliance activities for pharmatherapeutic development programs and commercial products supporting the Pfizer Biopharmaceuticals Group Hospital Category Business Unit, specifically Anti-Infectives, independently or with minimal supervision.
• Provide and drive strategic and operational global CMC regulatory direction and documentation for assigned projects/products covering initial registrations and approval/post approval activities. Leads the preparation of CMC information for submission to global regulatory agencies, generates and drives CMC strategies, assesses risks and develops contingency/mitigation plans.
• Acts as the global CMC representative within cross-functional project teams, involving the interpretation of regulations and guidelines and the assessment of global implications for strategic CMC decisions with minimal supervision.
• Accountable for assigned CMC programs, managing daily delivery of regulatory and strategic activities, including initial registrations and post-approval changes, portfolio growth initiatives, and ongoing compliance of commercial products in the portfolio.
• May represent CMC during interactions with regulatory agencies and external partners either directly or in conjunction with Regulatory Affairs.
• Operate independently to resolve issues and manage regulatory risks and ambiguous situations within project teams. Investigates opportunities for regulatory innovation / promote the use of novel approaches within project team to resolve issues and problems.
• Contributes to the development of internal policies, processes and procedures supporting the progression and maintenance of the Pfizer established pharmatherapeutic portfolio as appropriate.

ROLE RESPONSIBILITIES

• Serve as a CMC strategist and project leader for projects within the global Pfizer Biopharmaceuticals Group Hospital Category Anti-Infectives portfolio, providing regulatory assessments and developing regulatory strategies independently or with minimal supervision.
• Act as the global CMC representative within cross-functional project teams.
• Accountable for assigned projects and activities, completing work within assigned product portfolio, work group/project teams, for multiple projects with minimal supervision.
• Interpret CMC regulatory requirements for human health prescription products, develops strategies (including novel approaches), assess risks and develops contingency proposals with minimal supervision.
• Uses technical and scientific knowledge to conduct the appropriate analysis of CMC submission documentation.
• Looks for ways to improve and promote quality and demonstrates accuracy and thoroughness.
• Responsible for the authoring 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.
• Ability to collaborate effectively across a network of other stakeholders, partners and customers, to deliver high quality CMC submissions and ensuring the compliance of the Pfizer essential pharmatherapeutic portfolio.
• Develops resolution proposals for regulatory CMC/information management issues with project/program stakeholders.
• Displays a willingness to make decisions, exhibits sound and accurate judgment and makes timely decisions.
• Able to develop and/or lead projects or team initiatives to support short-term operational goals and contribute to the development of global regulatory initiatives.

ORGANIZATIONAL RELATIONSHIPS

• Collaborates across global CMC and functional activities in a matrix environment, with globally located cross-functional project teams including representatives from diverse disciplines within the Pfizer Biopharmaceuticals Group Global Product Development organization and Pfizer Global Supply.
• May represent CMC in interactions with regulatory agencies and/or external partners (either directly or in conjunction with Regulatory Affairs Department).
• May participate in pharmaceutical industry initiatives and support the development of Pfizer positions to external regulatory policies.

QUALIFICATIONS

BASIC QUALIFICATIONS

• Candidate demonstrates a 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.
• BS/MS/PhD or equivalent scientific/engineering/pharmaceutical development sciences degree.
• Must have a minimum of 5-7 years relevant pharmaceutical development, QA/QC, and/or manufacturing experience.
• Must have a minimum of 3 years drug substance or drug product development or manufacturing technical support experience.
• A demonstrated regulatory CMC professional or an individual with regulatory expertise in pharmaceutical science development or manufacturing and/or specific regulatory domain.
• Ability to interpret and apply global / regional CMC regulatory policies and requirements for assigned portfolio.
• Candidate is required to have a sound understanding and advanced functional knowledge of manufacturing / pharmaceutical sciences / the pharmaceutical industry with a clear understanding of drug development/commercial manufacturing of biologics pharmaceutical products, including technical and scientific understanding of pharmaceutical drug development with technical writing skills.
• Competent working knowledge of computer based systems such as Microsoft Office, controlled documentation systems (e.g. Documentum).
• Ability to learn and navigate tracking/change control systems, compliant and consistent use of systems (including GMP validated systems) and willingness to train and support others in system use.
• The candidate is required to have a clear track record of effective teamwork, collaboration, and communication, and also demonstrated leadership ability in a cross-functional matrix team environment.
• Product management along with planning/organizing by prioritizing and planning work activities and change agility are also essential attributes.

PREFERRED QUALIFICATIONS

• Experience with diverse dosage forms, particularly sterile products, is desirable.

CORE COMPETENCIES

• Acts Decisively, Self-Awareness, Seizes Accountability & Builds Effective Teams

PHYSICAL/MENTAL REQUIREMENTS

• Normal office based and needs to be able to travel on public transport, including international.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Travel to external (trade association or agency) or internal meetings as required.

Other Job Details:

• Last Date to Apply for Job: 3/9/21
• Additional Locations: Kalamazoo, MI, Peapack, NJ, Collegeville, PA or Newbridge, Ireland
• Eligible for Employee Referral Bonus: YES

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Sunshine Act

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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.

Regulatory Affairs

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