Pfizer Regulatory Affairs Senior Manager CMC in Peapack, New Jersey
A career at Pfizer offers opportunity, ownership and impact.
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 the ability to impact the 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 to patients that significantly improve their lives.
Experienced CMC professional serving as project leader responsible for the development of initial CMC regulatory strategies, submissions and compliance activities for pharmatherapeutic development programs and commercial products supporting the Essential Health Business Unit 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 initial preparation of CMC information for submission to global regulatory agencies, generates and drives CMC strategies, assesses risks and develops contingency/mitigation plans with supervision.
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 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 with minimal supervision to resolve issues and manage regulatory risks and ambiguous situations within project teams. Initial investigation of opportunities for regulatory innovation / promote the use of novel approaches within project team to resolve issues and problems with supervision.
Serve as a CMC strategist and project leader for projects within the global Essential Health portfolio, providing regulatory assessments and developing regulatory strategies with minimal supervision.
Act as the global CMC representative, or contributes support to 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, 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 initial 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 with minimal supervision.
This role could be located a Pfizer's Peapack, NJ office; north suburban Chicago/Lake Forest, IL; Kalamazoo, MI; Groton, CT; Collegeville, PA; Sandwich/Walton Oaks, UK; Dublin/Cork, Ireland. Local candidates only. No relocation.
BS/MS/PhD or equivalent scientific/engineering/pharmaceutical development sciences degree. Must have a minimum of 3-5 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. Experience with diverse dosage forms, particularly sterile products, is desirable.
An experienced 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 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.
General office based activities, requiring the operation of telephone and computer systems. Occasional business travel.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Occasional business travel.
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.
Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.
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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 the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.