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Global Regulatory Affairs Branded Pharmaceutical CMC


Peapack, NJ
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Job Details

Job Title Global Regulatory Affairs Branded Pharmaceutical CMC

JobID 1048931-1852

Location: Peapack, NJ

Description *About Pfizer*

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.

*Role Description*

Supporting the Pfizer Essential Health (PEH) Business Unit, the Regulatory Affairs Branded Pharmaceutical CMC - Device is a recognized CMC expert serving as primary project leader responsible for the development of CMC regulatory strategies, submissions and compliance activities for pharmatherapeutic development programs and commercial products, including drug delivery and dosing devices as well as combination products.Reporting to the CMC Team Lead, s/he will provide and drive strategic and operational global CMC regulatory direction and documentation for assigned projects/products covering initial registrations and approval/post approval activities with focus on delivery and dosing device strategy; and leads the preparation of CMC information for submission to global regulatory agencies, generates and drives CMC strategies, assesses risks and develops contingency/mitigation plans. S/he acts as the global CMC representative within cross-functional project teams, involving the interpretation of regulations and guidelines, including delivery and dosing devices, and the assessment of global implications for strategic CMC decisions; supports due diligence and business development projects; and is primarily accountable for assigned CMC programs, managing daily delivery of regulatory and strategic activities, including initial registrations and post-approval changes, portfolio growth initiatives, due diligence and ongoing compliance of commercial products including drug delivery devices in the portfolio.S/he 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; and contributes to the development of internal policies, processes and procedures supporting the progression and maintenance of the Pfizer established pharmatherapeutic portfolio as appropriate.This role could be located a Pfizer's Peapack, NJ office or New York/HQ, north suburban Chicago/Lake Forest, IL; Groton, CT; Collegeville, PA; Sandwich/Walton Oaks, UK; Dublin/Cork, Ireland. No relocation.


Serve as the primary CMC strategist and/or project lead for projects within the Pfizer Essential Health portfolio, providing regulatory assessments and developing regulatory strategies independently, including for drug delivery and dosing devices as well as combination products.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.Interpret CMC regulatory requirements for pharmatherapeutics, delivery and dosing devices and combination products; develops strategies (including novel approaches), assess risks and develops contingency proposals. Use technical and scientific knowledge to conduct the appropriate analysis of CMC submission documentation. Look 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's Essential Health 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.Collaborates across Essential Health Global Regulatory, global CMC and functional activities in a matrix environment, with globally located cross-functional project teams including representatives from diverse disciplines within the Pfizer Essential Health 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.Expected travel (25%) to external (trade association or agency) or internal meetings as required.


Bachelor's Degree/Master's Degree, PhD Degree or equivalent scientific/engineering/pharmaceutical development sciences degree.Must have a minimum of 7-10 years relevant pharmaceutical development, QA/QC, and/or manufacturing experience, with focus on drug delivery and dosing devices as well as combination products. Must have a minimum of 3 years drug substance or drug product development or manufacturing technical support experience. Must have a minimum of 3 - 5 years Regulatory CMC experience with drug delivery devices such as self-injectors, intrauterine devices (IUDs), etc. and combination products. Must have diverse experience with sterile products, sponges, films, patches, syringes, intrauterine devices, spoons, cups, etc..A demonstrated regulatory CMC professional or an individual with regulatory expertise in pharmaceutical science development or manufacturing and/or specific regulatory domain with focus on drug delivery and dosing devices as well as combination products. Ability to interpret and apply global / regional CMC regulatory policies and requirements for assigned portfolio, including devices.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 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. 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.

*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.

*Global Regulatory Affairs Branded Pharmaceutical CMC*
*Peapack, New Jersey*

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