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Regulatory Affairs Sr Manager CMC, Medical Devices

Pfizer


Location:
Kalamazoo, MI
Date:
04/05/2018
2018-04-052018-05-13
Pfizer
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Job Details

**Role Summary**







+ 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, including device and combination products, supporting the Essential Health Business Unit 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 and device/combination product portfolio as appropriate.







**The major duties and responsibilities will include, but are not limited to:**







+ Serve as a CMC strategist and project leader for projects within the global Essential Health 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 and device/combination product 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.







**Qualifications:**







+ 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, including with device and combination products.



+ 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 pharmaceutical and device/combination 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.



+ Experience with diverse dosage forms, particularly including drug delivery and dosing devices as well as combination products, is desirable.







**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.







**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.







**Other Information**



Last day to apply: Wednesday, April 25, 2018







Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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