1+ months

Manager, Regulatory Affairs CMC, Upjohn

Pfizer
Collegeville, PA 19426
**ROLE SUMMARY**

The Manager, Regulatory Affairs CMC, Upjohn, possesses CMC regulatory knowledge and quality expertise to independently prepare regulatory assessments & contribute to global regulatory strategies for projects across all aspects of drug development or manufacturing lifecycle and works to support the Upjohn product portfolio.



The Manager, Regulatory Affairs CMC, Upjohn is accountable for:



+ Ensuring regulatory conformance & consistency globally and in compliance with external regulatory requirements & internal quality procedures.

+ Demonstrating regulatory knowledge & experience, balanced judgment, crisp decision-making, exemplary collaboration & business acumen , i.e., regulatory strategy development, regulatory submission quality, investigations, review of policy & quality standards

+ Development and provision of robust regulatory strategies, leveraging both technical & regulatory knowledge, to mitigate risks.

+ Preparation & Delivery of high quality CMC regulatory submissions & submission management plans for global regulatory agencies.

+ Execution of regulatory policies and implementation of policies and operational processes for delivering the product portfolio.



**ROLE RESPONSIBILITIES**



The Manager, Regulatory Affairs CMC, Upjohn is responsible for:



+ Serving as CMC representative on a core project(s), managing project activities, assessing regulatory risks & development plans to develop global regulatory strategies for programs in accordance with regulatory, scientific & technical criteria.

+ Managing regulatory issues, maintaining submission information in relevant CMC systems, tracking regulatory commitments & timelines for specific projects/products/markets with minimal supervision.

+ Presenting and articulating issues for resolution, communicating regularly with key stakeholders to ensure alignment, providing consultation as a scientific/technical resource for assigned projects, mentoring and sharing experience with colleagues.

+ Authoring and/or coordinating CMC activities for new registrations, post approval changes, renewals, annual reports and line extensions to meet filing requirements. Coordinating & contributing to responses to Agency queries and performing quality review of regulatory CMC submissions.

+ Serving as a technical and scientific resource and providing guidance for completion of difficult and complex projects.

+ Prioritizing & independently completing assigned workload appropriately.

+ Developing effective relationships with local & global internal partners, i.e., R&D, PGS, Country Regulatory Leads, other CMC lines.

+ Developing relationships with regulatory authorities to improve Pfizer's regulatory success.

+ Executing training related activities (e.g. compliance-related, HR policies) & individual development plans, participating in cross-disciplinary forums & learning opportunities, engaging in Straight Talk & Listen exchanges, demonstrating & modeling adherence to all Pfizer behaviors & values, embracing & complying with Principles of Integrity.

+ Managing and contributing to CMC-related projects, initiatives & actions.

+ Participating, as required, in pharmaceutical industry conferences or serving externally as a representative to pharmaceutical trade group advisory committees relevant to CMC functions.

+ Mentoring colleagues within focused area of expertise.



**BASIC QUALIFICATIONS**



**Education and Experience:**



+ Bachelor's degree or equivalent/graduate degree preferred in a pharmaceutical (Biology, Chemistry, Pharmacy or related science) &/or technical discipline

+ 6+ years of experience in the pharmaceutical industry with relevant technical experience (QA, Technical Services, Operations, Manufacturing or R&D)

+ 3+ years pharmaceutical regulatory experience



**PREFERRED QUALIFICATIONS**



+ Minimum of 2+ years of hands-on CMC authoring experience (initial registrations or post-approval variations) is preferred.

+ Advanced skills in written & oral communications

+ Computer literacy with Microsoft Office Suite and Documentum-based applications highly desired

+ Prior experience managing projects is preferred.



**Technical and/or other job-related skills:**



+ Sufficient level of knowledge and solid understanding of the development & commercial activities and cGMP's required to assess technical, scientific & regulatory merits of CMC information, commitments and data to lead teams and/or project(s).

+ Applies technical, functional, and industry knowledge to shape strategic direction of assigned project(s), reduce regulatory burden & improve regulatory flexibility commensurate with business needs.

+ An understanding of regulatory requirements & expectations, criteria for submission & approval globally & experience of interactions with regulatory authorities for projects.

+ Updates, interprets, and applies global & regional CMC guidelines. Ability to contribute to global regulatory strategies by proactively discussing with partners.

+ May participate in limited interactions with regulatory authorities to respond to requests either directly or in conjunction with Regulatory Affairs personnel.

+ Demonstrated commitment & dedication to scientific & regulatory integrity & quality compliance.

+ Experience engaging in the external regulatory & pharmaceutical environment is preferred.

+ Emerging awareness of new scientific or manufacturing technology.

+ Possesses sound understanding of business expectations across divisions

+ May serve as Subject Matter Expert in specific relevant disciplines or as a recognized resource for specific pharmaceutical science projects and/or specialized expert in specific regulatory domains

+ Demonstrates sound understanding and advanced knowledge of the principles, practices and concepts of a regulatory CMC/ policy/ publishing disciplines and a working knowledge of the principles, practices, concepts and operations in other relevant disciplines.



**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 ENVIRONMENT REQUIREMENTS**



+ Minimal travel may be required.

+ Owing to the global nature of the position, occasional work outside of conventional working hours may be needed.



**ORGANIZATIONAL RELATIONSHIPS**



+ PGS and R&D functional managers

+ Country and regional regulatory managers

+ Regulatory authority reviewers, administrators &/or inspectors.

+ External partners, CMOs, CROs, consultant & contracted resources.



**Other Job Details:**



+ **Last Date to Apply for Job: May 8, 2020**

+ Additional Location Information: Kalamazoo, MI; Peapack, NJ; Collegeville, PA; Groton, CT . This position can work remotely within North America and Europe

+ Eligible for Employee Referral Bonus



\#LI-PFE



**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.



**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

Categories

Posted: 2020-04-27 Expires: 2020-08-01

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Manager, Regulatory Affairs CMC, Upjohn

Pfizer
Collegeville, PA 19426

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