1+ months

Senior Manager, Regulatory CMC Strategy, Upjohn

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The Senior Manager, Regulatory CMC Strategy, Upjohn possesses CMC regulatory knowledge and quality expertise to independently prepare regulatory assessments & contribute to local (China) & regional regulatory strategies for projects across all aspects of drug development or manufacturing lifecycle and works to support the Upjohn portfolio.

The Senior Manager, Regulatory CMC Strategy, Upjohn is accountable for:

+ Ensuring regulatory conformance & consistency globally 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 local & regional regulatory agencies.

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

+ Managing a small team of colleagues


In order of importance, indicate the primary responsibilities critical to the performance of the role. It is recommended not to list actual tasks but focus on 5-8 essential responsibilities that highlight accountability and level of judgment required.

The Senior Manager, Regulatory CMC Strategy, Upjohn is responsible for:

+ Serving as CMC representative on a core project(s), managing project activities, assessing regulatory risks & development plans to develop Chinese 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, UGS, 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.

+ Providing guidance & direction to a small team of direct reports, managing resources & resource capacity along with prioritizing workload appropriately.

+ Accomplishing performance-management & training related activities, encouraging & supporting a healthy work/life balance, supporting roll-out of HR policies, recruiting & hiring vacancies, providing guidance & facilitating opportunities for talent development, encouraging colleague participation in cross-disciplinary forums & learning opportunities, engaging colleagues in Straight Talk & Listen exchanges, demonstrating & modeling adherence to all Pfizer behaviors & values, embracing & complying with Principles of Integrity.

+ Presenting and articulating issues for resolution, communicating regularly with key stakeholders to ensure alignment, providing consultation as a scientific/technical resource within the department/cross-functional and therapeutic teams for assigned projects, mentoring and sharing experience with colleagues.

+ Managing, leading and contributing significantly to Upjohn projects and initiatives within cross-functional project teams.


Indicate qualifications that are job related, consistent with business necessity and necessary for the performance of an essential function of this role including: education/licenses/certifications, relevant experience (where legally permissible), technical and/or other job-related skills.

**Education & Experience:**

+ Bachelor's degree or equivalent/graduate degree preferred in a pharmaceutical (Biology, Chemistry, Pharmacy or related science) &/or technical discipline with 8+ years of experience in the pharmaceutical industry with relevant technical experience (QA, Technical Services, Operations, Manufacturing or R&D) and 3+ years pharmaceutical regulatory experience.

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

+ 2+ years management & supervisory experience of staff and technical projects

+ Advanced skills in written & oral communications (Chinese and English) are mandatory

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

**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 locally (China) and regionally, & experience of interactions with regulatory authorities for projects.

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

+ May participate in 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** (not all roles will have physical or mental requirements)

Indicate any physical or mental requirements necessary for the performance of an essential function of this particular role. Requirements should be unique to the work being performed in this role and consistent with business necessity. Examples: Lifting, sitting, standing, walking, bending, ability to perform mathematical calculations and ability to perform complex data analysis.

+ This position/role works in an office where physical requirements are consistent with typical office functions & activities.


(not all roles will have non-standard work schedule travel, or environment requirements)

Include any work schedule, travel or environment requirements necessary for the performance of the role. Types of requirements might include ability to work particular hours (shift, overtime), travel or adhere to safe work practices and procedures such as aseptic gowning. Any criteria indicated must be job-related, consistent with business necessity, and specific to this role.

+ Minimal travel may be required.

+ Owing to the need to interact with the broader, global team, occasional work outside of conventional working hours may be needed.

**CORE COMPETENCIES** (Applicable only for the Senior Leader or Manager roles and global job levels indicated below)

Select the 3-5 competencies most critical for the successful performance of this role from the appropriate Pfizer Core Competency set below. Please only choose selections from appropriate section.

**Senior Leader**

Global Job Level J120+ (Vice President, US Grades 21+)


All roles Global Job Level J090+ (Sr. Manager-Sr. Director); and People (Colleague) Manager roles J060+ (Sr. Associate/Scientist US Grades 7-20)

Anticipates Customer & Market Needs

Grows Leaders

Demonstrates Business Acumen

Leads Change

Strategic & Innovative Thinking

Builds Change Agile Organizations

Acts Decisively


Acts Decisively


Seizes Accountability

Commits to "One Pfizer"

Seizes Accountability

Insight, Influence & Inclusion

Holds People Accountable

Builds Effective Teams

Holds People Accountable

Commits to "One Pfizer"

Grows Others


Provide the primary groups or key role(s) that this role will have interaction with as a regular part of the role responsibilities. Include any external interactions as appropriate.

+ UGS and R&D functional managers

+ Country and regional regulatory managers

+ Regulatory authority reviewers, administrators &/or inspectors.

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


**Financial Accountability**

Indicate the Average Budget or Revenue accountability, as applicable.

+ Not applicable


Indicate the typical number of Colleagues managed; include direct & indirect reports and matrix responsibility. Note if direct reports are people managers or individual contributors. Indicate additional resources (i.e. contingent workers) managed, as applicable.

+ **3 colleagues at the Manager level (individual contributors)**

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

Regulatory Affairs
Posted: 2020-02-06 Expires: 2020-04-09

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Senior Manager, Regulatory CMC Strategy, Upjohn


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