Summarize the primary purpose & key accountabilities of the role, including geographical scope (i.e. Global vs. Country/Region). Summary should be concise and include strategic information that would attract candidates to the role. It may be helpful to complete this section after you have finished the other sections of the document.
The 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 product portfolio.
The Manager, Regulatory CMC Strategy, Upjohn is accountable for:
- Ensuring regulatory conformance & consistency to local & regional 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.
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 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 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, line extensions, authorized generic filings and all license maintenance activities. 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.
- Mentoring colleagues within focused area of expertise.
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 and Experience:
- Bachelor’s degree in a pharmaceutical (Biology, Chemistry, Pharmacy or related science) &/or technical discipline with 6+ 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.
- Advanced skills in written & oral communications (Chinese and English) are mandatory.
- 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 locally (China) and regionally, and experience of interactions with regulatory authorities for projects.
- Updates, interprets, and applies local CMC guidelines. Ability to contribute to local/regional 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 (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.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
(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 global departmental footprint, 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.
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.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.