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Senior Associate Reg CMC

Employer
Pfizer
Location
Lake Forest, Illinois, United States;Sanford, North Carolina, United States;Collegeville, Pennsylvania, United States;Peapack, New Jersey, United States;
Salary
Competitive
Closing date
May 19, 2022

View more

Discipline
Other, Legal/Regulatory Affairs
Position Type
Full Time
Organization Type
Pharma
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ROLE SUMMARY

The GCMC Senior CMC Associate possesses moderate CMC regulatory knowledge and quality expertise to prepare regulatory assessments, develop & contribute to global regulatory strategies with assistance from management for projects across all aspects of drug development or manufacturing lifecycle.

The GCMC Senior CMC Associate is accountable for:
  • Continued pursuit of developing an understanding of regulatory conformance & compliance with external regulatory requirements & internal quality procedures.
  • Development and provision of robust regulatory strategies, leveraging both technical & regulatory knowledge, to mitigate risks.
  • Delivery of high quality regulatory submissions.
  • Execution of regulatory policies and operational processes.
  • Actively contribute to cross-functional and strategic initiatives, novel concepts and solutions to address gaps and mitigate risks and improve conformance.


ROLE RESPONSIBILITIES

The GCMC Senior CMC Associate is responsible for:
  • Developing effective relationships with local & global internal and external partners, i.e., R&D (PTx, BTx, PCH), PGS, WSR, BU's, etc.,
  • Execute training related activities (e.g. compliance-related, HR policies) & individual development plans, participate in cross-disciplinary forums & learning opportunities,
  • Engage in Straight Talk & Listen exchanges, demonstrate & model adherence to all Pfizer behaviors & values, embrace & comply with GCMC Principles of Integrity.
  • Ensuring all regulatory activities for assigned products is executed effectively & efficiently in compliance with external regulatory requirements & internal quality procedures.
  • Contribute to GCMC projects, initiatives & actions.
  • Demonstrated commitment & dedication to scientific & regulatory integrity & quality compliance.
  • Prioritizing assigned workload appropriately.
  • Demonstrating ability to present and articulate issues for resolution and execute as a scientific/technical resource for assigned projects.
  • Serving as CMC representative on a core project(s) demonstrating ability to manage project activities, assess regulatory risks & development plans to develop global regulatory strategies for programs in accordance with regulatory, scientific & technical criteria.


QUALIFICATIONS

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:
  • Bachelor's degree or equivalent/graduate degree preferred in a pharmaceutical (Biology, Chemistry, Chemical Engineering, Pharmacy or related science)

Experience :
  • Technical discipline with 3-+ years of experience in the pharmaceutical industry with relevant technical experience (QA, Technical Services, Operations, Manufacturing or R&D) and 2+ 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 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 in development & commercial activities and cGMP's is required.
  • An understanding of regulatory requirements & expectations and criteria for submission & approval globally.
  • Demonstrated commitment & dedication to scientific & regulatory integrity & quality compliance.
  • Experience engaging in the external regulatory & pharmaceutical environment is preferred.


Desired Competencies:

Decision Making

• Acts Decisively

Risk Mgt

• Ability to recognize risks across projects and programs.

• Manages regulatory risks & ambiguous situations under direct supervision.

Scientific & Regulatory Leadership

• Ability to contribute to projects or team initiatives to support short-term operational goals.

• Ability to influence at the work group project team level.

Teamwork/ Collaboration

• Ability to contribute to effective teams & implement change

Communication

• Communication & Negotiation skills

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. This position must also be affiliated with a Pfizer facility.


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
  • This role is expected to travel domestically & internationally as required.
  • The external environment is dynamic & may require flexibility outside of conventional working hours and on weekends to support project timelines.


This description indicates the general nature and level of work expected. It is not designed to cover or contain a comprehensive listing of activities or responsibilities required of the incumbent. Incumbent may be asked to perform other duties as required.

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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

#LI-PFE
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