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Pfizer Inc. Regulatory Senior Associate Chemistry, Manufacturing, Controls (CMC) in Peapack, New Jersey

ROLE SUMMARY

Assist CMC professionals with the development of CMC regulatory
strategies, submissions and compliance activities for pharmatherapeutic
development programs and commercial products supporting the Essential
Health Business Unit with supervision.

Provide operational global CMC regulatory support and documentation for
assigned projects/products covering initial registrations and
approval/post approval activities of medium complexity/risk. Supports
the assembly of CMC information for submission to global regulatory
agencies and supports CMC strategies with supervision. Maintains and
tracks submission and approval statuses. Assist in regulatory fact
finding for the preparation of CMC information for submission to global
regulatory agencies. Maintain CMC systems and perform data entry.

Assist cross-functional project teams by scheduling meetings, taking
notes and tracking action items independently.

Opportunity to increase level of complexity and independence with
potential career path of global CMC strategist.

RESPONSIBILITIES

Sound understanding of regulatory processes and requirements for defined
market(s) and able to interpret and apply to projects. Aware of external
regulatory environment, including competitor intelligence and regulatory
actions to assist regulatory strategy development. Able to identify
inconsistencies and deficiencies in technical data and escalates to
management for resolution. Assesses scientific opinions in developing
regulatory strategies and documentation. Knowledge of drug development
practice, rules, regulations, and guidelines. Demonstrates a developed
knowledge of key processes, procedures and tools. Maintains compliance
in regulatory systems.

Independently manages projects, makes decisions and executes upon
strategies and plans with minimal oversight from manager. Recommends
solutions and escalates issues with significant business impact where
necessary. Supports team in the development of regulatory strategies to
support registrations. Demonstrates a high level of integrity in
decision making on regulatory issues in line with company values.

Responsible to assist in 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 of moderate
complexity with appropriate supervision.

Actively participates in trade associations.

Fosters a culture in which uncompromising integrity and accountability
is the standard.

Makes decisions to resolve moderately complex problems in standard
situations. Makes decisions within guidelines and policies.

Understands the fundamental business drivers for the company. Uses this
knowledge in own work.

Ability to collaborate effectively across a network of other
stakeholders, partners and customers, to compile high quality CMC inputs
and aiding the compliance of the Pfizer essential pharmatherapeutic
product portfolio. Assists in the development of resolution proposals
for moderate regulatory CMC/information management issues in support of
project/program stakeholders. Displays a willingness to make appropriate
and timely decisions, exhibits sound and accurate judgment.

Ability to develop projects plans to support short-term operational
goals and contribute to the development of global regulatory initiatives
with appropriate supervision.

QUALIFICATIONS

BS or equivalent scientific/engineering/pharmaceutical development
sciences degree required. MS or equivalent
scientific/engineering/pharmaceutical development sciences degree
preferred. Minimum 1-2 years work experience required. PhD or PharmD
with 0-2 years experience would also be considered.

Candidate is required to have a basic understanding of manufacturing /
pharmaceutical sciences / the pharmaceutical industry with an
understanding of drug development/commercial manufacturing of
pharmaceutical products 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 support others in
system use.

The candidate ideally should have experience with effective teamwork,
collaboration, and communication, and demonstrated leadership ability.
Project management along with planning/organizing by prioritizing and
planning work activities and change agility are desirable attributes.

OTHER INFORMATION

Last day to apply: Wednesday, May 23, 2018

Eligible for employee referral bonus

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.

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