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Regulatory Senior Associate Chemistry, Manufacturing, Controls (CMC)

Employer
Pfizer
Location
Groton, Connecticut
Salary
Competitive
Closing date
Mar 4, 2021

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Why Patients Need You

We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines.

What You Will Achieve

You will help Pfizer develop and implement chemistry, manufacturing and control (CMC) regulatory strategies, submissions and compliance activities for pharma therapeutic development programs and commercial products supporting the PBG Hospital 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. You will participate in a variety of activities, such as, but not limited to, preparing or authoring CMC regulatory investigational, commercial and post approval submissions, representing the company on communications and in meetings with health authorities, assessing impact of new regulations, manages regulatory documents, etc.

As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams. It is your hard work and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe.

Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage,joy, equity and excellence. Ourbreakthrough culture lends itself to our dedication to transforming millions of lives.We value every employee and throughout their careerencourage them to grow, developand express their viewsfreely.

How You Will Achieve It
  • Contribute to the completion of projects, manage own time to meet agreed targets and develop plans for short-term work activities on own projects within a work team.
  • Ensure compliance of the team to the submission standards, procedures and policies framed by Global Regulatory Affairs.
  • 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.
  • 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.
  • 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.
  • Actively participates in trade associations.
  • Fosters a culture in which uncompromising integrity and accountability is the standard.
  • 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.
  • 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

Must-Have
  • BS or equivalent scientific/engineering/pharmaceutical development sciences degree required. MS or equivalent scientific/ engineering/ pharmaceutical development sciences degree preferred.
  • 3+ years of experience
  • 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.


Nice-to-Have
  • Project management along with planning/organizing by prioritizing and planning work activities and change agility are desirable attributes.


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
  • Limited travel.


Other Job Details:
  • Last Date to Apply for Job: 3/9/21
  • Additional Locations: Kalamazoo, MI, Peapack, NJ, Collegeville, PA or Newbridge, Ireland
  • Eligible for Employee Referral Bonus: YES


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

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