Pfizer Off Campus Recruitment Drive 2022 | Hiring Freshers for the role of Interns for Chennai Location

Pfizer Off Campus Recruitment Drive 2022 | Hiring Freshers for the role of Interns for Chennai Location

Job Title: Intern

Role:

  • Contribute to the completion of project milestones and organize own work to meet project task deadlines.
  • Ensure compliance of the team to the submission standards, procedures and policies framed by Global Regulatory Affairs.
  • Responsible for the preparation and finalization of Global Regulatory Strategy Documents (GRSD), Comparative Toxicogenomics Database (CTD) sections of supplements / variations for Lifecycle Management (LCM) submissions and ensure effective data presentation and quality, by self or under guidance.
  • Provide regulatory support to the cross functional teams for the assigned products, participates and provides inputs in technical reviews and strategic discussions on regulatory submissions.
  • Provide regulatory inputs for the approval of promotional materials following applicable regulatory requirement, Pfizer policies, procedures, and practices.
  • Identify and assess regulatory risks associated with assigned projects and timely communication to the team to quickly mitigate the risks.
  • Liaise with key stakeholders to ensure the filing strategies are defined and executed, and Board of Health (BoH) requirements are met, ensuring a submission ready dossier.
  • Ensure commitments made to health authorities are entered into tracking systems and are tracked to closure.
  • Manage continuous improvement of selected processes relating to Human health submissions and selected drug and non-drug specific projects and related activities.
  • Ensure timely approval according to product registration plan.
  • Maintain the required regulatory databases to ensure compliance.
  • Keep abreast of the external regulatory environment, including competitor intelligence, local product and international regulatory and commercial strategies.

Qualifications:

Mandatory:

  • Bachelor's Degree
  • Proven ability to manage complex regulatory or drug development issues
  • Knowledge of the regulations and guidelines in the various markets
  • Strong relationship with the local health agency and other relevant stakeholders and pro-actively manages issues with key external stakeholders
  • Good skills on communication, collaboration, negotiation and problem solving
  • Fluent in English, written and spoken
  • Computer literacy and ability to learn new systems

Optional:

  • Knowledge of regulatory processes and documents, knowledge of therapeutic areas
  • Thinks strategically with good project management skills.

Locations: India - Chennai

Work Location Assignment: On Premise

Job Type: Full time


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