Pfizer Healthcare Hiring for Regulatory Affairs Department

Recruitments for Pfizer Healthcare India Pvt Ltd-2021. Hiring Master s / Bachelor s degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences for Regulatory Affairs departments. Full details are provided below.

Vacancy Details :

Name of the Company: Pfizer Healthcare India Ltd

Qualification:Master s / Bachelor s degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences.

Department: Regulatory Affairs

Post Name: Team Head

Experience Needed: 7 to 14 years

Job Location: Chennai

Vacancies: NA

Salary Package: NA

Contact No: NA

Pfizer Ltd Notifications

Job Summary

  • Committed to quality and excellence in compliance and conformance
  • Accountable for maintaining the corporate change and dossier management system (PDM) regarding the status of regulatory CMC submissions with global health authorities per internal SOPs and policies.
  • Work in collaboration with regulatory colleagues to ensure compliance and deliver efficiencies in the regulatory submission process.

JOB RESPONSIBILITIES :

  • Committed to quality and excellence in compliance and conformance
  • Accountable for maintaining the corporate change and dossier management system (PDM) with respect to the HA status of regulatory CMC submissions with global health authorities per internal SOPs and policies.
  • Work in collaboration with regulatory colleagues to ensure compliance and deliver efficiencies in the regulatory submission process.
  • Responsible for making independent updates in PDM Market Views for all the allotted notifications
  • Applies technical knowledge and key concepts in PDM Conformance updates. Considered as a technical resource within the work team.
  • Demonstrates good technical/functional knowledge w.r.t Regulatory requirements and internal process

Manages own work independently and guides direct reports on day-to-day activities

  • Solves moderately complex problems within area of expertise
  • Has good understanding on CMC-LCM related regulations to collaborate with the GRA colleagues in addressing the complex updates
  • Ensures the performance metrics of self and the direct report is maintained always
  • Reiews the performance of the direct reports on periodic basis updates the Manager about the Goal progress/gaps etc.
  • Shares constructive feedback to direct reports as necessary
  • Ensure timely completion of QC checks of the updates performed by collegues within the team and shares timely feedback in systematic way for the improvement areas
  • Supports with periodic reports to estimate metrics
  • Operate to the highest conformance and quality standards
  • Adhere to standard turnaround timelines for self and the direct reports
  • Always alert in providing input for continuous improvement and streamline the process
  • Supports developmental and training opportunities for direct reports and manages the performance of direct reports
  • Escalate any potential compliance issues appropriately
  • Contribute to local and regional regulatory initiatives promoting a culture aligned with Pfizer values and which supports compliance, innovation and talent development and retention.
  • Assist in ensuring internal regulatory processes and procedures are well documented
  • Assist in remediation activities as necessary
  • With good understanding on relevant regional regulations and CMC experience, acts as SME for Regions
  • Manages workload within the team for business continuity
  • Has good understanding on the tools and compliance aspects
  • Acts as a mentor for the colleagues
  • Esnures compliance on trainings and other demands for self and direct reports
  • Ensures periodic on-job referesher trainings are arranged in collaboration with respective SMEs

 

Technical Skills 

  • Knowledge and / or experience in Pharmaceutical Regulatory Affairs / Quality Assurance, especially in Life cycle management or compliance.
  • Strong quality and compliance orientation
  • Prior Regulatory experience in any of the market
  • Knowledge of regulatory practices, rules, regulations and guidelines
  • Good communication skills
  • Problem Solving
  • Understanding stakeholder needs

Standards, Processes and Policies –

  • General standards, processes and policies of Pfizer/Pharmaceutical manufacturing

Behavioral/Any other Skills –

An assertive, take-charge, results oriented, positive can do attitude, and a sense of urgency doing things done.

Preferred Qualification

– Master s / Bachelor s degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences.

Preferred Year Of Experience – 7 to 14 years

Type of Experience – Experience in a quality or compliance role within the pharmaceutical industry Demonstrated regulatory or quality experience within a pharmaceutical company with proven examples of contribution. Proven ability to consistently deliver to high quality standards and timelines. Proven ability to successfully operate in a cross functional environment

Click here to Apply 

About Company 

Pfizer Limited was listed on the Indian stock exchange in 1966. Today, the company has over one lac shareholders in India. With annual sales of over Rs. 2,000 crores, it is the fourth largest multinational pharmaceutical company in India. The Company has a portfolio of over 150 products across 15 therapeutic areas.

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