Pfizer Associate Job Vacancy for Life Sciences – Apply Online
Associate I – Regulatory Conformance
Locations: India – Chennai
Time Type: Full time
Posted On: Posted Today
Job Requisition ID: 4916195
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 be part of a team that will guide Pfizer by interpreting federal, state, and international regulations as they apply to products, processes, practices, and procedures. You will find yourself investigating and resolving compliance problems from within Pfizer and outside. You will keep the employees aware and knowledgeable about compliance policies by designing various programs. You will be relied on to conduct audits, compliance reviews, and evaluate current policies, procedures, and documentation.
As an associate, your focus on the job will contribute to achieving your team’s tasks and goals. This is a multifaceted role that will offer you a number of opportunities to enhance
your skills. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.
Job Summary
- Committed to quality in compliance and conformance
- Accountable for maintaining the HA status in corporate change and dossier management system for the allocated Regions / Markets
- Manages the day-to-day work by self with periodic supervision by the Lead/Designee
Job Responsibilities
- Committed to quality and excellence in compliance and conformance
With a reasonable understanding of regional regulations, would perform the evaluation of the notifications assigned. - Accountable for maintaining the HA status in corporate change and dossier management system for the allocated Regions / Markets
- Contributes independently and manages own time to meet the timelines.
- Work in collaboration with GRA colleagues to ensure the gaps are identified and escalated on time.
- Independently perform accurate updates in the system for most of the cases and consult with TL/Designee for clarification of any discrepancies in complex cases, before updating the system.
- Makes informed decisions on straight cases within guidelines and policies
- Support for updates in the system for License withdrawals
- Operate in line with internal SOPs and policies
- Adhere to standard turnaround timelines
- Escalate any potential compliance issues to management
- Support periodic and ad-hoc system reports to estimate metrics
- Contribute to local and regional regulatory initiatives promoting a culture aligned with Pfizer values
- Assist in ensuring internal regulatory processes and procedures are well documented
- Assist in remediation activities
- Support the teams in ADHOC activities
- Shares the learning time to time with the team colleagues
QUALIFICATIONS / SKILLS
Technical Skills –
- Theoretical Knowledge on Regulatory Affairs / Compliance
- Experienced in Regulatory / Quality Assurance/ Production or any other functions in Pharmaceutical or related industries
- Diligence and attention to detail
- Good communication skills
- Understanding stakeholder needs
Standards, Processes and Policies – General standards, processes, and policies of Pfizer
Behavioural/Any other Skills – An assertive, results-oriented, positive “can do” attitude, and Time management skills.
Preferred Qualification – Master’s / Bachelor’s degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences.
Preferred Year Of Experience – 2 to 4 years of experience
Type of Experience –
Any relevant experience in Pharmaceutical or relevant industry. Experience in Regulatory or Quality or Compliance roles is preferable.
Work Location Assignment: Flexible
Apply for this position here
Keywords: Pfizer, Regulatory Conformance, Compliance, Pharmaceutical Industry, Chennai, India. Pfizer Associate Job Vacancy for Life Sciences – Apply Online. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebook
I am Gopinath Santosh Wagh
I have complet my M.sc biotechnology in Government Institute of Science chhatrapti sambhajinagar