At CliniLaunch, we are dedicatedly providing comprehensive and cutting-edge training and certification programs to healthcare professionals or students seeking a successful career in the pharmaceutical, biotechnology, life sciences, and medical fields. We specialize in Clinical Research, Medical Coding, Clinical SAS, Pharmacovigilance domain, and ensure that pharma graduates should be well-equipped with the knowledge and skills required for their career growth and expansion.
Course Name
Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support.
Post : Associate I – Regulatory Conformance
Job Description
As an associate, your focus on the job will contribute in 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 Description
• Committed to quality and excellence in compliance and conformance
• With the 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 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 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
Technical Skills
• Theorotical 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
Behavioral/Any other Skills – An assertive, results oriented, positive “can do” attitude, and Time management skills. Preferred
Candidate Profile
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.
Additional Information
Experience : 2 to 4 years
Qualification : Master’s / Bachelor’s degree or equivalent
Location : Chennai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory
End Date : 20th May 2024
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