Senior Associate

1 week ago

Bengaluru, Karnataka, India ClinChoice Full time

Job Title:
Senior Associate – Regulatory Affairs

Employment Type:
Full time

Location:
Bengaluru/Hyderabad, India

About ClinChoice
ClinChoice partners with many of the world's leading pharmaceutical, medical device, and consumer care innovators. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering optimal strategies for product registration, and enhancing patient safety through real-world and clinical analysis.

Our global delivery network includes centers and satellite offices in the United States, Mexico, the United Kingdom, Armenia, China, Japan, India, and the Philippines, supporting our customers in maintaining regulatory compliance both locally and globally.

We have forged future-focused partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision.

Primary Responsibilities

  • Responsible for building, publishing, and archiving activities, along with associated tasks for assigned regulatory submissions within agreed timelines.
  • Adhere to quality procedures and standards related to submission publishing.
  • Ensure the appropriate use of document management systems, publishing platforms, and validation tools through established working practices and quality-control steps to maintain regulatory compliance.
  • Support other team members with submission workload when necessary, providing flexible support for the submission portfolio.
  • Support global/local teams by completing tasks assigned by submission coordinators.
  • Adhere to Pfizer compliance standards.

Candidate Profile

  • Bachelor's or Master's degree in Pharmacy or Life Sciences.
  • Strong English language skills, both written and verbal.
  • Good interpersonal skills with excellent collaboration capabilities.
  • Proactive and initiative-driven.
  • Solution-oriented in approach.

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