Regulatory Executive Support

5 days ago

Pimple Soudagar Pune Maharashtra, India CP HR Services Pvt Full time ₹ 3,60,000 - ₹ 4,20,000 per year

Job Title: Regulatory Affairs Executive

Experience: 2+ years

Qualification: Bachelor's degree in pharmacy, Life Sciences, or related discipline.

Location: Pimple Soudagar, Pune

About the Company:

We are a UK's leading healthcare company specializing in pharmacy services, wholesale pharmaceutical supplies, and a next-generation healthcare app that connects patients, clinics, and prescribers. We are committed to improving access to healthcare through innovation, technology, and service excellence

Job Summary:

We are seeking a detail-oriented Regulatory Affairs Executive to ensure compliance with UK MHRA guidelines and global regulatory standards. The role involves managing documentation, logistics, and stakeholder communication while coordinating with internal and external partners to support regulatory operations.

Key Responsibilities:

  • Regulatory Compliance:
  • Apply UK MHRA GDP guidelines to pharmaceutical wholesale operations in the UK, EU, and beyond.
  • Stay updated on global regulatory standards and ensure adherence.
  • Documentation Management:
  • Prepare, review, and maintain regulatory documents such as SOPs, risk assessments, and CAPAs.

  • Validate customer and supplier profiles as per SOPs and manage ERP system updates

  • Stakeholder Coordination:

  • Collaborate with internal departments for technical and quality documentation.

  • Communicate with regulatory authorities, customers, and suppliers for account openings, registrations, and compliance matters.

  • Logistics & Export Documentation:

  • Coordinate shipments from the UK warehouse, manage export documentation, and track deliveries.

  • Follow up with customers on shipment receipts and temperature logger data.

  • Customer and logistics company invoices tally and track of it

  • Annual Regulatory Activities:

  • Plan and oversee activities like customer/supplier revalidation, SOP updates, and recalls.

  • Monthly updates on each month's shipments documents and warehouse update.

  • Sample Management:

  • Organize and dispatch samples for registration with health authorities.

Skills & Competencies:

  • Regulatory Knowledge: Understanding of UK MHRA GDP and pharmaceutical terminology.

  • Technical Skills: Proficiency in MS Office, ERP systems, and strong analytical abilities.

  • Communication: Excellent written and verbal skills for stakeholder engagement.

  • Attention to Detail: High accuracy and thorough documentation.

  • Personal Attributes: Confident decision-making, proactive, and ability to perform under pressure.

Preferred Qualifications:

  • Bachelor's degree in pharmacy, Life Sciences, or related discipline.

  • Experience in regulatory affairs, pharmaceutical distribution, or logistics coordination.

Job Type: Full-time

Pay: ₹20, ₹35,000.00 per month

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