Regulatory Compliance Consultant

Job Title: Regulatory Compliance Consultant

Location: India (Remote)

Contract Duration: 6 - 12 month

Hours: Up to 155 hours/ month

Start Date: ASAP

Company Overview:

Apsida Life Science is partnering with a leading global clinical research organization that provides end-to-end clinical development and regulatory consulting services to pharmaceutical, biotechnology, and medical device companies. With a strong global presence, the organization supports clients across the product lifecycle, delivering expertise in clinical research, regulatory affairs, pharmacovigilance, and market access to help bring innovative therapies to patients worldwide.

Key Responsibilities:

Deviation Management

• Own and manage minor and major deviations related to Regulatory Affairs activities.
• Open and document regulatory deviations in accordance with applicable procedures.
• Lead deviation investigations from initiation through to closure.
• Coordinate investigations with all relevant Regulatory and cross-functional stakeholders impacted by the deviation.
• Assess the impact of deviations on regulatory activities, processes and deliverables.
• Ensure investigations are appropriately documented and completed within required timelines.

CAPA Management

• Define appropriate Corrective and Preventive Actions (CAPA) resulting from regulatory deviations.
• Coordinate implementation of CAPAs with relevant stakeholders.
• Establish and document appropriate CAPA effectiveness check plans.
• Monitor CAPA progress and ensure actions are completed within agreed timelines.
• Support closure of deviations and associated CAPAs.

Change Control & Compliance:

• Support Change Control management related to Regulatory Affairs activities.
• Assess the regulatory impact of proposed changes.
• Coordinate with relevant stakeholders to ensure appropriate regulatory assessment and implementation.
• Support regulatory compliance activities and ensure appropriate documentation and follow-up.
• Identify potential compliance risks and support their timely resolution.

Stakeholder Management

• Work closely with Regulatory Affairs and cross-functional teams throughout deviation and CAPA investigations.
• Coordinate activities between relevant stakeholders to ensure timely investigation, action implementation and closure.
• Communicate investigation status, actions, risks and outstanding items to relevant stakeholders.
• Support effective and compliant regulatory processes throughout the lifecycle of deviations and changes.

Requirements:

• Significant experience in Regulatory Affairs / Regulatory Operations / Regulatory Compliance within the pharmaceutical or life sciences industry.
• Proven experience managing deviations and CAPA.
• Experience acting as a Deviation and/or CAPA Owner.
• Experience opening and managing both minor and major deviations.
• Strong experience leading investigations and coordinating cross-functional stakeholders.
• Experience defining Corrective and Preventive Actions.
• Experience developing CAPA effectiveness check plans.
• Experience supporting Change Controls.
• Strong understanding of regulatory compliance processes.
• Ability to assess regulatory impact and identify potential compliance risks.
• Strong documentation, investigation and stakeholder management skills.

If you are interested in learning more, please reach out to KG Mphahlele at Apsida Life Science: [HIDDEN TEXT]

[phone removed]

Apsida Life Science is a specialist recruitment business based in London (UK), Redhill (UK), Boston (USA) Pretoria (South Africa) that is dedicated to delivering the best talent to the Life Science industry. We believe there is a gap in the market for a cost-effective, high-quality, and trusted recruitment service that puts the candidate journey at the heart of the recruitment process.