Regulatory Affairs Associate

About the Company : Company is dedicated to supporting healthcare professionals and patients worldwide. Our mission is to improve patient outcomes through innovative products and services, while fostering a culture of compliance and integrity.

About the Role : The Compliance Associate is a key member of the local Compliance function, responsible for supporting the effective implementation and continuous improvement of companies Compliance Management System (CMS) in India (including export markets in South Asia), reporting to the LCO.

Responsibilities :

• Investigations Support (core responsibility) :
• Open and log cases and whistleblower reports on the Case Management System (NAVEX).
• Conduct investigations by performing document review, samples check, data analysis, e-Discovery and subject interviews.
• Travel to office locations and / or other vendors to conduct a site visit to gather evidence.
• Keep a good record of investigative steps and ensure a timely update on the Case Management System.
• Support the LCO on handling compliance cases in accordance with FK’s Case Management SOP, under the supervision and guidance of the LCO and RCO.
• Conduct pre-assessment by analysing complaints and whistleblower reports and identify key compliance issues and evidential leads for further investigative steps.
• Liaising with key informants such as whistleblowers, and / or other business and functional teams which have information relating to the pre-assessment and the investigations.
• Prepare for investigations by drafting interview questionnaires, gathering and organizing evidential materials, and structuring a ‘game plan’ and briefing the LCO and RCO on investigative strategies before proceeding to interviews.
• Lead and / or support investigative interviews by questioning subjects of investigation and taking minutes for the interview.
• Write up pre-assessment conclusion (in case the matter does not lead to formal investigations) and investigation reports (in case the matter results in an investigation).
• Suggest and follow up on remedial actions (e.G. disciplinary actions, process improvements, training) following from the findings identified in investigations.
• Monitoring Activities and Spot Checks :
• Under the supervision and guidance of the LCO, conduct monitoring activities and spot checks on business / promotional activities and interactions with Healthcare Professionals (HCP) and Healthcare Organisation (HCO).
• Plan and design a plan for monitoring activities, detailing dates, time, frequency, sampling criteria, and mode of monitoring for Product Promotion Activities (PPA) and Continuous Medical Education events (CME).
• Conduct regular event spot checks, both on-site and remote, as planned, on PPA and CME, and record the monitoring observations (and create a template with the LCO for such report).
• Conduct post-event / reimbursement sample checks to verify whether documentation is provided sufficiently and according to defined standards, and record the monitoring observations (and create a template with the LCO for such report).
• Monitor the event spend against pre-defined soft caps (monetary thresholds), alert the LCO and business in case certain activities are about to exceed the soft caps.
• Apply knowledge from investigations to update and enhance the monitoring activities to ensure they stay relevant and address the key risks as identified.
• Suggest continuous improvement and explore ideas of technology and IT applications to improve the efficiency and effectiveness of monitoring activities.
• Business Partner Due Diligence (BPDD) :
• Conduct Business Partner Due Diligence, as supervised and delegated by the LCO.
• Ensure all required documentation is compiled in BPDD request.
• Review and check information provided in BPDD Questionnaires.
• Conduct a search on BP on the Compliance Catalyst tool and document results.
• Conduct public media search on BP (e.G. Google, or other searching engines / platforms as applicable in India).
• Generate awareness and train employees on the BPDD process.
• Monitor BPDD validity and liaise with business or functional teams to ensure BPDD remain all up to date.
• Support LCO on other CMS tasks as assigned :
• Under the supervision and guidance of the LCO, provide daily advisory to business and functional colleagues.
• Assist the LCO in preparing for and supporting various audits, external or internal.
• Take on other tasks as assigned by the LCO or RCO from time to time.
• Generate awareness and help foster a compliance and speak-up culture, e.G. in local Compliance Ambassador programme.
• Assist the LCO in generating compliance content such as training materials, compliance reports to local management, Regional and Global Compliance, and risk assessment etc.
• Monitor local legal environment and conduct research on local laws and regulations, industry codes, e.G. UCPMP Code, Drugs and Cosmetics Act, and Data Privacy guidelines etc.

Qualifications :

Required Skills :