7+ Regulatory affairs Jobs in India

Designation: Financial Manager 

• Exp: 8-10 Years
• CTC: up tp 30 LPA

Regulatory, Contractual & US Healthcare compliances:

• Ensure compliance to HIPAA & Hi-Tech requirements framework through audits, policy updates, external certifications, internal awareness, etc.
• Periodically update policies and document new procedures / guidelines to update the compliance plan in line with operating changes.
• Work with legal & training teams to drive the compliance programs for awareness and update of important US healthcare regulations as applicable to business.
• Work with VP, Finance, HR & Legal team across all locations to consolidate & present the compliance to regulatory requirements periodically to LT and Audit Committee.
• Update the customer contractual checklists and monitor compliance to same through periodic reviews
• Train the team on compliance programs to deliver standard compliance experience across the locations.
• Enterprise risk management (ERM), Management reviews, Investigations & Internal Audits

Cab Boundary line- 

• Navi Mumbai to Ghatkopar
• Navi Mumbai to Panvel (Ulwe not covered)
• Navi Mumbai to Kalyan

Job Purpose:

The role entails the responsibility to be a part of IT Governance and Compliance Team of the bank and would be working towards GRC control function: Compliance & Regulatory reporting viz Cyber KRI, TRANCHE, ICAAP etc.

Roles & Responsibilities:

• Custodian of IT governance and IT process governance framework.
• Handling of Regulatory audits and submissions.
• To understand Indents from regulators, collated, review the data and timely submission.
• Responsible for IT policy creation, review, update, awareness, and monitoring.
• Administration of key IT processes: E.g., incident management, policy exception management
• Will be reporting to Lead IT Governance.
• Identify improvements and breakdowns in IT governance elements with significant business impact.
• Create and maintain library of governance artifacts and other supporting documentation.
• Proactively identify and manage risks/issues, ensure proper visibility and communication occur to senior management.
• Ensures compliance with all policies and procedures in the execution of technology projects.
• Provide guidance and trainings to Project team members in the field regarding IT governance.
• Capture and share best- practice knowledge amongst the team.
• Create an environment that promotes collaborative learning and collective ownership of responsibilities.
• Strong analytical and problem-solving skills. Excellent communication and interpersonal abilities.
• Ability to work independently and collaborate effectively in a team environment.

Education Qualification (Fulltime): 

Certified Chartered Accountant (CA)

REQUIRE QUALITY ASSURANCE EXECUTIVE

EDUCATION – GRADUATE- BSC/BPHARMA

SKILLS- QA, TESTING KNOWLEDGE, REGULATORY AFFAIRS,

EXPERIENCE – MIN 3 YEARS IN PHARMA

SALARY – UPTO 35K

Job Title: QA Associate 

Job Description:

1. Responsible for Implementing, controlling and monitoring quality management system documentation (ISO 27001) and data privacy (SOC2).
2. Coordinate improvement in the system through output from audit, management review, and responsible to close NC’s during audits.
3. Knowledge of SAMD (Software as Medical Device) SaaS product, processes and procedures.

3-5 years of relevant experience in Medical Devices Industry.

Area of Expertise:

• To generate, implement and maintain internal quality procedures and systems to comply with ISO 27001, SOC2 standards
• Maintaining and updating various documents like internal docs log, external log, , Obsolete docs log, DCN, ECN, CAPA, SQA/IQA log, product complaint, equipment log
• Maintaining Engineering documents like part specs, Bill of materials, Drawings, Design review documents etc
• Co-ordinate and conduct periodic internal audits of various functional groups of an organization and drive compliance to QMS.
• Manage all documentation related to internal and external audit.
• Manage all the documents related to supplier qualification and coordinate Supplier’s audit and maintain the supplier file.
• Experience in Handling of CAPA (Corrective & Preventive Actions) & Product Complaints
• Co-ordination of Management Review Meetings & its action items implementation

Experience Required:

• 3-5 years of relevant experience in Medical Devices Industry.
• Educational Qualification – Diploma/Engineering graduate, preferably Computer Science or related.
• Ability to read and understand standard requirements independently.
• Good teamwork, communication and interpersonal skills. A demonstrated commitment to company values
• Good understanding of design control, and post marketing processes
• Knowledge of FDA / EU / Indian & other national regulations is an added advantage.
• Working knowledge of an e-QMS is an added advantage.

• Support the transition by planning and overseeing the transfer of members from one location to another, including but not limited to operational readiness, support documentation, knowledge transfer and acceptance checklists
• Support in ensuring transition activity is planned and executed to schedule, budget and scope
• Support in establishing transition end to end plans including infrastructure support models, change management, risk assessment and mitigation, resource planning and service management with clear tollgates
• Liaise with transition lead on milestone scheduling, knowledge transfer activities, and communication of progress (KPIs)
• Keep stakeholders involved in transition process and update them with the progress and roadblocks
• Promote awareness of transition planning and support processes within the GCC
• Support the Transition Lead to source and assess opportunities to expand the centre (including assessment of Make vs. Buy, offshore / on shore)
• Work directly with third party resources on a day-to-day basis to support the transition process during the set-up of the GCC

Skills:

• Proven knowledge of service transition methodology, tools and templates through experience or qualifications
• The ability to identify, escalate and manage project risks with the Transition Lead
• 3+ years of experience transitioning / offshoring / outsourcing projects / functions across sub processes such as Biostatistics, reg. affairs, clinical ops, drug safety, medical Governance, strategy and planning, pharma covigilance
• Good exposure in previous roles to multi-cultural, transversal functions
• Pharma background with experience across the systems development life cycle with experience in different project phases
• Excellent written and verbal communication skills – must be able to communicate fluently in English both verbally and in writing