Senior Executive, Regulatory Operations & Compliance

Advanz Pharma Corp; Mumbai; On-site; INR 1,200,000 - 1,800,000; Full time

Benefits offered by this job

Global recognition programme

Long Service Award

Employee Assistance programme

Birthday leave

Volunteering leave

Agile working

Work from Anywhere

Job summary

ADVANZ PHARMA in Mumbai (Andheri) seeks a Senior Executive, Regulatory Operations & Compliance to join the Regulatory Publishing team. You will execute XEVMPD/IDMP submissions, maintain regulatory data, and support system improvements while ensuring compliance with European and regional requirements.

The role requires 5+ years in regulatory submissions, knowledge of IDMP/ISO guidelines, and strong collaboration across functions.

Qualifications

• Degree or Post-graduation qualification in Pharmacy.
• Experience with XEVMPD submissions to EMA via gateway and related regulatory systems.
• Knowledge of electronic Document Management Systems (e.g. Veeva Vault RIM) and XEVMPD/IDMP tools.

Responsibilities

• Execute and coordinate XEVMPD/IDMP submissions to EMA and maintain timelines.
• Provide regulatory data management support across RIMS, EDMS, and SPOR/IDMP platforms.
• Support implementation, validation, and continuous improvement of regulatory systems and processes.

Skills

XEVMPD submissions

Regulatory data management

Regulatory systems implementation

Excellent communication

Change adaptation

Education

Pharmacy degree

Tools

Veeva Vault RIM

XEVMPD/IDMP tools

Job description

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Senior Executive, Regulatory Operations & Compliance

Job Title:Senior Executive, Regulatory Operations and Compliance

Location:Andheri, Mumbai (Hybrid working)

About the Role

As ADVANZ PHARMA continues to strengthen its position as the partner of choice for specialty, hospital, and rare disease medicines, we are seeking aSenior Executive, Regulatory Operations & Compliance to join ourRegulatory Publishing team.

The primary purpose of this role is to support ADVANZ PHARMA’s Regulatory function through the execution and coordination of XEVMPD/IDMP submissions, ensuring all submissions meet applicable internal quality standards and external regulatory requirements. The role will contribute to XEVMPD/IDMP implementation activities and support the development of processes that enhance regulatory data management and compliance.

The position is responsible for supporting the maintenance of XEVMPD (eXtended EudraVigilance Medicinal Product Dictionary) and IDMP data, with a strong focus on ensuring ongoing compliance with European Article 57 requirements and related regulatory obligations.

The role will also support the implementation, maintenance, and continuous improvement of Regulatory systems and processes, working collaboratively with cross-functional stakeholders to help ADVANZ PHARMA meet its regional and global regulatory commitments

What You'll Be Responsible For

• Execute and coordinate XEVMPD/IDMP submissions, ensuring electronic submissions meet internal quality standards and external regulatory requirements within agreed timelines.
• Provide operational support and subject matter knowledge related to ISO IDMP standards, EU Implementation Guide, SPOR, ePI, PLM, PMS and IRIS requirements.
• Support the execution of IDMP operational activities and contribute to ongoing IDMP implementation initiatives.
• Contribute to the development, implementation and continuous improvement of regulatory processes, procedures and system-related workflows.
• Collaborate with cross-functional stakeholders to support the implementation, maintenance and compliance of Regulatory Information Management Systems (RIMS), Electronic Document Management Systems (EDMS), Publishing Systems and XEVMPD/IDMP platforms.
• Monitor developments in electronic regulatory requirements and maintain awareness of evolving regulations, standards and industry best practices.
• Create, maintain, quality check and support compliance activities related to XEVMPD/IDMP submissions and associated regulatory data.
• Track submission status and provide timely updates to relevant stakeholders within the Regulatory function.
• Perform IDMP-related data migration, mapping, cleansing, validation and enrichment activities to support regulatory compliance.
• Support regulatory systems projects through participation in system testing, validation and implementation activities.
• Maintain and update regulatory procedures, work instructions (WIs), SOPs and system-related documentation to ensure compliance and consistency.
• Provide user support, troubleshooting assistance and training for regulatory systems and processes, acting as a Super User where applicable.
• Perform and support data management activities related to SPOR and IDMP master data maintenance.
• Deliver training and end-user communications on IDMP-related processes, data management requirements and regulatory system updates.
• Support the identification, documentation and resolution of regulatory compliance issues and data-quality risks.
• Assist Product and Company M&A integration activities by supporting regulatory data migration and harmonization efforts.
• Coordinate regulatory portal and gateway access administration, including user support and training for platforms such as PLM, IRIS and ESG.
• Thrive in an entrepreneurial environment and take accountability for results.
• Embrace challenge and change, applying a growth mindset approach.
• Have a bias for action and fast decision-making.
• Consistent demonstration and embodiment of company core values: Entrepreneurship, Speed, and Integrity.
• Drive the spirit of “One Team” by working collaboratively across all business functions with open, honest, and respectful cooperation.
• Contribute to making ADVANZ PHARMA a desired place to work.

What We're Looking For

We're looking for ambitious, resilient, and commercially minded professionals who are passionate about improving patient outcomes and driving business growth.

For this role, you will also have the following:

Qualifications

• Degree or Post-graduation qualification in Pharmacy.

Knowledge, Skills & Experience

• Over 5 years of experience in XEVMPD submissions to EMA via gateway, its maintenance.
• Knowledge and hands on experience of electronic Document Management Systems (e.g. Veeva Vault RIM) and XEVMPD/IDMP tools
• Good understanding of ICH and regional regulatory guidelines – should be able to interpret guidelines and apply them in practical situations
• Significant experience with validation/Implementing Regulatory systems for XEVMPD/ISO IDMP.
• Excellent communication skills, both oral and written, to connect with senior management internally & in third-party suppliersor service providers.
• A positive and ‘can-do’ approach , biased towards finding solutions and embracing change
• Inspired by our values of entrepreneurship, speed and integrity.
• Learning agility and ‘scalability’, with a desire to continuously improve and develop as ADVANZ PHARMA grows.
• Work collaboratively across all business functions with an open, honest, and respectful cooperation.
• Ability to have fun and thrive in a growing, unique, and inclusive work environment.

At ADVANZ PHARMA, our purpose is clear: improving patients' lives by increasing access to medicines that matter. We are a fast-growing international pharmaceutical company where employees have the opportunity to make a tangible impact, take ownership, and contribute to meaningful work every day.

A Place Where You Can Grow

We foster a culture built on trust, collaboration, inclusion, and continuous development. Whether you're expanding your commercial expertise, taking on new challenges, or building your career within a growing organisation, you'll be supported to succeed.

Entrepreneurial by Nature

Our teams are empowered to make decisions, challenge convention, and create solutions that drive results. We value people who bring energy, accountability, and a desire to make things happen.

A Meaningful Mission

Every role at ADVANZ PHARMA contributes to improving access to important therapies for patients across the globe. The work you do will have a direct impact on healthcare professionals, healthcare systems, and ultimately the patients they serve.

Flexibility and Support for Your Wellbeing

Our agile and flexible working arrangements, paired with a comprehensive compensation and benefits package, are designed to support your health, career aspirations, and work-life balance.

We are delighted to offer a comprehensive package designed to support the health, well-being, and professional growth of our employees.

• Global recognition programme
• Long Service Award
• Employee Assistance programme
• Birthday leave
• Volunteering leave
• Agile working [ for office-based employees only ]
• Work from Anywhere subject to local legislations [ for non field based employees only ]

Our People Recommend Us

We're proud that 82% of employees in our 2026 engagement survey said they would recommend ADVANZ PHARMA as a great place to work.