Job Description

Job title Digital Functional Expert — Regulatory Affairs

• Location Hyderabad

Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally​

Our mission: to bring health in people’s hands by making self-care as simple as it should be for over half a billion consumers worldwide.​

At the core of this mission is our 100+ loved brands, our 11,000-strong global team, our 13 best-in-class manufacturing sites and four specialized science and innovation development centers. ​

Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan.​

B Corp certified in multiple markets, we are active players in the journey towards healthier people and planet.​

Find out more about our mission to bring health in your hands at www.opella.com.​

About the role

The Digital Functional Expert — Regulatory Affairs, within the Digital Health & Science Global function at Opella, is responsible for managing and driving the end-to-end product lifecycle for Regulatory Affairs digital platforms by contributing to the end‑to‑end product lifecycle and ensuring alignment with functional, regulatory, and operational needs.

He/She ensures that the systems, projects, and processes supporting Regulatory Affairs align with business objectives, regulatory requirements, and the needs of RA teams globally.

This role acts as the critical bridge between Regulatory Affairs business stakeholders, software vendor (Veeva, Freyr), regulatory authorities, and digital/IT development teams — facilitating effective communication, decision-making, and continuous improvement across the full digital ecosystem.

Main Responsibilities

Product Backlog & Delivery Support

• Lead the definition and maintenance of the product backlog for Regulatory Affairs platforms (MLR, RIM, Labeling / Veeva, Freyr), translating business requirements into well-defined user stories, epics, and acceptance criteria.
• Write functional specifications and ensure stories are ready for development (Definition of Ready) and meet quality standards upon delivery (Definition of Done).
• Track and monitor delivery progress, flagging risks or blockers to the Product Head.
• Support issue resolution in line with Support governance, acting as a first point of contact for functional queries related to RA features.

Regulatory Affairs — Solution Enablement

• Drive the rollout and continuous improvement of Regulatory Affairs capabilities within Medical Legal Review (Veeva MLR), enabling compliant, efficient, and timely review and approval of materials by providing structured governance, standardized workflows, and traceability across medical, commercial, and regulatory stakeholders
• Participate in building the support organization for Regulatory Affairs including continuous improvement of MLR (Veeva) to support end-to-end RA operations:
• Support the configuration, validation, and lifecycle management of Veeva platforms to ensure compliant review of all materials.
• Ensure that all RA systems comply with applicable regulations: GVP modules, ICH guidelines, 21 CFR Part 11, and EMA/FDA digital submission requirements.
• Participate in UAT cycles and system validation (CSV/GxP validation) for RA systems, coordinating with Digital Quality, Security and Infra teams and RA Operations.
• Support countries and RA team members in adopting and using RA digital tools, ensuring proper training and change management.

Vendor & Support Coordination

• Act as a point of contact for day-to-day coordination with Digital Science vendors and AIMS on functional topics, ensuring support tickets SLAs are respected.
• Escalate recurring issues and contribute to continuous improvement initiatives with vendors and internal technical teams.

B — Product Governance & Stakeholder Engagement

• Handle product governance, ensuring the product roadmap is delivered on time and aligned with business expectations.
• Maintain product documentation, user guides, release notes, and training materials for regulatory affairs capabilities.
• Liaise with RA teams to gather end users feedback, usage insights, and prioritization inputs from business teams.
• Monitor product performance metrics and user adoption

QUALIFICATIONS & SKILLS

Education

• Bachelor's or master’s in business, Information Systems, Science or equivalent.

Experience

• 3–5 years as a Junior Product Owner, Business Analyst, or in a digital product/project role. Agile and AI exposure is a plus.

Regulatory Affairs

• Good Knowledge and Experience with Medical Legal Review, RIM, Electronic Product Labelling (ePIL), Regulatory Intelligence, Health Authority Interaction (HAQA).
• Use of GenAI, MLR, IDMP, SPL, SPM, IDMP, SPOR, xEVMPD, MDM etc.

Compliance

• Possesses comprehensive knowledge of Quality Assurance and regulatory compliance, including 21 CFR Part 11 and FDA regulations, ensuring technology solutions meet industry standards.

Agile & Data

• Familiarity with Scrum/Agile, Jira, and Confluence; comfort with KPI tracking and reporting tools.

Why us?

At Opella, you will enjoy doing challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day.

We Are Challengers.

We are dedicated to making self-care as simple as it should be. That starts with our culture. We are challengers by nature, and this is how we do things:

All In Together: We keep each other honest and have each other's backs.

Courageous: We break boundaries and take thoughtful risks with creativity.

Outcome-Obsessed: We are personally accountable, driving sustainable impact and results with integrity.

Radically Simple: We strive to make things simple for us and simple for consumers, as it should be.

Join us on our mission. Health. In your hands.

www.opella.com/en/careers