Senior Product Manager

About the role

What you'll do

• Work with cross functional teams across the client organization spread worldwide spanning regulatory, business, partners, engineering, clinical trials, labelling, etc. to drive program objectives end to end from inception to delivery
• Monitor evolving global regulations and guidance from health authorities (US FDA, EMA, CDSCO and others) and convert them into product requirements and roadmap priorities.
• Influence stakeholders across the organization through effective communication, excellence in subject matter expertise and systems knowledge to plan, design and deliver programs and systems objectives that create greater impact for clients
• Act as the primary product contact for global pharma clients (US, EU and other regions), leading requirement workshops, product demos and roadmap reviews.
• Communicate product status, release plans, risks and decisions clearly to internal leadership and client stakeholders.
• Collaborate with client-side regulatory affairs, quality, supply chain and IT teams, as well as technology partners and vendors where applicable.
• Ensure data privacy and security requirements (e.g., GDPR, HIPAA where applicable) are built into product design, in collaboration with IT and security teams.
• Product Strategy & Roadmap
• Own the product vision, roadmap and prioritized backlog for pharma regulatory compliance solutions across digital labeling, serialization, traceability and supply chain.
• Conduct market, competitor and customer research to define product features, differentiation and release plans.
• Define product success metrics (client adoption, regulatory coverage, release quality, time-to-compliance) and track outcomes after release.
• Regulatory Compliance & GxP

What you'll bring

• 7+ years of experience in software product management or product ownership, including at least 3 years in the pharma or life sciences industry
• Hands-on experience building or managing regulatory compliance systems in one or more of the following areas: digital labeling / ePI, labeling and artwork management, regulatory information management, serialization, track-and-trace, or pharma supply chain.
• Working knowledge of GS1 standards and at least one major traceability regulation, such as US DSCSA, EU Falsified Medicines Directive (FMD), or India's DGFT / CDSCO track-and-trace and QR code requirements.
• Experience delivering GxP-compliant applications, with working knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5 and computer system validation (CSV / CSA).
• Proven experience working directly with global clients (preferably US / EU) in client-facing product or delivery roles.
• Excellent English communication skills across listening, reading, writing and speaking, with the confidence to present to senior client stakeholders from different cultural and language backgrounds
• Strong stakeholder management skills, with the ability to manage multiple workstreams (engineering, QA, validation, business) simultaneously.
• Strong experience with Agile / Scrum and tools such as JIRA, Azure DevOps and Confluence; ability to write clear PRDs, user stories and acceptance criteria.
• Knowledge of structured content and regulatory data standards such as HL7 FHIR (ePI), ISO IDMP, FDA SPL and EMA SPOR / PMS.
• Exposure to labeling workflows and documents (CCDS, USPI, EU SmPC / PIL) or Regulatory Information Management (RIM) platforms such as Veeva Vault.
• Experience with serialization and traceability platforms (e.g., TraceLink, SAP ATTP, rfxcel, Antares Vision, Optel) and EPCIS-based data exchange.
• Familiarity with ICH Q9 (Quality Risk Management) and ICH Q10, or with ISO 13485 and UDI requirements for medical devices and combination products.