Senior Product Manager

Deevita LLC; United States; Hybrid; USD 140,000 - 190,000; Full time

Benefits offered by this job

Health insurance

Paid time off

Flexible hybrid work

Job summary

DeeVita seeks an experienced Senior Product Manager to own the vision, roadmap and delivery of regulatory compliance software for the pharmaceutical industry, covering digital labeling, serialization and track-and-trace, with global clients and cross-functional teams.

You will translate regulatory requirements (GS1, DSCSA, EU FMD, ePI, GxP) into scalable products, partnering with engineering, QA and validation, and ensuring data privacy and security across regions.

Qualifications

• 7+ years of software product management or product ownership experience, including pharma or life sciences exposure.
• Hands-on experience building or managing regulatory compliance systems (digital labeling/ePI, labeling and artwork management, regulatory information management, serialization, track-and-trace).
• Experience with GxP-compliant applications and CSV/CSA validation.
• Experience with global clients in client-facing roles, preferably US/EU.
• Strong English communication and stakeholder management skills.
• Familiarity with Agile/Scrum and tools like JIRA, Azure DevOps and Confluence.

Responsibilities

• Own the vision, roadmap and delivery of regulatory compliance software products and services.
• Translate regulatory requirements into product requirements, PRDs and roadmaps; work with engineering, QA and validation teams.
• Lead requirement workshops, demos and roadmap reviews with global pharma clients.
• Ensure data privacy and security requirements are embedded in product design (GDPR, HIPAA where applicable).
• Drive Agile delivery with cross-functional teams and manage risks across workstreams.
• Ensure quality gates, testing, UAT and validation sign-off before releases.

Skills

Regulatory compliance

Product management

Agile / Scrum

Client-facing

Stakeholder management

GxP / CSV knowledge

GS1 / DSCSA knowledge

Tools

JIRA

Azure DevOps

Confluence

Job description

Job Description:

DeeVita is seeking an experienced Senior Product Manager to own the vision, roadmap and delivery of our regulatory compliance software products and services for the pharmaceutical industry, spanning digital labelling, serialization and track-and-trace, and supply chain traceability. You will work directly with global pharma clients, translating complex regulatory requirements and industry standards such as GS1, DSCSA, EU FMD, ePI and GxP into validated, scalable products. You will partner closely with engineering, QA and validation teams, and with client stakeholders in regulatory affairs, quality and supply chain, from discovery through release.

We are a team of talented, collaborative engineers who are passionate about making a difference in the healthcare and pharmaceutical industry. Join us to help shape how medicines are labeled, tracked and safely delivered to patients worldwide, using modern technology in a fast-paced, supportive environment.

Roles & Responsibilities:

Program Management

• 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

• Translate regulatory requirements into clear PRDs, epics, user stories and acceptance criteria, with end-to-end traceability from requirement to test (Requirements Traceability Matrix).
• Ensure products are designed and released as GxP-compliant systems in line with 21 CFR Part 11, EU GMP Annex 11 and GAMP 5 (CSV / CSA), including audit trails, electronic signatures, role-based access and data integrity (ALCOA+).
• Partner with QA and validation teams on validation deliverables such as URS, FS, risk assessments, IQ/OQ/PQ and validation summary reports, and support client audits and vendor qualification.
• Embed industry standards into product design, including GS1 (GTIN, GLN, SSCC, GS1 DataMatrix, EPCIS) and structured product information standards (HL7 FHIR ePI, ISO IDMP, FDA SPL).

Delivery & Execution

• Drive Agile delivery with engineering and QA, including sprint planning, backlog refinement and release planning, aligned with formal change control for validated releases.
• Identify and manage risks, issues and dependencies across workstreams; drive timely mitigation and escalation.
• Ensure quality gates (testing, UAT, validation sign-off) are met before every release goes live.
• Drive Agile delivery with engineering and QA, including sprint planning, backlog refinement and release planning, aligned with formal change control for validated releases.
• Identify and manage risks, issues and dependencies across workstreams; drive timely mitigation and escalation.
• Ensure quality gates (testing, UAT, validation sign-off) are met before every release goes live.

Required Qualifications:

• 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.

Preferred Qualifications:

• 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.
• Experience with AI / ML‑enabled features in regulatory, labeling or supply chain workflows.
• Certifications such as CSPO, SAFe POPM, PMP or PMI‑ACP.

Benefits:

• Industry-competitive compensation package.
• Opportunity to build products at the intersection of technology and pharma regulation, used by global clients.
• Opportunity to work global pharmaceutical challenges with major clients and excellent career growth across product, domain and leadership tracks
• Paid time off (EL, SL, CL) and health insurance coverage.
• Flexible Hybrid work arrangements