Biocon Biologics

At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient-centricity, and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have a long-term commitment to bringing high-quality affordable biosimilars to patients all over the globe. We have proven end-to-end expertise from clone development, manufacturing, clinical development, and regulatory approvals to commercialization. About Us: Biocon Biologics is a global biosimilars company committed to expanding patient access to high quality, affordable biologic medicines. Across North America, we are building a strong commercial and market access infrastructure to support a growing portfolio of biosimilars across multiple therapeutic areas. The role offers flexibility in leveling (Manager to Director), aligned with the candidate's experience, leadership capability, and organizational fit. Final compensation will be determined based on the selected candidate's experience level and overall fit for the role. Position Summary The Manager, Government Pricing & Compliance is responsible for ensuring Biocon's compliance with U.S. government pricing and contracting requirements. This role manages day-to-day government pricing operations, reviews and approves statutory price calculations prepared by 3rd part vendor, supports government reporting and attestations, and oversees VA/FSS contracting obligations. In addition, the position supports federally required subcontracting and supplier diversity compliance activities and partners with internal stakeholders to meet applicable requirements. The role serves as a key subject matter expert and execution lead, operating within established governance and escalation frameworks. Key Responsibilities Government Pricing & Reporting Review, validate, and approve IntegriChain-prepared calculations for AMP, Best Price, ASP, Non-FAMP, FCP, URA, PHS/340B, and other statutory prices. Prepare, submit, and support attestations of government pricing reports in CMS, HRSA, VA, and DoD portals in accordance with internal approval processes. Maintain audit-ready documentation, methodologies, and supporting workpapers in compliance with SOX and internal controls. Coordinate monthly, quarterly, and annual pricing submissions and resolve data or calculation issues with internal teams and IntegriChain. Strategic Pricing Support Provide pricing and compliance guidance to Commercial, Finance, and Contracting teams related to: Best Price implications of contracting strategies. PHS/340B pricing mechanics and downstream impacts. Baseline AMP establishment and long-term pricing considerations. Appropriate use of alternative AMP and 5i methodologies. Support scenario modeling and impact assessments for new product launches, pricing changes, and contracting strategies. Review 340B claim scrubbing processes for medical and pharmacy benefit invoices and support 340B rebate reform initiatives as applicable. Engage in cross-functional initiatives related to FMV analysis, bona fide service fees, state transparency reporting, and other pricing-related special projects Government Contracting & Federal Compliance Manage and coordinate required submissions and documentation for: Public Law 102-585 reporting. VA Federal Supply Schedule (FSS) contracting. Commercial Sales Practices (CSP) disclosures. Requests for Modification (RFM) related to new launches or product changes. Support ongoing compliance with VA, DoD, OGA, and other federal agency requirements. Maintain annual SAM.gov registrations and related federal certifications. Track contract obligations, deadlines, and compliance requirements in collaboration with Legal and Contracting teams. Keeping track of new regulatory development in govt pricing and monthly reporting to NorAm leadership for changes Small Business Subcontracting & Supplier Diversity Develop, implement, and maintain Biocon's Small Business Subcontracting Plan in compliance with FAR 52.219-9. Prepare and submit subcontracting reports through eSRS, including Individual Subcontract Reports (ISR) and Summary Subcontract Reports (SSR). Partner with Procurement to: Identify and engage diverse suppliers (small, minority-owned, women-owned, veteran-owned, HUBZone, etc.). Support achievement of federal small business participation goals. Monitor and report progress against subcontracting targets. Provide guidance and training to internal stakeholders on subcontracting and supplier diversity requirements and best practices. Audit, Risk & Governance Support internal and external audits related to government pricing, contracting, and subcontracting compliance. Coordinate responses to inquiries from CMS, VA, HRSA, SBA, and other agencies, escalating issues as appropriate. Maintain SOPs, pricing methodologies, and compliance documentation. Ensure compliant handling and documentation of fee structures, including reviews of bona fide service arrangements and fair market value assessments, in partnership with Legal and Finance. Government Systems & Portals Manage, maintain, and submit required filings through government systems, including: CMS portals (monthly and quarterly AMP and ASP submissions) HRSA portal (quarterly PHS/340B pricing) VA portals (including Industrial Funding Fee IFF ) eSRS (annual and periodic subcontracting reports) SAM.gov (annual renewals and updates) Qualifications & Education Bachelor's degree in finance, Economics, Business, or a related field. 7+ years of experience in pharmaceutical government pricing, reporting, and compliance. Hands-on experience with IntegriChain government pricing solutions. Experience supporting VA/FSS contracting, CSP disclosures, Public Law compliance, and SBA subcontracting plans. Skills Strong analytical and problem-solving skills with attention to detail. Ability to interpret complex regulations and apply them in operational settings. Advanced Excel skills, including pricing analysis, reconciliations, and audit support. Strong communication and stakeholder management skills. Preferred Attributes Self-motivated government pricing and compliance subject matter expert. Collaborative team player with the ability to work cross-functionally. Proactive, detail-oriented, and solutions-focused with a strong ownership mindset. Positive, professional attitude with the ability to manage competing priorities. Biocon Biologics is an Equal Opportunity, EEO / Affirmative Action Employer committed to excellence through diversity. All qualified applicants will receive consideration for employment without regard to, and no employee shall be discriminated against because of their race, color, religion, age, sex (including pregnancy), national origin, disability, genetic information, status as a protected veteran or any other characteristic protected by applicable federal, state or local law.