Position: Product Policy Manager, Consumer Product Join our forward-thinking team as a Product Policy Manager, Consumer Product and play a pivotal role in our continued success. This role provides exposure to strategic initiatives and direct collaboration with senior leadership. Role Responsibilities: Represent the department in cross-functional forums, workshops, and leadership reviews. Conduct audits to ensure adherence to applicable best practices and standards. Identify process improvement opportunities and lead efficiency enhancement initiatives. Support the recruitment, onboarding, and capability development of team members. Participate in strategic planning and contribute to departmental roadmaps. Review workflows to identify gaps and recommend evidence-based solutions. Collaborate with cross-functional teams to ensure seamless delivery of projects. Ensure timely delivery of all assignments while maintaining highest quality standards. Education and Experience Requirements: Experience collaborating within cross-functional teams and matrix organisational structures. Proven ability to manage competing priorities in a deadline-driven, dynamic environment. Excellent verbal and written communication skills; fluency in English is essential. A bachelor's degree or higher in a relevant field; postgraduate qualifications are an added advantage. Minimum 35 years of progressive professional experience in a comparable role. High degree of professionalism, integrity, and alignment with organisational values. Strong working knowledge of Microsoft Office Suite and relevant digital tools. This role offers exceptional career growth, a collaborative culture, and a compensation structure aligned to market benchmarks.

Acts as primary liaison between the company and drug regulatory authorities. Coordinates pre-submission meetings with CDSCO for new drug applications. Manages relationships with state drug controllers and licensing authorities. Handles import and export licensing, NOC applications, and drug controller approvals. Monitors CDSCO website and official gazette for new regulatory notifications. Manages manufacturing and loan license amendments with state licensing authorities. Prepares responses to inspection reports and show cause notices from authorities. Coordinates GMP inspection readiness and manages inspection schedules. Manages drug registration renewal schedules and maintains approval status database. Provides regulatory guidance to management on compliance and operational decisions. Coordinates with customs authorities for import documentation and clearances. Prepares compliance status reports and regulatory risk dashboards for management. Stays current with Drugs and Cosmetics Act amendments and CDSCO orders.

Identifies and evaluates new business opportunities including licensing and partnerships. Develops business case analysis for new product acquisitions and in-licensing deals. Conducts market assessment and commercial due diligence for new opportunities. Negotiates term sheets and licensing agreements with international partners. Manages relationships with global pharma companies, biotech firms, and innovators. Screens product pipeline and identifies products aligned with therapy area strategy. Coordinates technical and regulatory due diligence with R&D and RA teams. Prepares NPV models, financial projections, and investment proposals for management. Supports contract manufacturing and contract research organization agreements. Monitors industry trends, patent expiries, and generic opportunity pipeline. Represents the company at partnering conferences including CPhI and BioPartnering. Coordinates with legal team for contract drafting and agreement finalization. Stays updated with pharma M&A trends, licensing deal structures, and valuations.

Prepares and submits drug registration applications to CDSCO and state FDAs. Compiles Common Technical Documents (CTD) for global market submissions. Manages drug master files, certificates of analysis, and GMP certificates. Handles clinical trial authorizations and IND application filings. Monitors regulatory timelines and tracks submission progress. Responds to queries from regulatory authorities on pending applications. Manages license renewals, amendments, and post-approval changes. Stays updated on CDSCO notifications, drug alerts, and regulatory revisions. Reviews and approves labelling, package inserts, and patient information leaflets. Coordinates with international regulatory affairs teams on global filings. Manages regulatory database and filing systems for all products. Supports pre-submission meetings with regulatory health authorities. Trains team members on regulatory submission standards and tools.

Position: Clinical Manager - Oncology An exceptional opportunity has arisen for a talented Clinical Manager - Oncology to contribute to our mission. The successful candidate will be part of a collaborative, high-performance environment committed to excellence. Scope of Responsibilities: Maintain up-to-date knowledge of ICH E2A-E2F, GCP, and pharmacovigilance regulations. Ensure all cases are coded and processed per MedDRA and applicable global standards. Support collection and review of adverse event safety data from clinical and post-market sources. Liaise with clinical, medical affairs, and regulatory teams for accurate safety data management. Ensure audit-readiness of safety documentation in line with GxP and regulatory expectations. Prepare high-quality clinical and regulatory documents aligned to CTD submission standards. Conduct structured literature reviews and contribute to scientific summaries and labelling. Contribute to risk management plans, SOPs, and signal detection and evaluation processes. Competencies and Qualifications: Strong interpersonal and stakeholder management skills with a client-service orientation. Detail-oriented mindset with the ability to synthesise and present complex information clearly. Proficiency in relevant software and digital tools specific to the functional area. At least 24 years of hands-on experience in a comparable professional setting. Exceptional organisational skills with the ability to handle multiple concurrent responsibilities. Bachelor's degree in a relevant discipline; master's degree or professional certification is preferred. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. We offer a competitive remuneration package commensurate with experience and market standards. Qualified candidates are encouraged to apply.