Job Purpose To lead and manage the Regulatory Affairs function for the company's injectable business, ensuring timely product registrations, regulatory compliance, lifecycle management, and successful market authorizations across domestic and international markets. The incumbent will be responsible for developing regulatory strategies, managing global submissions, and liaising with health authorities to support business growth objectives.

Key Responsibilities

Regulatory Strategy & Leadership

- Develop and implement regulatory strategies for registration and commercialization of sterile injectable products in regulated and semi-regulated markets.
- Lead the Regulatory Affairs team and provide technical guidance on global regulatory requirements.
- Drive departmental objectives aligned with the organization's business goals and expansion plans.
- Act as the primary regulatory representative during strategic business discussions and audits.

Product Registration & Market Authorization
- Oversee preparation, review, and submission of dossiers in CTD/eCTD and country-specific formats.
- Ensure timely filing of new product registrations, variations, renewals, and responses to deficiency queries.
- Manage registrations across domestic, regulated, and ROW markets including, EU, UK, Canada, Australia, GCC, Africa, ASEAN, LATAM, and CIS regions.
- Coordinate with cross-functional teams to support product launches and market expansion activities.

Regulatory Compliance
- Ensure compliance with applicable regulatory guidelines, GMP requirements, and international standards.
- Monitor changes in global regulatory requirements and assess their impact on existing products and operations.




- Develop and implement regulatory policies, SOPs, and best practices.

Agency Interactions & Audits
- Serve as the primary contact for regulatory authorities, customers, and business partners.
- Coordinate and support regulatory inspections, GMP audits, and customer audits.
- Lead preparation and submission of responses to regulatory observations and deficiency letters.

Dossier Management & Documentation
- Ensure maintenance of accurate regulatory databases and document management systems.
- Review technical documents including product specifications, stability data, validation reports, and quality documentation.
- Oversee lifecycle management activities for approved products.

Cross-Functional Coordination
- Collaborate with R&D;, Quality Assurance, Quality Control, Manufacturing, Business Development, and Supply Chain teams.
- Provide regulatory assessments for recent product development, technology transfers, and change control activities.
- Support due diligence activities, licensing opportunities, and business partnerships.

Team Management
- Lead, mentor, and develop the Regulatory Affairs team.
- Establish performance objectives and monitor departmental productivity.
- Ensure continuous learning and development within the regulatory function.

Qualifications




- Master's Degree in Pharmacy (M.Pharm), Pharmaceutical Sciences, Life Sciences, or related discipline.
- Regulatory Affairs certification or advanced qualification will be an added advantage.

Experience
- 17–25+ years of experience in Regulatory Affairs within the pharmaceutical industry.
- Minimum 05 years of leadership experience managing regulatory teams.
- Extensive experience in sterile injectable products and global regulatory submissions.
- Proven track record of obtaining approvals in regulated and international markets.

Required Skills & Competencies
- Strong knowledge of global regulatory guidelines, ICH, WHO, GMP, FDA, EMA, MHRA, Health Canada, TGA, and other international regulations.
- Expertise in CTD/eCTD dossier preparation and lifecycle management.
- Excellent leadership, stakeholder management, and project management skills.
- Strong communication, negotiation, and regulatory intelligence capabilities.
- Ability to manage multiple projects and regulatory priorities simultaneously.
- Proficiency in regulatory documentation systems and electronic submission platforms.

Key Performance Indicators (KPIs)
- Timely regulatory submissions and approvals.
- Success rate of product registrations and renewals.
- Compliance with global regulatory requirements.
- Closure of regulatory queries within agreed timelines.
- Audit and inspection readiness.
- Team productivity and development.
- Support to new product launches and business expansion initiatives.

Preferred Industry Pharmaceutical Manufacturing – Sterile Injectables / Parenterals / Biologics / Oncology Injectables.

📌 Head of Regulatory Affairs (Panchkula)
🏢 Venus Remedies
📍 Panchkula