Head - Global Regulatory Affairs, ACG Capsules

ACG World; Mumbai; On-site; INR 1,000,000 - 1,500,000; Full time

Benefits offered by this job

Opportunity for global exposure

Continuous learning and development opportunities

Job summary

A leading pharma manufacturing solutions company in Mumbai is looking for a professional to strengthen its regulatory standing in pharmaceutical applications. The role involves ensuring global compliance, engaging with regulatory bodies, and optimizing regulatory strategies. Ideal candidates should have a strong education in pharmacy, experience in regulatory affairs, and the ability to collaborate with diverse stakeholders. This position offers an opportunity to lead initiatives across multiple countries and drive compliance in a dynamic environment.

Qualifications

• Proven experience in regulatory affairs, preferably in pharmaceuticals.
• Ability to manage multiple stakeholders effectively.
• Strong knowledge of cultural and organic certifications.

Responsibilities

• Lead global regulatory positioning and compliance efforts.
• Engage with regulatory bodies to ensure timely approvals.
• Develop and share regulatory newsletters and updates.
• Collaborate with internal teams for aligned regulatory outcomes.

Skills

Regulatory compliance

Stakeholder management

Cost optimization

Cultural certifications

Education

Degree in Pharmacy or related field

Tools

Digital regulatory platforms

Job description

ACG is the world’s only integrated pharma manufacturing solutions company. We are headquartered in Mumbai. The role is responsible for positioning ACG Capsules as a regulatory lighthouse across the markets and product segments it operates in & strengthening the organization’s regulatory standing in Pharmaceutical & nutraceutical applications. The role ensures global compliance, enables seamless market access, and safeguards business continuity amid evolving regulatory landscapes.

Job Objective

The incumbent will work closely with customers, internal stakeholders, and regulatory bodies to align product strategies with global regulatory requirements, while also driving cost optimization and supporting strategic business initiatives. India. ACG has a presence in over 100 countries with its products and services that strive to provide world-class technology across multiple domains. We offer a complete range of solutions beginning with empty capsules; granulation and tablet coating; capsule filling; tabletting; packaging films; blister packing and carton packing to the end-of-line solutions and track and trace systems.

Primary Responsibilities

Strategic & Functional Excellence

• Execute ACG Capsules’ functional and strategic initiatives in alignment with:
• Balanced Scorecard (BSC) objectives
• Business growth, regulatory robustness, and operational excellence
• Build and strengthen regulatory capabilities, talent readiness, and process maturity within the function.
• Contribute to positioning ACG Capsules as a trusted regulatory reference point across the markets and product segments in which it operates.
• Engage proactively with regulatory bodies to gain early visibility into upcoming regulatory developments, enabling timely preparedness and informed decision-making.

Regulatory Strategy & Compliance

• Lead the global regulatory positioning of ingredients used in Pharmaceutical & nutraceutical applications.
• Engage with regulatory authorities to support and promote the safe and compliant use of ingredients relevant to ACG’s portfolio, through constructive dialogue and collaboration.
• Oversee manufacturing licenses and regulatory documentation required for domestic and international shipments.
• Ensure end-to-end regulatory compliance for existing and new products, minimizing potential business impact arising from regulatory changes.
• Monitor, interpret, and proactively respond to evolving regulatory trends and requirements across key geographies.
• Drive regulatory filings, approvals, and registrations for manufacturing facilities across multiple countries.
• Engage with pharmaceutical and nutraceutical customers to understand emerging trends, regulatory queries, and expectations related to excipients and capsule technologies.
• Act as a regulatory subject-matter expert during customer discussions, audits, and technical clarifications.
• Support and guide customers on capsule-related regulatory aspects, including filings and regulator queries.
• Translate customer feedback and regulatory insights into actionable internal improvements.
• Develop and disseminate regulatory newsletters to share relevant updates and insights.
• Organize and participate in regulatory seminars and webinars to build awareness and thought leadership.

Regulatory Systems & Digital Enablement

• Lead the implementation of digital regulatory platforms for internal & customer documentation in CTD format, aligned with country-specific requirements.
• Standardize regulatory documentation practices to ensure data integrity, traceability, and audit readiness.
• Drive the digitalization of regulatory affairs processes, including FAQs, standard dossiers, and filing templates.
• Identify and implement cost optimization opportunities within the regulatory function while maintaining compliance integrity.
• Support ACG’s broader cost initiatives by providing practical and compliant regulatory solutions.
• Improve productivity and efficiency by streamlining regulatory workflows and optimizing resource utilization.

Certifications & Special Compliance

• Ensure compliance and flexibility across product categories, with particular focus on:
• Cultural and religious certifications (Kosher, Halal, Non GMO etc.)
• Organic certification
• Coordinate with certification bodies, auditors, and internal teams to maintain, renew, and expand certification coverage.

Stakeholder Management

• Collaborate closely with Quality, R&D, Manufacturing, Sales, Supply Chain, Legal, and other internal stakeholders to ensure aligned regulatory outcomes.
• Liaise with regulatory authorities, certification agencies, customers, and external consultants across regions to support compliance, market access, and strategic initiatives.

Any other additional responsibility could be assigned to the role holder from time to time as a standalone project or regular work. The same would be suitably represented in the primary responsibilities and agreed between the incumbent, reporting officer and HR.

Key Result Areas

• Zero or minimal business disruption due to regulatory changes
• Timely regulatory approvals and registrations across markets
• Strengthened customer confidence through proactive regulatory engagement
• Sustained certifications (Kosher, Halal, Organic) across relevant products and facilities

Measurable cost efficiencies within the function