Regulatory Affairs Specialist

Callisto Regulatory Consulting Ltd.; India; Hybrid; INR 1,500,000 - 3,000,000; Full time

Job summary

ProductLife Group is seeking a Regulatory Affairs Manager / Senior Regulatory Affairs Consultant to support medicinal products in UK and EU markets. You will develop regulatory strategies, manage submissions, and ensure compliance while guiding clients and internal teams.

You will mentor junior staff, liaise with regulatory authorities, and monitor regulatory changes to advise on product impacts. This role demands strong regulatory writing, dossier preparation, and project leadership in a global

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, or a related scientific discipline.
• Master's degree or advanced qualification is considered an advantage.

Responsibilities

• Develop and implement regulatory strategies for medicinal products across lifecycle.
• Independently prepare and manage regulatory submissions (MAAs, variations, renewals, responses).
• Coordinate regulatory dossiers per UK and EU requirements.
• Write/review regulatory and technical documents (Module 3, QOS, PIL, SmPC, labeling).
• Provide regulatory guidance to clients and internal teams.
• Serve as primary regulatory contact for clients and authorities.
• Monitor regulatory changes and advise on impacts.
• Mentor junior Regulatory Affairs staff and contribute to coaching.
• Ensure regulatory docs align with project plans and quality standards.

Skills

Regulatory strategy development

Regulatory submissions management

UK/EU regulatory knowledge

Client liaison

Mentoring junior team members

Education

Bachelor's degree in Life Sciences/Pharmacy or related

Master's degree or advanced qualification (advantage)

Job description

Make a meaningful impact on global healthcare - and grow your career while doing it. At ProductLife Group, you’ll join an innovative, forward-thinking team operating across the world to shape the future of life sciences through expertise, collaboration, and purpose-driven work.

Job Purpose

The Regulatory Affairs Manager / Senior Regulatory Affairs Consultant is responsible for providing expert regulatory support for medicinal products across the UK and EU markets. The role focuses on developing regulatory strategies, preparing and managing regulatory submissions, ensuring compliance with applicable regulations, and serving as a key point of contact for clients and regulatory authorities. The successful candidate will also mentor junior team members and contribute to the delivery of high-quality regulatory services.

Key Responsibilities

• Develop and implement regulatory strategies for medicinal products throughout their lifecycle.
• Independently prepare and manage regulatory submissions, including new marketing authorization applications, variations, renewals, and responses to regulatory authority questions.
• Compile, review, and coordinate regulatory dossiers in accordance with UK and EU regulatory requirements.
• Write and review technical regulatory documentation, including Module 3 sections, Quality Overall Summaries (QOS), packaging texts, Summary of Product Characteristics (SmPC), Patient Information Leaflets (PIL), and labeling documents.
• Provide regulatory guidance and technical expertise to clients and internal project teams.
• Serve as the primary regulatory contact for clients and liaise directly with regulatory authorities.
• Monitor and assess changes in regulations and advise clients on potential impacts to their products and activities.
• Coordinate and review technical documentation to ensure compliance with regulatory standards.
• Prepare and review user testing readability reports.
• Document, track, and maintain records of regulatory submissions and approvals.
• Support project teams by ensuring regulatory requirements are incorporated into project planning and execution.
• Review work completed by Regulatory Affairs Associates and provide mentoring, coaching, and technical guidance.
• Contribute to systems management and administrative activities related to regulatory operations.
• Deliver high-quality regulatory consultancy services while maintaining strong client relationships.

Required Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, or a related scientific discipline.
• Master's degree or advanced qualification is considered an advantage.

Required Experience

• Minimum of 5 years of experience in Regulatory Affairs within the pharmaceutical industry.
• Strong experience with UK regulatory requirements and procedures.
• Proven experience managing regulatory submissions and lifecycle maintenance activities for medicinal products.
• Experience serving as the primary regulatory contact for clients and health authorities.

Technical Skills

• In-depth knowledge of UK and EU regulatory frameworks and regulatory authorities.
• Strong expertise in regulatory dossier preparation and submission management.
• Experience writing and reviewing regulatory and technical documents.
• Sound understanding of medicinal product lifecycle management.
• Excellent analytical, organizational, and problem-solving skills.
• Strong verbal and written communication skills.
• Ability to manage multiple projects and deadlines in a fast-paced environment.

Preferred Qualifications

• Experience in medical writing.
• Previous experience mentoring or supervising junior regulatory professionals.
• Experience working in a consultancy or client-facing environment.
• Familiarity with regulatory information management systems and electronic submission platforms.

Languages

• Fluent English (written and spoken). Additional languages are considered an advantage.

Competencies

• Client-focused approach.
• Strong attention to detail.
• Excellent stakeholder management skills.
• Ability to work independently and collaboratively.
• Proactive, organized, and solution-oriented mindset.
• Commitment to quality and continuous improvement.

A path for every career stage, from graduate to senior expert
Exciting, high-impact projects with leading life sciences clients
International by design
Hybrid & flexible working
Continuous learning
An inclusive & diverse culture