Regulatory Affairs Specialist

🔥 13 hours ago

🇮🇳 India – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 12%

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ProductLife Group

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

💼 Consulting

🏥 Healthcare

💊 Pharmaceuticals

💰 GROWTH EQUITY VC on 2024-04

Consulting • Healthcare • Pharmaceuticals

ProductLife Group is a global life‑sciences consulting and outsourcing firm that pairs deep human expertise with intelligent automation to help bring therapies and health products from development to patient access. The company provides end-to-end solutions across product development (pre-clinical to approval), regulatory affairs, CMC & quality, clinical development, engineering and facility construction, market & patient access, safety and compliance, and digital & AI-enabled innovation. ProductLife Group serves biopharma, medtech and consumer health clients, operates a global network of offices covering 150+ countries, and highlights ~1,750 experts and ~10k+ submissions per year.

📋 Description

• 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

🎯 Requirements

• Bachelor's degree in Life Sciences, Pharmacy, or a related scientific discipline • 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 • 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 • Fluent English (written and spoken) • 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

🏖️ Benefits

• Opportunity to make a meaningful impact on global healthcare • Career growth opportunities • Work with an innovative, forward-thinking global team • Purpose-driven work • Remote work arrangement

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