Regulatory Affairs Specialist for Medical Industries

Job Description: Freelance Regulatory Affairs Specialist Position Title: Regulatory Affairs Freelancer (Medical Devices & Pharmaceuticals) Location: Remote (with occasional on-site visits as per project requirements) Project Scope: Submission and Regulatory Compliance for DCGI and CE Role Overview: We are seeking an experienced Regulatory Affairs Freelancer with 8-10 years of expertise in the submission and regulatory compliance processes for medical devices and pharmaceuticals. The ideal candidate must have an in-depth understanding of the regulatory requirements and guidelines set by the Drug Controller General of India (DCGI) and European CE marking processes. This project-based role focuses on ensuring timely and successful submissions and approvals in these regions. Key Responsibilities: 1. Regulatory Submissions: o Lead the preparation, review, and submission of comprehensive dossiers for medical devices and pharmaceuticals to DCGI. o Develop detailed CE marking submissions in accordance with European regulatory requirements (EU MDR). 2. Compliance Management: o Ensure full compliance with DCGI and EU regulatory guidelines, directives, and acceptance criteria. o Keep abreast of regulatory changes and proactively adapt submission strategies to align with updated guidelines. 3. Authority Engagement: o Act as the primary point of contact with regulatory bodies, addressing technical queries, resolving objections, and facilitating approvals. o Provide strategic advice to internal stakeholders based on regulatory feedback. 4. Documentation and Quality Assurance: o Compile, organize, and review all necessary documents to meet regulatory standards. o Implement rigorous quality checks to ensure accuracy and completeness of submissions. 5. Project Leadership: o Develop timelines and oversee the submission process to meet critical project milestones. o Offer strategic guidance to improve submission success rates and streamline compliance processes. Qualifications and Experience: • Education: o A Bachelor's or Master's degree in Pharmacy, Life Sciences, Biomedical Engineering, or a related discipline. • Experience: o 8-10 years of proven experience in regulatory affairs, specifically in:  DCGI submissions for medical devices and pharmaceuticals.  European CE marking submissions with a solid grasp of EU MDR requirements. o Demonstrated success in securing regulatory approvals from Indian and European authorities. • Knowledge Base: o Comprehensive knowledge of DCGI guidelines, CE marking processes, and EU MDR. o Familiarity with ISO standards, ICH guidelines, and global regulatory frameworks is highly desirable. • Skills: o Excellent attention to detail, organizational, and problem-solving skills. o Strong communication and interpersonal skills, especially when engaging with regulatory authorities. o Proficiency in regulatory submission software and document management systems. Preferred Attributes: • Experience in handling complex or large-scale submissions with minimal oversight. • Ability to work independently and make strategic decisions under tight deadlines. • Prior freelance or consulting experience in regulatory affairs. To Apply, Submit: 1. Updated CV emphasizing relevant regulatory experience. 2. Examples of previous approvals (if permissible).