Regulatory Affairs Officer

2 days ago

Vadodara, Gujarat, India Sri Sai Overseas Recruitment Full time ₹ 9,00,000 - ₹ 12,00,000 per year

Company Overview

Sri Sai Overseas Recruitment is a prominent Manpower Recruitment & Consultancy Service provider established in 2019. With a focus on recruitment for India, the Middle East, Europe, and beyond, it brings extensive experience from the Oil & Gas sectors in Gulf countries like Kuwait, Qatar, and Oman. The company operates with a deep understanding of Middle Eastern working environments and regulations, ensuring optimal recruitment services from its headquarters in Vadodara. Discover more at Sri Sai Overseas Recruitment.

Job Overview

We are seeking a Mid-Level Regulatory Affairs Officer to join our team in Vadodara on a full-time basis. The ideal candidate will bring 4 to 6 years of experience in regulatory compliance, specifically related to quality management systems and regulatory submissions. This role is crucial for navigating FDA regulations and managing product lifecycles effectively within the rapidly growing framework of our company.

Qualifications and Skills

  • Strong understanding of regulatory compliance within international markets for diverse industries.
  • Proficiency in navigating and applying FDA regulations to ensure business activities align with compliance standards.
  • Experience with implementing and managing quality management systems in alignment with industry standards.
  • Capability to prepare and manage regulatory submissions ensuring timely and accurate documentation.
  • In-depth knowledge of product lifecycle management from initial development through end-of-life processes.
  • Required experience with devising dossiers and supporting documentation for regulatory approvals.
  • Familiarity with ROW regulations and requirements to maintain global compliance across various regions.
  • Excellent communication skills to articulate regulatory requirements clearly to internal and external stakeholders.
  • Proficiency in handling technical documents to facilitate accurate and timely submissions.
  • Proven ability to review regulatory documents and submissions effectively, ensuring their accuracy and compliance.
  • Strong analytical skills to assess regulatory data and provide critical insights for decision-making.
  • Attention to detail to meticulously handle documentation and regulatory records.

Roles and Responsibilities

  • Develop and implement strategies for regulatory submissions that meet specific regional requirements.
  • Ensure all regulatory procedures and documentation are prepared, reviewed, and submitted accurately and on time.
  • Stay updated on changes in regulations and standards, and manage their impact on the company's practices.
  • Coordinate with cross-functional teams to facilitate compliance with local and international standards.
  • Conduct audits and reviews of regulatory procedures to enhance quality and compliance processes.
  • Liaise with regulatory authorities and industry experts to maintain compliance and seek guidance as needed.
  • Provide training and support to ensure staff are aware of regulatory requirements and company protocols.
  • Manage regulatory documentation and maintain an organized system for instant retrieval and review.
  • Preparation of registration dossiers as per regulatory guidelines.
  • Preparation of renewal application as per renewal guidelines.
  • Facilitate query response raised by regulatory authority and customers.
  • Preparation and submission of Safety, Quality & administrative variations as per variation guidelines.

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