Regulatory Affairs Specialist

Job Description

Overview:

This is an opportunity to work in a key role with a broad spectrum of responsibilities in a growing healthcare company that has expanded in various domains in the industry and to contribute to the growth of the company. The vision is to build strong medical device portfolio in the regulated markets across the world, where the regulatory function plays a crucial role in this development. The Regulatory Affairs Specialist reports to the site head in India.

The work is with domestic and international focus and performed in close cooperation with several international development partners and manufacturers.

Roles & Responsibilities:

• The individual will be working on regulatory requirement of Medical devices and Distribution in various markets
• Coordinate successful submissions and approval of all medical device approval applications
• Keep up-to-date with changes in regulatory legislation and guidelines for medical devices
• Write comprehensible, user-friendly, clear product information leaflets and labels
• Review and report overall quality status to the management team
• Project management of development of new generic products
• Use a variety of specialist computer applications
• Explain regulations, policies, or procedures
• Maintain data in information systems or databases
• Evaluate applicable laws and regulations to determine impact on company activities
• Provide technical review of data or reports
• Identify and interpret relevant regulatory guidelines of drugs and medical devices
• Advice the operations and business team on applicable regulatory requirements, project specific regulatory issues as assigned.
• Act as back-up for contact with Regulatory Agencies as needed.
• Draft cover letters for Regulatory Agency communication.
• Assist in the preparation of meetings with Regulatory Agencies.
• Liaise with LOCs, and ensure responses to queries are made in a in timely manner, and that content is consistent with the regulatory strategy.
• Assist in development and improvement of processes related to regulatory submissions.
• Assist with timely availability of submission documents and ensure that all document components are in place on time.
• Draft and review some document content (depending on level of regulatory knowledge/expertise).
• Understand submission details and liaise with Submission Management.
• Review of submission documents to ensure compliance with regulatory requirements.

Desired Skills/Experience:

• Thorough understanding and demonstrated ability to apply regulatory guidelines/regulations to successful dossier preparation, submission and maintenance
• Ability to develop innovative strategies and creative solutions within the regulatory context within the scope of global requirements and available resources
• Strong initiation and organizational skills
• Outstanding written and oral communication skills, with ability to influence others and negotiate successful outcomes
• Strong analytical skill and technical/ scientific competence
• Attention to details and ability to appropriately assess risks and formulate risk-management strategies, including taking the big picture view on various options
• Team-player, able to positively influence team members at all levels with an entrepreneurial can do” attitude
• Proactive, quick learner and independent worker able to effectively multi-task in a high pressure environment and follow issues through to conclusion
• Experience from working with generics is an advantage
• Experience in pharmacovigilance is an advantage

Requirements:

• An advanced degree (MS, Pharm D, PhD) is highly preferred; a minimum of a Bachelor's Degree is required.
• 5+ year relevant experience with an advanced degree
• Understanding of the drug development process is required.
• Understanding of the regulatory submission and approval process is required.
• Knowledge of the regulatory environment, US guidelines and practices is required.
• Direct experience in regulatory affairs is required.
• Candidate must be able to work successfully within a team environment and as an individual contributor.
• Project management, oral & written communication skills, organization and multi-tasking skills are required.