Specialist, Regulatory Affairs and Quality Assurance, South Asia

What You Can Expect

The Regulatory Affairs Specialist is responsible for implementation of regulatory compliance systems and support Regulatory Affairs activities. He/she participates in all activities relating to preparation, submission and follow up to obtain approvals/renewals for products and its variations & line extension indications and labeling approvals of medical devices of various business units. He/ she will be responsible for providing technical support by interpreting federal and local regulations as they apply to products, processes, practices and procedures.

How You'll Create Impact

Key Responsibilties

• Manage, plan and execute the preparation, review and submission of dossiers for product registrations, import licenses and other approvals from regulatory agencies (registrations and renewals) thereby supporting the business units and supply chain management in compliance with regulatory requirements in the Indian Sub-Continent.
• Coordination with global regulatory teams, local BU & other functions, for regulatory strategies and all documentation support required for regulatory submissions in Indian Sub-Continent.
• To understand and help influence medical device regulatory environments by leveraging key relationships with the Authority and with industry groups.
• Proactively work with the government officials and other agencies in resolving pre and postmarket registration issues.
• To provide assessment of the new and changing regulations for any impact. Outline the plan for mitigation of impact, communicate to stakeholders and implement.
• Submit and track registration/re-registration applications with the authorities. To maintain databases of all submissions and approvals.
• To support internal systems and processes, relating to regulatory and quality, e.g. GRP, GSP, Change Notifications, SAP, GTS
• Liaise with product divisions and obtain relevant details for filing changes to the approved products/licenses.
• Assess the Change controls from the product divisions through post approval change management and continuously ensure regulatory compliance (reporting of adverse events/field actions, etc.).
• Understanding & interpretation of law & the local regulatory requirement and implementing same in submission with compliance.
• Close monitoring of any changes in local & global regulations and communicating same within the department and respecting & following all SOP / system implemented within the department and organization.
• Ensure business continuity through regulatory filings, obtaining regulatory approvals and continuously ensuring regulatory compliance. Also ensure continuous implementation of the Quality Management System in India.

• Supporting the Marketing Teams on Tender related issues
• Development, implementation and maintenance of regulatory systems pertaining to regulatory document management (SOP's, archival, trackers and systems) within the department and organization.
• Interface and coordinate with regulatory agencies/competent authorities (CDSCO, DGDA, State FDA etc.) with respect to submissions, obtaining registrations/licenses, amendments, regulatory compliance, packaging, quality control testing or release, etc.

What Makes You Stand Out

• Good communication and interpersonal skills
• Customer focused: Understands and delivers customer service
• Ability to quickly establish credibility with all levels of Regulatory Agencies, Government, etc.
• Good verbal and written communication skills in English - with colleagues, management and external authorities
• Self-motivated and positive "Can do" attitude. Can work autonomously but is also a team player
• Outgoing and friendly: Enthusiastic, energetic, diplomatic, willingness to learn
• Be able to plan, manage, organize and report in an efficient way
• Be independent, persuasive, innovative and able to summarize
• Good time management: Well organized, able to set and reset priorities

Your Background

• B Pharm / M Pharm / Bachelor or Master Degree in Bio-Medical Engineering / Science discipline with training in Regulatory Affairs
• Must have at least 2-3 years’ experience in the pharma/medical device/life science industry with at least 2 years' medical device experience in regulatory affairs
• Conversant with various regulatory requirements for India, Bangladesh, Pakistan & Nepal with respect to medical device registration, import, clinical trials, etc.
• Knowledge in application of CDSCO, FDA, CE and other regulatory requirements.

Travel Expectations