Regulatory Affairs

2 months ago

Andhra Pradesh, India Virtusa Full time

Regulatory Affairs Specialist
Careers that Change Lives
Collaborate and partner with Design QA, R&D, Sustaining Engineering, Clinical Affairs, Marketing and Operations. Supports the Global Operating Unit Regulatory Affairs function as the local representative for ensuring requirements are met. Responsible for supporting the needs of the MEIC with regulatory support for research and development activities and ensuring Indian and other applicable regulations and policies are met.
A Day in the Life
Supporting Design and Development Control activities with regulatory requirements, direction, tactics and strategies and working in a team environment with all organizational departments.
Must Have
Job Responsibilities
Prepare, review, file, and support premarket documents for global registrations for assigned projects.
Collaborate with business unit and international regulatory affairs personnel to support marketing authorizations for assigned projects.
Represent Regulatory Affairs as team member of product development projects from Concept through Commercialization.
Review pre-clinical, and clinical protocols and associated reports to be used in submissions for assigned projects.
Develop Regulatory Strategies for new or modified products for assigned projects.
Monitor and provide information pertaining to impact of changes in the regulatory environment.
Communicate with regulatory agencies and/or notify bodies on administrative and routine matters.
Document, consolidate, and maintain oral and written communication with health authorities
Prepare internal documents for modifications to devices, when appropriate.
Participate in health agency inspections & notified body audits as necessary.
Author and/or review regulatory procedures and update as necessary.
Review change control documents and ascertain regulatory impact for external and internal documents through formal regulatory assessments.
Assist in development/maintenance of regulatory files, records, and reporting systems of systematic retrieval of information.
Review promotional material, advertising, and labeling to ensure regulatory compliance on assigned projects.
Ensure compliance to regulations specific to clearance and approvals of MEIC developed products raw material and/or prototype.
Minimum Qualifications
Bachelor degree in Medical, Mechanical, Electric Life Science or other healthcare related majors
4-7 years experiences for RA role in medical device and or pharmaceutical industry
Good understanding for regulations and policies issued by India, US FDA and EU, and ability to interpret international regulatory requirements.
Excellent written, organizational, and communication skills is required, and have a flexible and team-oriented attitude.
Strong attention to details and ability to handle multiple tasks, good at planning and can work under pressure;
Good at English, including reading, writing, and speaking;
Good Learning attitude
Nice to Haves
Excellent communication and interpersonal skills
Excellent written, organizational, and communication skills is required, and have a flexible and team-oriented attitude.
Self-motivated and positive
Ability to quickly establish credibility with all levels of customer base

**About Virtusa**

Teamwork, quality of life, professional and personal development: values that Virtusa is proud to embody. When you join us, you join a team of 30,000 people globally that cares about your growth — one that seeks to provide you with exciting projects, opportunities and work with state of the art technologies throughout your career with us.

Great minds, great potential: it all comes together at Virtusa. We value collaboration and the team environment of our company, and seek to provide great minds with a dynamic place to nurture new ideas and foster excellence.

Virtusa was founded on principles of equal opportunity for all, and so does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

  • Regulatory Affairs Executive

    5 months ago

    Noida, Uttar Pradesh, India Bhargava HR solution Full time

    This is a full-time on-site role as a Junior Regulatory Affairs Executive located in Noida. The Junior Regulatory Affairs Executive will be responsible for regulatory documentation, ensuring compliance with regulatory requirements, preparing dossiers, and managing regulatory affairs. **Qualifications**: Regulatory Documentation, Regulatory Requirements, and...

  • Regulatory Affairs Trainer

    5 months ago

    Noida, Uttar Pradesh, India Technoledge Eduresearch Pvt Ltd Full time

    **Company Description** Technoledge is an educational institution located in Noida. Our primary objective is to provide support for the development, coordination, implementation, and planning of educational programs. We offer a wide range of services including smart hybrid schools, engineering services, manpower solutions, skill development, e-learning...

  • Junior Regulatory Affairs Executive

    5 months ago

    Noida, Uttar Pradesh, India BHARGAVA HR SOLUTION Full time

    **Role Description** This is a full-time on-site role as a Junior Regulatory Affairs Executive located in Noida. The Junior Regulatory Affairs Executive will be responsible for regulatory documentation, ensuring compliance with regulatory requirements, preparing dossiers, and managing regulatory affairs. **Qualifications** - Regulatory Documentation,...

  • Regulatory Affairs Executive

    5 months ago

    Noida, Uttar Pradesh, India Florencia Healthcare Full time

    **JOB DISCRIPTION ( Drug regulatory affairs )** **1. Drug Regulatory Affairs - Job description** Ø Prepare CTD, ACTD Dossiers and file regulatory submissions Ø Perform assessments of new or revised products Ø Manage complaint documentation (including investigation and Ø closure) Ø Respond to inquiries from regulatory bodies Ø Should be...

  • Drug Regulatory Affairs Executive

    5 months ago

    Lucknow, Uttar Pradesh, India Lucent Biotech Ltd. Full time

    Lucent Biotech Limited company Hiring For **Drug Regulatory Affairs Executive.** **Regulatory affairs officers ensure the appropriate licensing, marketing and legal compliance of a range of pharmaceutical and medical products in order to control their safety and efficacy** As a regulatory affairs officer you'll be the crucial link between your company, its...

  • Drug Regulatory Affairs Executive

    5 months ago

    Lucknow, Uttar Pradesh, India Lucent Biotech Ltd. Full time

    Lucent Biotech Limited company Hiring For **Drug Regulatory Affairs Executive.** **Regulatory affairs officers ensure the appropriate licensing, marketing and legal compliance of a range of pharmaceutical and medical products in order to control their safety and efficacy** As a regulatory affairs officer you'll be the crucial link between your company, its...

  • Officer - Regulatory Affairs

    3 months ago

    Lucknow, Uttar Pradesh, India Geetank Pharmaceutical pvt ltd Full time

    Geetank Pharmaceutical Pvt. Ltd. URGENT REQUIREMENT MALE CANDIDATE. POST- OFFICER REGULATORY AFFAIRS RESPONSIBILITIES- 1.DOSSIER 2.REVIEW 3.QUERY SOLVED QUALIFICATION- B PHARMA EXPERIENCE - MIN 02 YEAR (QA, RA ) SALARY - 12 K TO 16 K OFFICE TIME -10:00AM TO 6:00 PM INTERVIEW TIME- 11:00 AM TO 5:00PM CALLING TIME -10:00AM TO 6:00PM PRIYANKA...

  • Agm - Regulatory Affairs & Nodal

    5 months ago

    Lucknow, Uttar Pradesh, India Vodafone Idea Full time

    Job Req ID: 44289- Location: Lucknow, IN- Function: Other- About: - Vodafone Idea Limited is an Aditya Birla Group and Vodafone Group partnership. It is India’s leading telecom service provider. The Company provides pan India Voice and Data services across 2G, 3G and 4G platform. With the large spectrum portfolio to support the growing demand for data and...

  • Regulatory Documentation

    6 months ago

    Noida, Uttar Pradesh, India Bhargava HR solution Full time

    job title-- regulatory documentation urgent requirement location - noida sector 63 This is a full-time on-site role as a Junior Regulatory Affairs Executive located in Noida. The Junior Regulatory Affairs Executive will be responsible for regulatory documentation, ensuring compliance with regulatory requirements, preparing dossiers, and managing...

  • Manager Clinical Affairs

    7 days ago

    uttar pradesh, India Medical Learning Hub Full time

    Clinical Affairs Manager Join the Future of Healthcare TC4A, a pioneer in democratizing healthcare innovations, is revolutionizing diagnostics with LightAI. We are seeking talented individuals to join our office in Noida and address one of healthcare’s biggest challenges, the overuse of antibiotics that leads to drug-resistant infections and costs...

  • Manager Clinical Affairs

    2 weeks ago

    uttar pradesh, India Medical Learning Hub Full time

    Clinical Affairs ManagerJoin the Future of HealthcareTC4A, a pioneer in democratizing healthcare innovations, is revolutionizing diagnostics with LightAI. We are seeking talented individuals to join our office in Noida and address one of healthcare’s biggest challenges, the overuse of antibiotics that leads to drug-resistant infections and costs billions...

  • Manager Clinical Affairs

    1 week ago

    uttar pradesh, India Medical Learning Hub Full time

    Clinical Affairs ManagerJoin the Future of HealthcareTC4A, a pioneer in democratizing healthcare innovations, is revolutionizing diagnostics with LightAI. We are seeking talented individuals to join our office in Noida and address one of healthcare’s biggest challenges, the overuse of antibiotics that leads to drug-resistant infections and costs billions...

  • Corporate Relations Manager

    5 days ago

    uttar pradesh, India Attero Full time

    Job Summary: We are seeking an experienced and dynamic Corporate Relations Manager to lead our government affairs and corporate relations efforts. The ideal candidate will be responsible for developing and maintaining relationships with policymakers, trade associations, and critical stakeholders to support and further our business goals. This role involves...

  • Regulatory Affairs Executive

    2 months ago

    Indore, Madhya Pradesh, India Fusion Market Research Full time

    **Responsibilities**: - ensure that a company's products comply with the regulations of the regions where they want to distribute them - keep up to date with national and international legislation, guidelines and customer practices - respond to queries from medical bodies like the Medicines and Healthcare products Regulatory Agency (MHRA) - collect, collate...

  • Drug & Cosmetic - Regulatory Affairs

    3 months ago

    Noida, Uttar Pradesh, India corpseed ites pvt ltd Full time

    Job Description: - CDSCO Registration for medical devices, Drug & Cosmetics as per the rules and standards. - Draft, review, submission and archival of other regulatory submissions (Query responses, corrections fillings, miscellaneous notifications regarding post registration regulatory lifecycle management) for Indian market. - Review of technical...

  • Drug Regulatory Affair Executive

    5 months ago

    Noida, Uttar Pradesh, India Florencia Healthcare Full time

    JOB DESCRIPTION: - Ø Prepare CTD, ACTD Dossiers and file regulatory submissions Ø A Bachelor’s/ Master degree in B. Pharma / M. Pharma Ø Perform assessments of new or revised products Ø Experienced with 1 Yrs should apply. Ø Good Communication skills Job Type-Fulltime contact no-8810226562 Pay: ₹15,000.00 - ₹25,000.00 per...

  • Legal Advisor

    5 months ago

    Vijayawada, Andhra Pradesh, India Nalanda Educational Institutions Full time

    **Job Description: Legal Advisor and Administrative Executive** **Position**: Legal Advisor and Administrative Executive **Location**: Vijayawada, Andhra Pradesh **Institution**: Nalanda Educational Institutions **About Us**: Nalanda Educational Institutions, comprising Nalanda Vidyaniketan, Bloomingdale International School, and Nalanda Degree College, is...

  • Tester

    5 months ago

    Ghaziabad, Uttar Pradesh, India ekant solutions Full time

    **Responsibilities**: - Collaborate with cross-functional teams, including software engineers, quality assurance, regulatory affairs, and product management - Perform verification and validation testing activities, including functional testing, integration testing, regression testing, and performance testing, to verify software tool requirements and...

  • Arya.ag | Company Secretary | uttar pradesh

    36 minutes ago

    uttar pradesh, India Arya.ag Full time

    Company Description Arya is India’s leading Agritech firm located in Noida. The company leverages technology to bridge the Last Mile in agriculture value chains, with a focus on helping farmers, aggregators, Farmer Producer Organisations, food processors, and end-user corporates reduce post-harvest losses. Arya's platform, Arya.ag, offers a comprehensive...

  • Company Secretary

    2 months ago

    uttar pradesh, India Arya.ag Full time

    Company DescriptionArya is India’s leading Agritech firm located in Noida. The company leverages technology to bridge the Last Mile in agriculture value chains, with a focus on helping farmers, aggregators, Farmer Producer Organisations, food processors, and end-user corporates reduce post-harvest losses. Arya's platform, Arya.ag, offers a comprehensive...