Current jobs related to Associate Director, Regulatory Affairs - India - Parexel

  • Formulation Regulatory Affairs

    2 months ago

    india Biocon Full time

    Role - Formulation Regulatory Affairs Role - US / Canada MarketLevel - Associate Manager / Manager - US Market Required Education/Exp: Experience Req.: 10 - 16 yrs.Qualification: - M.Sc. / M. Pharma.ResponsibilitiesHands on experience on preparation, review and submission of ANDA/ANDS in US Market, including Modules.Experience and knowledge on life cycle...

  • Manager Clinical Affairs

    1 week ago

    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

    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...

  • Senior Manager Regulatory Affairs

    7 days ago

    india Rubicon Research Limited Full time

    About Rubicon ResearchRubicon Research Limited is a fast-growing pharmaceutical formulations company delivering value to our customers and investors by developing, manufacturing, and marketing branded specialty and generic prescription pharmaceutical products in regulated markets.Our product portfolio comprises over 250 SKUs across more than 70 product...

  • Business Growth Associate

    7 months ago

    India Turacoz Full time

    **About Us** Turacoz is a medical communications company which provides customized and cost effective solutions for medical writing. The team of young, dynamic, and energetic professionals contribute to the core service spectrum which includes publication writing; clinical research and regulatory writing; print and digital marketing solutions; and medical...

  • Info Tech Project Manager_Regulatory Affairs

    4 weeks ago

    india Biocon Biologics Full time

    At BBL we leverage cutting-edge science, innovative tech platforms and advanced research & development capabilities to lower treatment costs while improving healthcare outcomes. Intentional curiosity and an innate entrepreneurial scientific spirit fuel our strong research pipeline of biosimilar molecules across diabetes, oncology, immunology, and other...

  • Professor / Associate Professor/ Assistant Professor

    2 months ago

    india SVKM's Narsee Monjee Institute of Management Studies (NMIMS) Full time

    Application Invited for the Post of Professor / Associate Professor / Assistant Professor at Shobhaben P.Patel School of Pharmacy & Technology Management, Mumbai Campus for Regulatory Affairs AreaJOB DESCRIPTION Professor / Associate Professor / Assistant Professor - SPPSPTM - Regulatory AffairsProfessorEssentialPh.D. in relevant discipline from reputed...

  • Regulatory Affairs Officer

    5 months ago

    India ProductLife Group Full time

    **Specific activities and responsibilities**: Australia / South Africa / Brazil and GCC experience **Required education**: Degree in relevant life science discipline **Required experience**: 2-4 years relevant experience for Australia / South Africa / Brazil and GCC experience **Required technical skills**: - Lifecycle maintenance experience - Providing...

  • Director - Academics

    1 month ago

    india AAFT Full time

    Job Title: Director - AcademicsLocation: AAFT, NoidaJob Overview:The Campus Director at AAFT, Noida will provide visionary leadership and operational management for the institution. This role is responsible for overseeing all academic, administrative, and student affairs functions to ensure the successful execution of the institution's mission. The Campus...

  • Quality Assurance Director

    6 days ago

    India KP Manish Global Ingredients Pvt. Ltd. Full time

    Position Overview: KP Manish Global Ingredients Pvt. Ltd. is seeking a strategic and visionary Quality Assurance Director to lead our quality assurance function. Reporting directly to the Chief Technology Officer, this role provides leadership, quality control expertise, and direction to ensure the highest standards of quality and compliance across all...

  • Rubicon Research Limited | Senior Manager Regulatory Affairs | india

    6 days ago

    india Rubicon Research Limited Full time

    About Rubicon Research Rubicon Research Limited is a fast-growing pharmaceutical formulations company delivering value to our customers and investors by developing, manufacturing, and marketing branded specialty and generic prescription pharmaceutical products in regulated markets. Our product portfolio comprises over 250 SKUs across more than 70 product...

  • Sales Research Associate I

    3 weeks ago

    India Imaging Endpoints Full time

    Job SummaryWe are seeking a highly skilled Sales Research Associate I to join our team at Imaging Endpoints. As a key member of our proposal and contract process, you will work closely with Business Development, Operations, Medical and Scientific Affairs, Finance, and Compliance and Regulatory Affairs to prepare, review, and negotiate proposals and change...

  • Sales Research Associate I

    4 weeks ago

    India Imaging Endpoints Full time

    Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO). We are passionately focused on our vision to Connect Imaging to the CureTM . Everything we do is aligned with this singular purpose. We work every day excited to advance imaging science, technology, and services to bring curative technologies to humankind. We...

  • Sales Research Associate I

    4 weeks ago

    india Imaging Endpoints Full time

    Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO). We are passionately focused on our vision to Connect Imaging to the CureTM. Everything we do is aligned with this singular purpose. We work every day excited to advance imaging science, technology, and services to bring curative technologies to humankind. We...

  • Public Policy

    1 month ago

    india airtel Full time

    Job Description –Public Policy & Regulatory Strategy TeamJob Title - Senior ManagerLocation - GurugramWHAT WILL YOU BE DOING?Regulatory Managers at Airtel are curious, problem-solvers and self-starters, working at a fast pace to design solutions with our customers and users in mind. At Airtel, the Regulatory team is responsible for development and...

  • Public Policy

    1 month ago

    india airtel Full time

    Job Description –Public Policy & Regulatory Strategy Team Job Title - Senior Manager Location - Gurugram WHAT WILL YOU BE DOING? Regulatory Managers at Airtel are curious, problem-solvers and self-starters, working at a fast pace to design solutions with our customers and users in mind. At Airtel, the Regulatory team is responsible for development and...

  • Company Secretary

    1 month ago

    india Unacademy Full time

    Roles & Responsibilities:To ensure that the business and affairs of the company are managed in accordance with its objectives contained in the articles of association and the provisions of the Companies Law.To ensure compliance of the provisions of Companies Law and rules made there-under and other statutes and by-laws of the company.Proper maintenance of...

  • Company Secretary

    1 month ago

    india Unacademy Full time

    Roles & Responsibilities: To ensure that the business and affairs of the company are managed in accordance with its objectives contained in the articles of association and the provisions of the Companies Law. To ensure compliance of the provisions of Companies Law and rules made there-under and other statutes and by-laws of the company. Proper maintenance...

  • Company Secretary

    1 month ago

    india Unacademy Full time

    Roles & Responsibilities: To ensure that the business and affairs of the company are managed in accordance with its objectives contained in the articles of association and the provisions of the Companies Law. To ensure compliance of the provisions of Companies Law and rules made there-under and other statutes and by-laws of the company. Proper maintenance...

  • Sales research associate i

    3 weeks ago

    India Imaging Endpoints Full time

    Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (i CRO). We are passionately focused on our vision to Connect Imaging to the Cure TM . Everything we do is aligned with this singular purpose. We work every day excited to advance imaging science, technology, and services to bring curative technologies to...

Associate Director, Regulatory Affairs

3 months ago

India Parexel Full time

About the job


When our values align, there's no limit to what we can achieve.


At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.


Key Responsibilities

  • Clinical Trial Regulatory Submissions : Over 15 years of relevant experience in clinical trial regulatory submissions.
  • Regulatory Leadership : Experience in managing clinical trial studies, serving as Regulatory Lead for global trials, with exposure to the European market.
  • Database Expertise : Proficiency in handling the CTIS database and submitting EU CTR and CDSCO is desirable.
  • Project Profitability : Monitor the profitability of multiple projects/programs through active involvement with project leads in preparing project plans and managing project budgets.
  • Revenue Recognition : Proactively avoid and resolve issues with revenue recognition.
  • Team Collaboration : Work within a team environment or individually based on project needs.
  • Mentorship : Provide guidance to project team members and act as a mentor to staff.
  • Issue Resolution : Work within broad project guidelines and lead issue and conflict resolutions.
  • Workload Management : Prioritize own workload and the workload of the project team to achieve project scope and objectives.
  • Efficiency Improvement : Capitalize on opportunities to improve project efficiency, results, or team performance and proactively take action.
  • Performance Management : Actively manage performance, including typical HR activities for direct reports (e.g., performance management forms, salary actions, bonuses, scorecards).
  • Staff Support : Provide input on staff to appropriate PC Members and support direct reports with the management of their staff.
  • Guidance and Accountability : Provide applicable guidance and support to staff to succeed and achieve key metrics; hold staff accountable to key metrics.
  • Staff Development : Facilitate staff development plans and coordinate with Strategic Resourcing staffing to ensure staff is utilized completely and appropriately to increase their expertise.
  • Skill Expansion : Collaborate with strategic resourcing to provide staff with opportunities to expand skill sets.
  • Recognition and Reward : Reward staff appropriately as needed.
  • Leadership and Mentoring : Provide leadership, coaching, mentoring, feedback, and role modeling to managers and extended staff to ensure quality and accuracy of services as well as achievement of key metrics.
  • Vision and Values Communication : Communicate and champion organizational vision and values.
  • Effective Communication : Regularly communicate with staff to assure effective two-way information flow (e.g., business updates, staff interests, issues, and/or concerns).
  • Consulting Services : Provide a full range of technical and/or business consulting services mainly in areas where policy or precedent is clear.
  • Self-Development : Define self-development activities to keep current within the industry (e.g., maintain membership in a relevant industry and/or scientific/technical association).
  • Project Efficiency : Capitalize on opportunities to improve project efficiency, results, or team performance and proactively take action.
  • Information Leverage : Leverage information from previous projects or other client work to efficiently complete assigned project activities and facilitate business decisions.
  • Quality Work : Produce quality work that meets the expectations of the client. Review the work of colleagues for content and quality to ensure client and PC expectations are met.
  • Strategy Development : Assess project issues and develop strategies to meet productivity, quality, and project goals and objectives.
  • Performance Management : Actively manage performance, including typical HR activities for direct reports (e.g., performance management reviews, salary actions, bonuses, scorecards)