Regulatory Affairs Associate

5 days ago

Hyderabad, Telangana, India Corteva Agriscience Full time ₹ 5,00,000 - ₹ 8,00,000 per year

Regulatory to Operations (R2O) Associate (This is a contract position on the payroll of a 3rd party Vendor)

Job Description

The R2O Associate is accountable for processing regulatory documents required for product registrations globally. This role requires cross functional interaction with teams across multiple technical disciplines. Candidates should be results oriented and organized with a proven ability to work effectively within a centralized team environment as well as independently.

Responsibilities

o Coordinates global regulatory document preparation and delivery working closely with Country Regulatory Managers (CRMs), subject matter experts, manufacturing, and Global Regulatory Teams.

o Works closely with Country Regulatory Managers to understand the local requirements of the document requests.

o In some cases, this is done as part of a broader supply project team which will also require project management of requests, timelines, and prioritization to achieve project objectives.

o Utilizes the tracking tool for metrics.

o Executes the delivery of documents to the CRMs and archives a copy of the documentation for future reference and traceability.

o Monitors requests to ensure follow up and processing is completed in a timely fashion to meet business requirements.

o Ensures communication of project status to key stakeholders.

o Proactively reaches out to appropriate subject matter experts, global, regional, or country regulatory staff, or operations as needed to understand and implement specific requirements for document requests.

o Independently manages shifting priorities based on requests and document timelines.

o Participates in team meetings and effectively communicates with global regulatory and business staff.

o Champions continuous improvement within the team.

o Leads and/or participates in other projects or process improvement efforts as needed.

Qualifications

Minimum BS degree in information, chemistry, biology or related scientific field (or equivalent experience).

Proficient using MS Excel, Word, PowerPoint, and SharePoint as well as familiarity with database environments.

Excellent project management, organization, written and oral communication skills.

Previous technical or regulatory experience desired.

Should have experience in SAP EHS module

  • Regulatory Affairs Associate

    1 week ago

    Hyderabad, Telangana, India Vipsa Talent Solutions Full time US$ 60,000 - US$ 1,20,000 per year

    Regulatory Affairs AssociateExperience: 3-6 yearsEducation: Science GraduateLocation: HyderabadSkills: Regulatory Affairs, EU market, Formulation, RA, European market, Post and Pre approval

  • Regulatory Affairs CMC Associate

    6 days ago

    Hyderabad, Telangana, India Ztek Consulting Full time

    Job Description – Regulatory Affairs CMC Associate (US Market)We are seeking a Regulatory Affairs Associate to support US FDA submissions and lifecycle management activities.Key Responsibilities:- Prepare, review, and compile regulatory submissions (ANDAs, NDAs, supplements, amendments, deficiency responses, annual reports, PADER) in eCTD format.- Maintain...

  • Regulatory Affairs CMC Associate

    5 days ago

    Hyderabad, Telangana, India Ztek Consulting Full time

    Job Description – Regulatory Affairs CMC Associate (US Market)We are seeking a Regulatory Affairs Associate to support US FDA submissions and lifecycle management activities.Key Responsibilities:Prepare, review, and compile regulatory submissions (ANDAs, NDAs, supplements, amendments, deficiency responses, annual reports, PADER) in eCTD format.Maintain...

  • Regulatory Affairs Specialist: Artwork Management and Compliance

    1 week ago

    Hyderabad, Telangana, India beBeeregulatory affairs officer Full time ₹ 40,00,000 - ₹ 80,00,000

    Job Summary:","Regulatory Affairs Specialist: Artwork Management and Compliance"],

  • Regulatory Affairs

    1 week ago

    Hyderabad, Telangana, India Clininfotech Full time ₹ 1,04,000 - ₹ 1,30,878 per year

    We are seeking a Regulatory Affairs Executive Freshers To Work in the MNC For Hyderabad LocationThe ideal candidate should have hands-on experience in compiling and reviewing ACTD and CTD dossiers for various regulatory submissions. Required Candidate profileB.Pharm & M.Pharm With Knowledge of Regulatory Affairs CTD ECTD DMF and Regulatory Guidelines are...

  • Regulatory Affairs Sr Associate

    1 day ago

    Hyderabad, Telangana, India Amgen Full time ₹ 4,00,000 - ₹ 8,00,000 per year

    The Senior Associate in Regulatory Affairs at Amgen plays an important role in ensuring that the company's products meet and maintain regulatory standards. They assist in preparing submissions for regulatory agencies, keep updated on changes in regulatory legislation, and guide various teams within the company to ensure compliance with applicable...

  • Senior Regulatory Affairs Professional

    2 weeks ago

    Hyderabad, Telangana, India beBeeregulatory Full time ₹ 18,00,000 - ₹ 24,00,000

    Regulatory Affairs Senior AssociateWe are seeking a seasoned Regulatory Affairs professional to join our team as a Senior Associate. This role will involve assisting in the development and implementation of regulatory strategies across all product brands.Preparation, tracking, reporting, and archiving US regulatory documentationManagement of Ad Promo...

  • Regulatory Affairs CMC

    1 week ago

    Hyderabad, Telangana, India Vipsa Talent Solutions Full time ₹ 6,00,000 - ₹ 12,00,000 per year

    Regulatory Affairs CMCExperience: 6-11 yearsEducation: Science GraduateLocation: HyderabadSkills: Regulatory Affairs, US market, CMC

  • Regulatory Affairs Expert

    2 weeks ago

    Hyderabad, Telangana, India beBeeRegulatory Full time US$ 1,54,000 - US$ 2,41,300

    Regulatory Affairs ExpertThe Regulatory Affairs Manager is responsible for leading the execution and coordination of global regulatory activities.Key Responsibilities:Develop and execute strategic plans for global and country-specific regulatory complianceProvide CMC regulatory strategy by defining filing requirements, submission strategies, and risk...

  • Senior Regulatory Affairs Professional

    7 days ago

    Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 20,00,000 - ₹ 25,50,000

    Regulatory Affairs Associate Manager Job DescriptionWe are seeking a highly skilled Regulatory Affairs Associate Manager to lead our team in Hyderabad, India. The successful candidate will be responsible for regulatory activities related to chemistry, manufacturing, and control (CMC).Main Responsibilities:Author high-quality global CMC documentation for...