Senior Associate

2 weeks ago

India ClinChoice Full time ₹ 5,00,000 - ₹ 10,00,000 per year

Regulatory Consultant (EU OTC)

Responsibilities:

Submission support:

  • Submission management support for MRP & DCP procedures, PSUSA submission, Renewals, Repeat use procedures, variations etc.
  • Preparation and compilation of regulatory documentation for the registration, variation and renewal of OTC drugs for EMEA.
  • Prepare cover letter, application form and relevant Module 1 documents for variations.
  • Manage regulatory action item (task) tables including mapping, coordination of regulatory inputs, and timing.
  • Work with regulatory team to develop project implementation plans and manage workload planning to ensure on-time completion of projects and tasks.
  • Regulatory review of submission documents for compliance.
  • Work with cross-functional teams or local affiliates for submission documents and verification of packages.
  • Updating relevant submission tracker.

PSUR submission support:

  • Review of EURD updates
  • Tracking licenses for DLP and PSUR submission.
  • Review of draft PSUR document for accuracy of the data.
  • Co-ordinate with different stakeholders for safety related information for PSUR
  • Support submission and handling of queries for PSUR

Renewal support:

  • Tracking of licenses for registration and approval.
  • Tracking of approval validity of licenses and renewal timelines.
  • Planning for renewal submission.
  • Co-ordination with cross-functional team for Renewal documentation.
  • Co-ordination with Local RA lead for Renewal documentation and submission.
  • Preparation of Renewal package.
  • Submission of Renewal to health authority and post submission activity.

Deliverables:

  • Provide weekly updates (at a minimum or based on client requirement) to relevant colleagues or Project Manager on project status. Internal & Confidential [not for external circulation]
  • Ensure that regulatory standards and timelines are met for all projects.
  • Planning and tracking the status of ongoing regulatory projects
  • Use of regulatory database and IT tools where relevant.
  • Project review every quarter on performance feedback and scope of improvement.

Experience/Qualifications:

  • Minimum B.S. Chemistry, Biology, or related fields
  • Minimum of 4-5 years of experience working within a Regulatory Affairs Department (e.g., pharmaceutical, cosmetic, food supplements, etc.), with direct accountability for deliverables or a combination of direct Regulatory Affairs experience and specific interactions with a Regulatory Affairs Department by providing source documentation to CMC, Quality, or Regulatory Operations.

  • Senior Associate

    2 days ago

    Noida, India Tavasya Legal, Advocates & Solicitors Full time

    Job Description WE ARE HIRING!! Tavasya Legal has an opening for a Senior Associate with 5+ years of experience. Role Description: This is a full-time on-site role for a Senior Associate located in Noida. The Senior Associate will be responsible for managing day-to-day legal activities including drafting and reviewing legal documents, providing legal...

  • IP Senior Associate

    1 week ago

    India Angel and Genie Full time

    Our client is one of the leading IP Law firms in India with offices in Gurgaon, Bangalore, Mumbai, Chennai and Hyderabad. In terms of its practice, our client provides service across all aspects of Intellectual Property rights including patents, plant varieties, designs, trademarks, copyright, geographical indications trade secrets and related matters. Our...

  • Senior Associate Credit

    2 days ago

    India Castellan Real Estate Partners Full time

    Job Description: Senior Associate Credit Location: Remote – India Working Hours: Eastern Standard Time (US) About the Role We are seeking a motivated and detail-oriented Senior Associate Credit to join our team and strengthen our credit and deal execution capabilities. The successful candidate will have 7-8 years of relevant credit experience and will...

  • Senior Associate Credit

    1 week ago

    India Castellan Real Estate Partners Full time

    Job Description: Senior Associate CreditLocation: Remote – IndiaWorking Hours: Eastern Standard Time (US)About the RoleWe are seeking a motivated and detail-oriented Senior Associate Credit to join our team and strengthen our credit and deal execution capabilities. The successful candidate will have 7-8 years of relevant credit experience and will work...

  • Audit & Assurance: Senior Associate/Senior

    2 weeks ago

    India AKM Global Full time

    Job Description Audit & Assurance: Senior Associate/Senior - US GAAP, UK GAAP, IFRS, FRS 102 Our Audit & Assurance team is one of the growing teams in our office. As part of our team, you will provide our clients' your valuable inputs by using your skills and experience to give companies, investors, and regulators confidence in the validity of financial...

  • Audit & Assurance: Senior Associate/Senior

    3 days ago

    India AKM Global Full time

    Job Description Audit & Assurance: Senior Associate/Senior - US GAAP, UK GAAP, IFRS, FRS 102 Our Audit & Assurance team is one of the growing teams in our office. As part of our team, you will provide our clients’ your valuable inputs by using your skills and experience to give companies, investors, and regulators confidence in the validity of...

  • Senior Associate Compliance Risk Specialist

    2 weeks ago

    India beBeeCompliance Full time ₹ 15,00,000 - ₹ 25,00,000

    Job OverviewA highly skilled Senior Associate Compliance Risk Services professional is sought to assist in conducting Compliance Quality Assessment Reviews and supporting Managers in identifying areas for improvement and implementing corrective actions.

  • Senior Associate, Data

    1 week ago

    India Weber Shandwick Full time

    Role: Senior Associate Designation: Senior Associate – Client Experience Reporting to: Manager – Client Experience Part of The Weber Shandwick Collective, we're the earned-first global communications agency, led by world-class strategic thinkers and creative activators. We energize the right mix of talent, using the right platforms and latest...

  • Audit & Assurance: Senior Associate/Senior

    2 days ago

    India AKM Global Full time

    Job DescriptionAudit & Assurance: Senior Associate/Senior - US GAAP, UK GAAP, IFRS, FRS 102Our Audit & Assurance team is one of the growing teams in our office. As part of our team, you will provide our clients’ your valuable inputs by using your skills and experience to give companies, investors, and regulators confidence in the validity of financial...

  • Audit & Assurance: Senior Associate/Senior

    2 days ago

    India AKM Global Full time

    Job Description Audit & Assurance: Senior Associate/Senior - US GAAP, UK GAAP, IFRS, FRS 102 Our Audit & Assurance team is one of the growing teams in our office. As part of our team, you will provide our clients’ your valuable inputs by using your skills and experience to give companies, investors, and regulators confidence in the validity of financial...