Regulatory Associate

6 days ago


Kochi, India Silmed Scientific Full time

We are hiring an experienced medical writer with experience in CTD medical writing and experience in clinical development of medicines.

**Responsibilities**:

- Writing high quality CTD modules nonclinical and clinical overviews & summaries (Module 2.5, 2.4, 2.7, 2.7) as per requirements in EU submission
- Response to clinical deficiencies
- Assist with drug development strategy
- SmPC, Patient information leaflet, CCDS updates, Safety variations
- Clinical study reports, Study design and synopsis
- Assist in clinical development strategy Review of Study reports published papers
- Literature search and regulatory evaluation
- Rx to OTC evaluation
- PSURs, PADER, RMP

**Requirements**:

- MBBS in Medicine/ M.Pharma in Pharmacy/ Medical-MS/MD in Pharmacology/ Ph.D/Doctorate in Pharmacy
- Experience in Medical writing for regulatory submissions in Europe.
- Non-clinicaloverview / Clinical overview / PSUR / EU submission / ClinicalPharmacology / module 2.5 /Scientific Writing ICH / Regulatory Submissions / Medicine / DCP / CTD / Clinical Research / medical writer / Medical Writing / EMA labelling Module 2.4
- Scientific accuracy
- Attention to details
- Experience in Clinical study design and protocol
- Excellent communication skills and time management
- Specialization in Pharmacology desired.



  • Ahmedabad, Kochi, Kolkata, India Airvin Skills Full time ₹ 2,00,000 - ₹ 6,00,000 per year

    Job Type- Fresher or Internship levelClinical Research Associates manage clinical trials and studies pertaining to biotechnological and pharmaceutical products, drugs and procedures. A Clinical Research Associate, also known as a CRA, conducts research to ensure these products are safe.Responsibilities:Assist in Protocol Development:Collaborate with the...


  • Kochi, India Redux Full time

    This role involves the preparation and maintenance of financial statements in conformity with the Generally Accepted Accounting Principles of the United States (U.S. GAAP). The primary responsibilities include overseeing the day-to-day accounting processes and reviewing the accuracy of the monthly, quarterly, and annual financial statements. Additionally,...


  • Kochi, India Conduent Full time

    About Conduent: Through our dedicated associates, Conduent delivers mission-critical services and solutions on behalf of Fortune 100 companies and over 500 governments - creating exceptional outcomes for our clients and the millions of people who count on them. You have an opportunity to personally thrive, make a difference and be part of a culture where...


  • Kochi, India Conduent Full time

    Through our dedicated associates, Conduent delivers mission-critical services and solutions on behalf of Fortune 100 companies and over 500 governments - creating exceptional outcomes for our clients and the millions of people who count on them. - You have an opportunity to personally thrive, make a difference and be part of a culture where individuality is...


  • Kochi, Kerala, India Redux Full time

    This role involves the preparation and maintenance of financial statements in conformity with the Generally Accepted Accounting Principles of the United States U S GAAP The primary responsibilities include overseeing the day-to-day accounting processes and reviewing the accuracy of the monthly quarterly and annual financial statements Additionally the...


  • Kochi, Kerala, India Redux Full time

    This role involves the preparation and maintenance of financial statements in conformity with the Generally Accepted Accounting Principles of the United States of America U S GAAP The primary responsibilities include overseeing the day-to-day accounting processes and reviewing the accuracy of the monthly quarterly and annual financial statements Additionally...

  • Junior Associate

    1 week ago


    Kochi, India Chris Johnson Business IT Solutions Full time

    **Responsibilities**: - Assist senior team members in preparing reports, presentations, and proposals for clients and internal stakeholders. - Collaborate with cross-functional teams to provide support on various projects and initiatives. - Provide administrative support, including managing schedules, organizing meetings, and handling documentation. - Stay...


  • Kochi, Kerala, India Analytix Fintech International Pvt Ltd Full time

    **Responsibilities include: - ** - Knowing memorandum of association & Article of Association. - Handling licensing work in different portals. - Communicating with clients to address their queries. - Offering advice to clients regarding their business activities and company names. - Managing company takeover processes and related documentation. - Providing...

  • Executive-gdc

    6 days ago


    Kochi, India KPMG Full time

    **Executive-GDC** **-** **(** **22000CHN** **)** **Description** **KPMG Global Delivery Center** KPMG Global Delivery Center (GDC) is a robust global delivery platform comprising a talent pool of over 1,700 professionals in Bangalore and Kochi. GDC provides Audit & Advisory professional services to KPMG US & Canada while complying with both regulatory and...


  • Kochi, India JOBS n TA HR Services Full time

    Roles and Responsibilities: •    Manage the insurance business from assigned bank branches. •    Develop strong relationships with bank staff to generate insurance leads. •    Conduct joint calls with bank staff to explain and promote insurance solutions to customers. •    Meet sales targets by cross-selling and upselling insurance...