Regulatory Associate

3 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.


  • Junior Associate

    2 days ago


    Kochi, India PJ LAW OFFICES Full time

    About Us: PJ Law is a boutique corporate law firm and our firm’s practice verticals include: - Financial Restructuring & Corporate Insolvency - FinTech & Banking - Investment Funds, Investments, M&A & Debt - Employment Law - Intellectual Property - Litigation, Arbitration & Dispute Resolution - Maritime Law - Regulatory & Compliance Role: This is a...

  • Junior Associate

    4 days ago


    Kochi, India PJ LAW OFFICES Full time

    About Us:PJ Law is a boutique corporate law firm and our firm’s practice verticals include:Financial Restructuring & Corporate InsolvencyFinTech & BankingInvestment Funds, Investments, M&A & DebtEmployment LawIntellectual PropertyLitigation, Arbitration & Dispute ResolutionMaritime LawRegulatory & ComplianceRole:This is a full-time, on-site position for a...

  • Junior Associate

    3 days ago


    Kochi, India PJ LAW OFFICES Full time

    About Us:PJ Law is a boutique corporate law firm and our firm’s practice verticals include:Financial Restructuring & Corporate InsolvencyFinTech & BankingInvestment Funds, Investments, M&A & DebtEmployment LawIntellectual PropertyLitigation, Arbitration & Dispute ResolutionMaritime LawRegulatory & ComplianceRole:This is a full-time, on-site position for...


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

    _**Requirements: - **_ - LLB- Fresher or experienced, Pursuing CS (Company Secretary) or MBA/M.COM or commerce background. - Licensing and Compliance Associate with legal knowledge and licensing experience ( If Possible). - Ability to help with filings, give advice to clients, and handle company secretarial/ legal/licensing tasks. - Strong analytical and...


  • Kochi, India ANSR Full time

    ANSR is hiring for one of its clients.About Arch:Arch Capital Group Ltd. (Arch) is a leading global insurer with operations in more than a dozen countries. We write insurance, reinsurance and mortgage insurance on a worldwide basis, and our customers value us as an innovative partner and dependable risk manager with decades of fresh ideas and solid results....


  • Kochi, India Analytix Full time

    Senior Associate - Audit Take full responsibility for finalizing accounts and independently executing client audits.- Lead and mentor audit teams to ensure accuracy, completeness, and high-quality deliverables.- Plan, schedule, and conduct audits of financial and operational processes, ensuring compliance with relevant laws, regulations, and internal...


  • Kochi, Kerala, India Advenxa Pvt.Ltd Full time

    **Junior Claims Associate** Location**: Infopark,Kochi** Experience**:* Minimum**6 months **to**1 **year in**US Insurance Claims Support* Salary **:Rs. 20000/ - Rs. 25000/**Per Month Qualification**:Graduation**(B.Tech is not Eligible) Shift**:*6 PM- 3 AM* Working Days**:Monday - Friday** **Responsibilities**: - Analyze loan transactions and assess...


  • 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...


  • Kochi, India UST Full time

    Role Proficiency: Leverage expertise in a technology area (e.g. Infromatica Transformation Terradata data warehouse Hadoop Analytics) Responsible for Architecture for a small/mid-size projects. Outcomes: - Implement either data extract and transformation a data warehouse (ETL Data Extracts Data Load Logic Mapping Work Flows stored procedures data...


  • Kochi, India Conduent Business Services 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...