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    Sr. Executive- Dra

    Evolet
    5-6 years
    Not Disclosed
    Gurgaon
    10 Aug. 12, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Sr. Executive - Drug Regulatory Affairs (DRA)

    Location: Gurgaon/Gurugram and Roorkee, Uttarakhand
    Experience: 3 - 5 years
    Salary: Not Disclosed

    Job Description:

    • Compile dossiers (CTD & ACTD) for CIS, ASEAN, LATAM, and African countries.
    • Oversee the entire product registration process from start to finish.
    • Evaluate bioequivalence studies and clinical trials (preferred).

    Required Candidate Profile:

    • Knowledge of ICH guidelines.
    • Experience with regulatory registration in CIS, ASEAN, LATAM, and African countries.
    • Willingness to travel and meet with representatives from manufacturing plants.
    • Excellent communication and analytical skills.
    • Strong attention to detail, accuracy, and focus.
    • Self-motivated and enthusiastic.

    Perks and Benefits:

    • Health Insurance
    • Shuttle Facility
    • Fixed Office Timing
    • Career Growth, Training & Development

    To Apply: Send your CV to [Insert Contact Email]

    Company Secretary & Legal

    Location: Gurgaon/Gurugram
    Experience: 5 - 7 years
    Salary: Not Disclosed

    Roles and Responsibilities:

    • Manage statutory records and ensure secretarial compliance.
    • Stay updated on regulatory or statutory changes and apply them within the organization.
    • File annual/quarterly returns and forms as required by Company Law.
    • Handle ROC work, maintain statutory registers, and manage minutes of meetings for the Board, members, and committees.
    • Ensure compliance with Companies Act and other laws such as RBI, FEMA.
    • Knowledge of accounting and assistance with bookkeeping is an advantage.
    • Draft Non-Disclosure Agreements and other legal documents.
    • Liaise with legal and government authorities to resolve company matters.
    • Oversee company closure processes and manage investment and allotment of securities.
    • Maintain MIS for the Legal department and support intellectual property protection.
    • Assist foreign directors with visa filing and extensions, and advise on property transactions.

    Desired Candidate Profile:

    • Education: L.L.B + C.S.
    • Member of the Institute of Companies Secretaries of India.
    • 5 - 6 years of experience.
    • Strong organizational skills, attention to detail, and ability to handle multiple tasks in a fast-paced environment.
    • Excellent written and verbal communication skills, strong interpersonal abilities, and the capability to work independently and as part of a team.
    • Proficiency in Microsoft Word, Excel, and PowerPoint.
    • Flexibility to travel and work evenings if needed.
    • Knowledge of intellectual property protection and experience with commercial property transactions is highly appreciated.
    • UK corporate knowledge or practice is a plus.

    Perks and Benefits:

    • Health Insurance
    • Shuttle Facility
    • Fixed Office Timing
    • Career Growth, Training & Development

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