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Sr. Executive- Dra

Evolet
5-6 years
Not Disclosed
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