Sr. Executive- Dra

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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Sr. Executive- Dra

Job Description

Sr. Executive - Drug Regulatory Affairs (DRA)

Company Secretary & Legal

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