Regulatory Affairs Specialist

3 years years

Preffered by Company

Hyderabad

5 June 3, 2024

Job Description

Job Type: Full Time Education: B.Pharm/M.Pharm/PharmD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position: Regulatory Affairs Specialist
Job ID: JOB026
Employment Type: Full-Time
Company: Vizen Life Sciences Pvt Ltd
Experience Required: 3 Years

About the Role:
The Regulatory Affairs Specialist will ensure that all products meet regulatory standards and compliance. This role involves close collaboration with various departments to prepare and manage regulatory documents and communications with regulatory agencies.

Key Responsibilities:

Prepare, review, and submit regulatory documentation to health authorities.
Ensure compliance with all applicable regulatory requirements and guidelines.
Coordinate and manage regulatory submissions and approvals.
Stay updated on regulatory changes and communicate these to relevant departments.
Liaise with regulatory agencies and respond to inquiries in a timely manner.
Provide regulatory strategies and advice to product development teams.
Monitor and interpret regulatory guidelines and industry standards.
Participate in regulatory audits and inspections.

Preferred Qualifications:

Bachelor’s degree in a scientific discipline such as Biology, Chemistry, or Pharmacy, or in a related field.
Minimum of 3 years of experience in regulatory affairs, preferably in the pharmaceutical, medical device, or biotechnology sector.
Strong knowledge of regulatory requirements and guidelines (e.g., EMA, ICH).
Excellent written and verbal communication skills.
High attention to detail and strong organizational skills.
Ability to work independently and as part of a team.
Proficiency in Microsoft Office Suite and familiarity with regulatory databases.

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Regulatory Affairs Specialist

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