Regulatory Affairs Specialist @ Techno Endura

Job Description

Responsibilities:

• Prepare and submit regulatory documentation for new and existing medical products, including drugs, devices, and biologics.
• Stay up-to-date on ever-evolving regulatory requirements and guidelines.
• Liaise with regulatory agencies and respond to their inquiries.
• Manage the regulatory approval process from pre-clinical development to post-market surveillance.
• Develop and implement effective regulatory strategies to ensure timely market access for our products.
• Analyze and interpret complex scientific and regulatory data.
• Provide expert advice and guidance to internal teams on regulatory matters.
• Manage and maintain regulatory databases and tracking systems.
• Collaborate with cross-functional teams, including research and development, manufacturing, and marketing.

Qualifications:

• Bachelor's degree in science, healthcare administration, or a related field.
• Minimum of 0- 2 years of experience in regulatory affairs, preferably in the pharmaceutical, biotechnology, or medical device industry.
• Strong understanding of relevant regulatory guidelines (e.g., FDA, EMA, etc.).
• Excellent written and verbal communication skills.
• Ability to work independently and as part of a team.
• Meticulous attention to detail and strong organizational skills.
• Ability to prioritize and manage multiple tasks effectively.

Interested to apply can share Cv or call/whatsapp to hidden_mobile  

Employement Category:

Employement Type: Full time
Industry: Medical / Healthcare
Role Category: Medical / Healthcare
Functional Area: Not Applicable
Role/Responsibilies: Regulatory Affairs Specialist

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Keyskills:   regulatory requirements regulatory matters regulatory guidelines regulatory affairs healthcare compliance