Regulatory Affairs Specialist AMICO Group

Posted on 18 Mar

Experience

2 - 7 Years

Job Location

United Arab Emirates - United Arab Emirates

Education

Bachelor of Science

Nationality

Any Nationality

Gender

Not Mentioned

Vacancy

1 Vacancy

Job Description

Roles & Responsibilities

Key Responsibilities:
Regulatory Compliance: Ensure that all products and processes comply with local, regional, and international regulations and standards. Stay informed about changes in regulatory requirements and communicate relevant updates to the organization.
Develop and implement strategies to ensure ongoing compliance with regulatory requirements.
Submission Management: Oversee the preparation and submission of regulatory documents to health authorities. Collaborate with cross-functional teams to gather necessary information for regulatory submissions and identifying the scope of registration plan and lead time required for implementation.
Ensure submissions are accurate, complete, and submitted on time.
Relationship Management:
Build and maintain positive relationships with regulatory agencies, key stakeholders, and industry associations. Represent the company in regulatory matters during interactions with health authorities.
Risk Assessment: Conduct risk assessments related to regulatory compliance and provide recommendations for risk.
mitigation strategies. Anticipate potential regulatory issues and develop proactive solutions.
Regulatory Strategy: Develop and execute regulatory strategies that align with business goals.
Provide regulatory input during product development and new product lunch.
Quality Management: Collaborate with quality assurance teams to ensure that quality systems and processes comply with regulatory requirements.

Desired Candidate Profile

  • Education - Bachelor s degree or equivalent, Masters preferred from a recognized University/College.
  • Experience - Minimum 2 years of work experience in a Pharmaceutical or Medical device instrustry in U.A.E
  • Skills - Knowledge of Regulatory affairs in U.A.E will be an added advantage.
  • Must be an U.A.E National with the Family book.

Company Industry

  • Medical
  • Healthcare
  • Diagnostics
  • Medical Devices

Department / Functional Area

  • Administration

Keywords

  • Regulatory Affairs Specialist

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AMICO Group

At AMICO, we believe in fostering a diverse and inclusive workplace. We recognize the value that different perspectives and experiences bring to our company.
As part of our commitment to diversity, we encourage applications from all individuals as part of our inclusive hiring practices.
This initiative is part of our broader diversity agenda aimed at creating a balanced and innovative workforce.

Read More

https://www.amicogroup.com/careers/available-positions.aspx?job_id=z5G7h3l6a1kMvyS65NP3c0I7KY_kYYT9z_aWVHh0iF8=