A Regulatory Affairs Officer is responsible for ensuring that a company's products comply with the regulations and guidelines set by regulatory authorities. They play a crucial role in the pharmaceutical, medical device, and healthcare industries where strict compliance with regulations is essential. The Regulatory Affairs Officer will work closely with cross-functional teams to develop and implement regulatory strategies, manage submissions to regulatory authorities, and ensure compliance with current regulations and guidelines.

Responsibilities:

1. Collaborate with cross-functional teams to develop and implement regulatory strategies.
2. Prepare and submit regulatory documentation, such as product registration dossiers, to regulatory authorities.
3. Monitor and interpret changes in regulations and guidelines and assess their impact on the company's products.
4. Ensure compliance with local and international regulations and guidelines for product development, labeling, and advertising.
5. Participate in regulatory inspections and audits and assist in addressing any findings or recommendations.

Preferred Candidate:

1. Minimum of 1-7 years of experience in regulatory affairs in the pharmaceutical, medical device, or healthcare industries.
2. Strong knowledge of local and international regulatory requirements and guidelines.
3. Ability to interpret and apply complex regulations to product development and compliance activities.
4. Excellent communication and interpersonal skills to effectively collaborate with cross-functional teams and regulatory authorities.
5. Attention to detail and strong analytical skills to review and assess regulatory documentation.

Skills

• Knowledge of local and international regulatory requirements and guidelines
• Strong understanding of product development processes in pharmaceutical, medical device, or healthcare industries
• Experience with regulatory submissions and documentation
• Excellent communication and interpersonal skills
• Attention to detail and analytical skills