Regulatory Affairs Lead

Roles and responsibilities

As a Junior Regulatory Affairs Coordinator, you will play a vital role in supporting the regulatory functions of our organization. You will assist in ensuring compliance with all applicable regulations and guidelines governing our products, which may include pharmaceuticals, medical devices, or other healthcare-related products. This entry-level position is ideal for someone looking to start a career in regulatory affairs and make a meaningful impact on product safety and efficacy.

Key Responsibilities:

1. Documentation and Submission:

   • Assist in the preparation and submission of regulatory documents to relevant health authorities.
   • Ensure that all submissions comply with industry standards and regulations.
   • Maintain accurate records of all regulatory documents, correspondence, and submissions.

2. Regulatory Research:

   • Conduct research on regulatory requirements and guidelines relevant to our products and markets.
   • Stay updated on changes in regulations, guidelines, and industry practices to ensure compliance.

3. Collaboration:

   • Work closely with cross-functional teams, including R&D, Quality Assurance, and Marketing, to gather necessary information for regulatory submissions.
   • Collaborate with senior regulatory staff to address regulatory inquiries and provide support during audits and inspections.

4. Compliance Monitoring:

   • Assist in monitoring and ensuring compliance with local, national, and international regulations.
   • Support the development and implementation of internal regulatory policies and procedures.

5. Training and Support:

   • Participate in training sessions to enhance your understanding of regulatory processes and requirements.
   • Provide support to internal teams regarding regulatory queries and best practices.

Desired candidate profile

Qualifications:

• Bachelor’s degree in Life Sciences, Pharmacy, or a related field.
• Previous experience or internships in regulatory affairs, quality assurance, or a related area is a plus but not required.
• Strong analytical and organizational skills, with attention to detail.
• Excellent written and verbal communication skills.
• Ability to work collaboratively in a fast-paced environment.

  Skills:

• Excellent written and Verbal communication skills with the ability to listen, articulate and advocate.
• Proactive, high performance, result oriented, and manage projects with ethical integrity.
• Technical system skills (e.g., MS office applications, databases, efficient online research).
• Manage multiple projects and deadlines.

What We Offer:

• Competitive salary and benefits package.
• Opportunities for professional development and career advancement.
• A supportive and dynamic work environment.

Join our team and contribute to the development of safe and effective products that improve health outcomes!