What are the responsibilities and job description for the Regulatory Affairs Manager position at CSL Plasma?
About the Role
CSL Plasma is seeking a highly skilled and experienced Regulatory Affairs Manager to join our team. As a Regulatory Affairs Manager, you will be responsible for ensuring that our plasma collection operations are conducted in accordance with applicable laws, regulations, and company policies.
Key Responsibilities
- Develop and maintain relationships with regulatory agencies, including FDA, OHSA, and other relevant authorities.
- Stay up-to-date with changes in regulations and laws affecting our business, and implement necessary updates to our procedures and policies.
- Collaborate with management to develop and implement corrective action plans in response to regulatory issues.
- Ensure center records are accurate, complete, and compliant with regulatory requirements.
Your Skills and Experience
- Minimum 3 years' experience in a regulatory affairs role, preferably in a healthcare or pharmaceutical industry.
- Strong knowledge of regulatory requirements, including cGMP, OHSA, FDA, and other relevant regulations.
- Excellent communication and interpersonal skills, with the ability to build strong relationships with colleagues and external stakeholders.
Working Conditions
- Occasional travel required to attend meetings and training sessions.
- Ability to work in a fast-paced environment with multiple priorities and deadlines.
- Strong organizational and time management skills, with the ability to prioritize tasks effectively.
About Us
CSL Plasma is a global leader in the collection and manufacture of plasma-derived therapeutics. We are committed to delivering high-quality products and services while maintaining the highest standards of safety and compliance.
CSL Plasma is seeking a highly skilled and experienced Regulatory Affairs Manager to join our team. As a Regulatory Affairs Manager, you will be responsible for ensuring that our plasma collection operations are conducted in accordance with applicable laws, regulations, and company policies.
Key Responsibilities
- Develop and maintain relationships with regulatory agencies, including FDA, OHSA, and other relevant authorities.
- Stay up-to-date with changes in regulations and laws affecting our business, and implement necessary updates to our procedures and policies.
- Collaborate with management to develop and implement corrective action plans in response to regulatory issues.
- Ensure center records are accurate, complete, and compliant with regulatory requirements.
Your Skills and Experience
- Minimum 3 years' experience in a regulatory affairs role, preferably in a healthcare or pharmaceutical industry.
- Strong knowledge of regulatory requirements, including cGMP, OHSA, FDA, and other relevant regulations.
- Excellent communication and interpersonal skills, with the ability to build strong relationships with colleagues and external stakeholders.
Working Conditions
- Occasional travel required to attend meetings and training sessions.
- Ability to work in a fast-paced environment with multiple priorities and deadlines.
- Strong organizational and time management skills, with the ability to prioritize tasks effectively.
About Us
CSL Plasma is a global leader in the collection and manufacture of plasma-derived therapeutics. We are committed to delivering high-quality products and services while maintaining the highest standards of safety and compliance.
