Are you a highly experienced and motivated individual with a passion for regulatory affairs? Are you looking for a challenging opportunity to lead and drive compliance within a dynamic and fast-paced organization? If so, then CVS Health has the perfect role for you! As the Senior Manager of Regulatory Affairs, you will play a critical role in ensuring our company's compliance with all applicable laws, regulations, and guidelines. We are seeking a detail-oriented and strategic leader who possesses exceptional communication and analytical skills, along with a deep understanding of the healthcare industry. If you are ready to take on a leadership position and make a significant impact on the regulatory landscape within our organization, then we want to hear from you. Join us in our mission to help people on their path to better health today!
- Develop and implement strategies to ensure compliance with all relevant laws, regulations, and guidelines.
- Monitor and analyze changes in regulatory requirements and advise the organization on potential impacts and necessary actions.
- Lead and manage a team of regulatory affairs professionals, providing guidance and support to ensure timely and accurate compliance across the organization.
- Collaborate with cross-functional teams to integrate compliance requirements into business processes and procedures.
- Conduct internal audits and assessments to identify potential areas of non-compliance and develop corrective action plans.
- Serve as the primary point of contact for regulatory agencies and participate in external audits and inspections.
- Develop and maintain relationships with key stakeholders, including regulators, industry associations, and internal business partners.
- Stay current on industry trends and best practices in regulatory affairs to continuously improve processes and procedures.
- Oversee the development and submission of regulatory filings and reports, ensuring accuracy and timeliness.
- Identify and mitigate potential risks and compliance issues through proactive monitoring and analysis.
- Communicate compliance requirements and updates to all levels of the organization, providing training and support as needed.
- Participate in the development and implementation of compliance policies, procedures, and training programs.
- Represent the organization in industry forums and working groups to influence regulatory policy and advocate for the company's interests.
- Drive a culture of compliance and ethics throughout the organization, promoting a strong commitment to regulatory compliance at all levels.
Bachelor's Or Advanced Degree In A Relevant Field Such As Pharmacy, Biology, Or Chemistry.
Minimum Of 8-10 Years Of Experience In Regulatory Affairs Within The Healthcare, Pharmaceutical, Or Biotech Industry.
Strong Understanding Of Fda Regulations And Guidelines, Including Experience With Ind, Nda, And Anda Submissions.
Proven Track Record Of Successful Interactions And Negotiations With Regulatory Agencies.
Demonstrated Leadership Skills, With Experience Managing A Team And Overseeing Multiple Regulatory Projects Simultaneously.
Risk Management
Quality Assurance
Project Management
Data Analysis
Clinical Research
Cross-Functional
Government Relations
Team Leadership
Regulatory compliance
FDA regulations
Policy Development
Pharmaceutical Industry
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
Interpersonal Skills
creativity
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Sr Mgr, Regulatory Affairs is between $130,000 to $180,000 per year. However, this can vary depending on factors such as location, company size, and years of experience. Some candidates may also negotiate for higher salaries based on their qualifications and expertise in the field.
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CVS Health Corp. engages in the provision of health care services. It operates trough the following segments: Pharmacy Services, Retail or Long Term Care, and Corporate. The Pharmacy Services segment offers pharmacy benefit management solutions. The Retail or Long Term Care segment includes selling of prescription drugs and assortment of general merchandise. The Corporate segment involves in providing management and administrative services.

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