Senior Manager Regulatory Surveillance

10-15 years

Not Disclosed

Vadodara

10 Dec. 25, 2024

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Regulatory Surveillance Manager/Sr. Manager

Location: [Location TBD]

Job Summary:

The Regulatory Surveillance Manager/Sr. Manager will be responsible for continuously monitoring, analyzing, and implementing new or modified regulatory guidance documents. The role ensures that the organization remains compliant with all applicable regulatory standards and that any changes to regulations are effectively integrated into the company's operations.

Key Responsibilities:

Regulatory Tracking and Analysis:
- Continuously track new and updated regulatory guidance, standards, and regulations from global regulatory agencies such as USFDA, EMA, WHO, MHRA, HC, CDSCO, etc.
- Analyze and interpret regulatory changes to assess their potential impact on company operations, products, and services.
Compliance Implementation:
- Develop and execute plans to implement new or modified regulations across the organization, ensuring compliance deadlines are met.
- Circulate regulatory updates to relevant departments, providing clear guidance on necessary policy adjustments, procedures, or product documentation.
Cross-Functional Collaboration:
- Collaborate closely with Quality Assurance, Regulatory Affairs, Operations, and R&D to ensure compliance is integrated into daily operations and product lifecycle management.
- Provide expert advice on regulatory compliance during the development and manufacturing stages.
Risk Assessment and Mitigation:
- Evaluate compliance risks associated with new regulatory changes and propose appropriate mitigation strategies where necessary.
Documentation and Reporting:
- Maintain detailed records of regulatory updates, impact assessments, and implementation efforts.
- Generate regular reports to communicate the status of compliance efforts to senior management and regulatory authorities, as required.
Audit and Inspection Support:
- Assist in preparing for regulatory audits and inspections by ensuring all relevant documentation and processes are compliant with the latest regulatory requirements.

Qualifications:

Education:
- Master’s or Bachelor’s degree in Regulatory Affairs, Quality Assurance, Life Sciences, Pharmaceutical Sciences, or a related field.
Experience:
- Minimum of 10-15 years of experience in regulatory surveillance, compliance, or a related field, within the pharmaceutical, medical devices, or biotechnology industries.
- Proven experience working with global regulatory frameworks such as FDA, EMA, WHO, ICH, etc.
Skills:
- Strong understanding of global regulatory frameworks and their application.
- Excellent communication skills, with the ability to collaborate across multiple departments.
- Experience in preparing for regulatory audits and inspections, ensuring compliance with regulations.
- Proficiency in regulatory monitoring tools and databases to track regulatory updates and ensure compliance.

Preferred Skills:

Industry Experience:
- Experience in pharmaceuticals, medical devices, or biotechnology industries.
Project Management:
- Strong project management skills with the ability to handle multiple regulatory initiatives simultaneously.

Why Join Us?

This role offers an exciting opportunity for an experienced regulatory professional to ensure the organization stays ahead of regulatory requirements. You will be a key player in ensuring compliance, minimizing risks, and supporting the company’s mission in a rapidly evolving regulatory landscape.

Apply today to be a part of an organization committed to operational excellence and global compliance!

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Senior Manager Regulatory Surveillance

Job Description

Job Title: Regulatory Surveillance Manager/Sr. Manager

Job Summary:

Key Responsibilities:

Qualifications:

Preferred Skills:

Why Join Us?

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