Regulatory Affairs Officer

19 hours ago

Mumbai, India Agile Consultants Full time

**Job Code**:047/001/753

**Location**:Mumbai

**Salary**:Based on experience

**Industry**:Chemical Manufacturing

Our client is hiring an experienced Regulatory Affairs Officer who can provide guidance and support sites with the implementation of Raw Materials such as Lubricant Additives, Epoxy Paints & Coatings, Rubber/Carbon Black, Coating, Foam, and Adhesives compliant with FDA Quality System Regulations (QSR), and other applicable ISO standards including ISO13485, ISO14971.

**Responsibilities**:

- Ensuring consistency, completeness, and adherence to standards for all regulatory submissions.
- Maintain up-to-date knowledge of international and domestic regulatory requirements.
- Perform Regulatory Affairs activities ensuring compliance with FDA, and other regulatory updates on the latest changes.
- Liaising with the FDA and REACH or other regulatory authorities, to monitor the progress of regulatory submissions, respond to queries, and ensure that registration approvals are granted without undue delay.
- Manages the process for case analytics and implements new methodologies to identify patterns and trends concerning important regulatory topics.
- Review Engineering Change Requests, Document Change Requests, Labeling, Variances, and other Quality System documentation that requires regulatory review and approval to ensure compliance with national and international government regulations.
- Work with QA and Engineering in generating risk analysis, FMEA, and FTA reports.
- Update RA responsible quality system procedures as required (SQP/SOP).
- Guide, direct, and lead a team of regulatory professionals in the development of strategic plans and regulatory submissions.
- Provide teams with insight into changes in the regulatory environment, including updates on FDA enforcement letters, meetings, guidance documents, and policies.

**Job Requirements**:

- Minimum
**5 years working in Chemical Raw Material products** such
**as Lubricant Additives, Epoxy Paints & Coatings, Rubber/Carbon Black, Coating, Foam, and Adhesives within a regulatory affairs/ compliance environment.**
- Bachelor’s degree in Chemical engineering, Chemistry, or a similar discipline required.
- Ability and desire to progress and represent Acorn Regulatory in an exemplary manner.
- A professional with positive and proactive influencing skills.
- A strong and proactive team player who thrives on working in a local & international environment.
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