Manager Regulatory Affairs
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Job Location:
Monthly Salary:
Posted on:
13 hours ago
Vacancies:
1 Vacancy
Job Summary
JOB TITLE: Sr. Manager Regulatory/ Manager Regulatory.
DEPARTMENT: CQA
REPORTING TO: AGM CQA for 1-1.5 years as Freelancer or as Manager on full time role as per
below job description.
Job description
Lead Regulatory compliance program for the standardization of Ayurvedic nomenclature
across the Brands Artwork FDA Supplier specifications and the incoming raw materials
pack including its processing at supplier and our factory end.
The Ayurvedic Regulatory Expert is responsible for ensuring that all Ayurvedic products
comply with local and international regulations. This role involves preparing and
submitting regulatory documents staying updated on relevant laws and guidelines and
liaising with regulatory authorities to ensure smooth approval processes. The expert will
also play a key role in maintaining product quality and safety standards.
Ensure all Ayurvedic products comply with local and international regulatory
requirements.
Prepare review and submit regulatory documents for product approvals renewals and
variations.
Monitor changes in regulatory guidelines and ensure timely implementation of updates.
Work closely with the quality assurance team to ensure product safety and quality.
Ensure all product labels packaging and promotional materials meet regulatory
standards
Conduct regular audits and reviews to ensure ongoing compliance.
Collaborate with R&D manufacturing marketing and legal departments to ensure
regulatory requirements are met throughout the product lifecycle.
Provide regulatory guidance during product development and formulation stages.
Stay updated on the latest regulatory trends and developments in Ayurvedic medicine.
Provide training and guidance to internal teams on regulatory requirements and best
practices.
Conduct regulatory assessments of Ayurvedic raw materials and monitor and support
commercialization and marketing initiatives including safety and claims substantiation.
Technical Document Management through Digital Ways.
Reports to Platform Leader- CQA
Work closely with R&D Legal Brand and Operations team.
Collaborate with reporting managers in overall departmental activities.
Key Skills & Experience:
Bachelor’s/ Master’s degree in Ayurvedic discipline Pharmacy Regulatory Affairs or a
related field.
Minimum of 5-8 years of experience in regulatory affairs preferably in the Ayurvedic or
herbal products industry.
In-depth knowledge of local and international regulatory requirements for Ayurvedic
products.
Strong understanding of Ayurvedic principles and nomenclature.
Excellent organizational communication and interpersonal skills.
Attention to detail and the ability to manage multiple tasks and deadlines.
Knowledge of SAP.
Knowledge of MS office.
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
