Regulatory & Compliance Associate. Skyleaf consultants

Skyleaf Consultants -
Mumbai, Maharashtra

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Job details

Full-time
₹8,00,000 - ₹10,00,000 a year

Qualifications

Law
Biotechnology
Research
Communication skills
FDA regulations

Full job description

Skyleaf Consultants

Highlights:

5.00 - 10.00 Years

8.00 - 10.00 INR (Lacs)/Yearly

Full-time

Mumbai

Roles & Responsibility

Key Responsibilities:1. Regulatory Compliance for NPD:o Assist in researching and understanding regulatory requirements for new productdevelopment (NPD) in domestic and international markets.o Help compile and prepare documentation for product registrations, ingredientapprovals, and certifications.o Collaborate with R&D and product development teams to ensure regulatoryguidelines are integrated into product design and formulation.
2. Intellectual Property & Legal:
o Support in conducting preliminary research on Intellectual Property (IP) protection,including patents, trademarks, and copyright registrations.o Assist in the preparation and submission of patent applications and trademarkfilings.o Maintain records of all active IPs, including timelines and renewal dates.3. Clinical Tests & Safety Protocols:o Work closely with the Compliance Manager to track and document clinical testsconducted in partnership with third-party organizations.o Review and organize Double Blind Placebo and other efficacy tests results,maintaining detailed reports for internal review and external audits.
4. Packaging Safety & Labelling:o Assist in verifying the compliance of product packaging with safety standards andlabeling regulations in all relevant markets.o Check that claims made on packaging are compliant with regulatory standards andsupported by research or testing results.
5. Documentation & Reporting:o Help prepare compliance reports and regulatory submissions as required.o Maintain accurate records of ongoing and completed compliance projects.6. Cross-functional Collaboration:o Coordinate with legal, marketing, and R&D teams to ensure alignment of complianceand regulatory efforts with business objectives.o Participate in cross-functional meetings to learn about the intersections of NPD,regulatory compliance, and marketing strategies.

Requirements

Key Skills and Qualifications:• Educational Background: Degree in Law, Pharmaceutical Sciences, Biotechnology, CosmeticScience, Regulatory Affairs, or a related field.• Experience: 5 to 6 years of relevant experience in regulatory compliance, intellectualproperty, or a related function, preferably within the cosmetics, pharmaceutical, or FMCGsector.• Knowledge Base: Basic understanding of regulatory frameworks (FDA, Ecocert, etc.) andintellectual property protection principles.• Communication Skills: Strong written and verbal communication skills.• Attention to Detail: High attention to detail with a proactive approach to identifying andresolving potential compliance issues.• Research Skills: Ability to conduct research and analyze regulatory guidelines, marketstandards, and legal documents.

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Highlights:

Roles & Responsibility

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