Sr Executive - Regulatory Affairs

About the Company: MAISON D' AURAINE is a conglomerate with a portfolio of premium brands in hair, beauty, and personal care. We started our journey in 2014 by partnering and launching "Gkhair" in India and over the course of the last 10 years, we have cemented our position as the leader in this category servicing 15000 salons across 300 cities of India. Gkhair, pH, & Keune are our three primary brands today but we are launching many more exciting products and brands this year. The company's detailed logistics footprint, automated business practices, round-the-clock service support, innovative marketing strategies, and in-depth research have helped it establish a leadership position in the industry. MAISON D' AURAINE strives to nurture hair and skin care business experts in the country by providing world-class education and services in collaboration with global trendsetters and artists. The company has also set up its own state-of-the-art R&D & manufacturing facility in Gurgaon, India which focuses on innovating science behind beauty and curating homegrown brands coming out of India for global markets. Sustainability & clean beauty are the key principles driving innovation & development of new brands in the organization. The group also has a flourishing tech arm called "ALT tech" where the dynamic & talented team of engineers & product owners are developing new-age websites, digital commerce-focused marketplaces, android and Ios apps, ERP & CRM solutions for Beauty & other industries. Join us today to be a part of the New Age Beauty Revolution coming out of India! Key Result Areas (KRAs): Regulatory Compliance Management:

• Ensure Compliance: Manage and ensure compliance with all applicable drug control regulations, guidelines, and standards set by government agencies and regulatory bodies.
• Regulatory Requirements: Stay up-to-date with changes in regulatory requirements and ensure that the organization adapts to these changes on time.

• Product Registrations: Manage the preparation, submission, and tracking of product registration dossiers for new and existing drugs.
• Listing Approvals: Oversee the process for drug listings with regulatory authorities, ensuring timely approvals and compliance with regulatory standards.

• Submission Preparation: Prepare and review regulatory submission documents, including New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and other necessary filings.
• Documentation Accuracy: Ensure accuracy and completeness of regulatory documentation to avoid delays or rejections.

• Agency Interactions: Act as the primary point of contact with regulatory agencies, addressing queries, providing requested information, and negotiating approvals.
• Compliance Discussions: Facilitate discussions and maintain positive relationships with regulatory authorities to support ongoing and future compliance efforts.

• Strategic Planning: Develop and implement regulatory strategies that align with organizational goals and facilitate efficient product development and market entry.
• Risk Management: Identify and mitigate regulatory risks by developing strategies to address potential compliance issues.

• Cross-Functional Collaboration: Work closely with internal teams such as R&D, Quality Assurance, and Legal to ensure regulatory requirements are integrated into product development and operational processes.
• Training Programs: Develop and deliver training programs on regulatory requirements and compliance practices to internal staff.

• Audit Preparation: Prepare for and manage regulatory audits and inspections, ensuring that all necessary documentation and processes are compliant.
• Inspection Follow-Up: Address findings from audits and inspections, implementing corrective actions as required.

• Market Intelligence: Monitor and analyze regulatory trends, changes in legislation, and industry best practices to provide insights and recommendations.
• Reporting: Prepare regular reports on regulatory compliance status, upcoming regulatory milestones, and any issues requiring attention.

• Post-Market Surveillance: Oversee regulatory aspects related to the post-market lifecycle of drugs, including monitoring adverse events and ensuring compliance with post-market requirements.
• Labelling and Advertising: Ensure drug labeling and advertising materials comply with regulatory standards and guidelines.

• Issue Resolution: Manage regulatory crises or issues, including non-compliance notices or product recalls, to minimize the impact on the organization and ensure prompt resolution.

• Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or a related field.
• An advanced degree or certification in Regulatory Affairs is a plus.

• Minimum of 4 years of experience in regulatory affairs, preferably within the [industry-specific, e.g., pharmaceutical, medical devices, cosmetics] industry.
• Experience with regulatory submissions in major markets (e.g., FDA, EMA, TGA, etc.).