Regulatory Affairs Specialist
2 months ago
Job Location: Andheri West
Company profile:
Established in 1975, Ashish Life Science Pvt. Ltd. is a member of the "Ashish Group of Industries." We commenced our pharmaceutical manufacturing operations in 2002. Since our inception, we have been dedicated to serving customers worldwide by providing veterinary products, regardless of the order size. Over the years, we have earned a reputation for reliability and trustworthiness with our clients. Our commitment to personalized service, strong working relationships, and customer satisfaction extends globally.
Our team comprises dedicated professionals who value learning, empathy, and innovation. We demonstrate high diligence in every aspect of our operations. Our adherence to quality, implementation of best-in-class manufacturing practices, investment in infrastructure, highest laboratory certifications, and exceptional service standards have allowed us to establish enduring relationships worldwide.
We are a frontrunner in veterinary pharmaceuticals, serving over 65 countries worldwide. We've earned the distinction of being India's largest exporter of veterinary drugs, ensuring animal health solutions reach a global audience.
Our dedication to customer service extends beyond borders. We have a dedicated team in Africa, along with a network of 7 regional offices around the world, allowing us to provide direct support to our customers.
With a team exceeding 30 veterinarians worldwide, we possess the expertise to deliver on our core mission: improving animal health and wellbeing through innovative solutions. We empower farmers to provide better care for their animals.
For more information
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Job Overview:
The Assistant Manager of Regulatory Affairs is responsible for supporting the regulatory compliance and submission activities within the pharmaceutical company's formulation manufacturing division. This role involves ensuring that products meet all regulatory requirements for approval and market entry, maintaining documentation, and coordinating with various departments to ensure timely submissions. The Assistant Manager will also be involved in monitoring regulatory changes, preparing dossiers, and communicating with regulatory bodies.
Key Responsibilities:
1. Regulatory Submissions:
o Prepare, compile, and review regulatory submissions, including ANDAs (Abbreviated New Drug Applications), NDAs (New Drug Applications), CTDs (Common Technical Documents), and other dossiers required for product approval.
o Ensure timely submission of dossiers to regulatory authorities (e.g., FDA, EMA, MHRA, etc.).
o Coordinate with R&D, Quality Assurance, and Manufacturing teams to gather necessary documentation for submissions.
2. Regulatory Compliance:
o Ensure that all products comply with the regulatory requirements of the target markets.
o Review and approve product labeling, packaging, and promotional materials for compliance with regulatory standards.
o Maintain up-to-date knowledge of current and changing regulations in key markets.
3. Documentation and Record Keeping:
o Maintain accurate and comprehensive regulatory documentation, including product master files, technical files, and registration certificates.
o Update and manage regulatory databases to track submission statuses, approvals, and regulatory commitments.
4. Regulatory Strategy:
o Assist in developing regulatory strategies to support the timely approval and market launch of products.
o Provide input on regulatory pathways for new products and lifecycle management of existing products.
o Identify potential regulatory risks and provide mitigation strategies.
5. Communication and Liaison:
o Serve as a point of contact between the company and regulatory agencies.
o Respond to queries and requests from regulatory bodies in a timely and accurate manner.
o Liaise with external consultants, contractors, and service providers to support regulatory activities.
6. Cross-functional Collaboration:
o Work closely with internal departments such as R&D, Quality Control, Quality Assurance, and Manufacturing to ensure regulatory compliance across all stages of product development and production.
o Participate in cross-functional teams to support product launches and other regulatory initiatives.
7. Training and Development:
o Provide training and guidance to junior regulatory staff and other departments on regulatory requirements and best practices.
o Stay updated with the latest regulatory trends and guidelines and share insights with the team.
8. Regulatory Intelligence:
o Monitor and analyze changes in global regulatory environments that could impact the company’s product portfolio.
o Assess the impact of new regulations on ongoing and future projects and advise the management accordingly..
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