Key Responsibilities: Corporate Governance & Compliance: Advise the company on corporate governance matters and ensure compliance with Indian corporate laws, including the Companies Act, 2013, and related regulations. Assist in the drafting and review of board meeting minutes, resolutions, and other corporate governance documentation. Ensure the company adheres to regulatory requirements, including those imposed by the Securities and Exchange Board of India (SEBI), Reserve Bank of India (RBI), and other relevant authorities. Commercial Contracts: Draft, review, and negotiate various commercial contracts, including supply agreements, service agreements, distribution agreements, and confidentiality agreements. Ensure that contracts comply with Indian contract law and protect the company's interests Intellectual Property (IP): Advise on matters related to intellectual property, including trademarks, patents, copyrights, and licensing agreements. Manage the company's IP portfolio and ensure protection of the company's intellectual property assets. Litigation and Dispute Resolution: Represent the company in legal disputes, either directly or through external counsel. Provide legal support in resolving commercial disputes, both litigation and arbitration. Regulatory and Legal Advice: Offer strategic legal advice on a wide range of issues, including tax law, labor and employment law, foreign exchange laws, and other regulatory matters. Work with government authorities, regulatory agencies, and external legal advisors to ensure compliance with all applicable laws and regulations. Risk Management: Identify and evaluate legal risks associated with business transactions and corporate activities. Advise senior management on strategies to mitigate legal risks and safeguard the company's interests. Corporate Restructuring and Financing: Provide legal counsel on corporate restructuring, capital raising, debt financing, and other corporate finance-related activities. Draft and negotiate loan agreements, shareholder agreements, and other related documentation.
Company Summary: Alpine Lifecare LLP is a medical plastics manufacturing facility based in Changodar, Ahmedabad where the company manufactures pharmaceutical vials, bottles ovals and other plastic items for pharmaceutical and medical device industry. Position Overview: As a Quality Control Executive in a plastic manufacturing unit, your primary responsibility will be to ensure that the products meet the required quality standards and specifications. You will play a crucial role in maintaining the reputation of the company by ensuring that the plastic products produced are of high quality, safe, and compliant with market expectation. You will work closely with production teams, engineers, and management to implement quality control processes and continuously improve the manufacturing process. Key Responsibilities: Quality Assurance: Develop and implement quality control procedures and guidelines for the entire plastic manufacturing process Monitor and assess the quality of raw materials, production processes, and finished plastic products to ensure they meet the defined standards Inspection and Testing: Conduct regular inspections and testing of plastic products using various tools, equipment, and testing methods to identify defects, deviations, and non-conformities Document and report inspection and testing results accurately for further analysis and improvement Conduct daily check of each process and activity being conducted as per the defined SOP Collect samples each day of ongoing production and test them for conformance at each stage Process Improvement: Collaborate with production and engineering teams to identify areas for process improvement, efficiency enhancement, and quality optimization Propose and implement corrective actions and preventive measures to address quality issues and minimize defects Documentation: Maintain records of quality control activities, test results, and inspection reports Generate reports and presentations to communicate quality performance and improvement initiatives to management Training and Education: Provide training to production staff on quality control procedures, standards, and best practices Ensure that all team members are knowledgeable about quality requirements and understand their role in maintaining product quality Problem Solving: Investigate customer complaints, returns, and issues related to product quality and work on root cause analysis to prevent recurrence Collaborate with cross-functional teams to address quality-related challenges and implement effective solutions Proactively suggest and implement quality enhancement initiatives to enhance product reliability and customer satisfaction
Company Description Alpine Health is a licensed pharmaceutical distributor based in Secaucus, New Jersey, USA. We serve independent pharmacies across the US. Alpine Health offers a full range of generics,OTC's, diabetic supplies, vials and nutritional milk.The organization is in business in the USA market since 2008 and is now expanding its reach of partnering with companies worldwide to introduce high quality medical devices in markets worldwide. Job Description Overview: This is an opportunity to work in a key role with a broad spectrum of responsibilities in a growing healthcare company that has expanded in various domains in the industry and to contribute to the growth of the company. The vision is to build strong medical device portfolio in the regulated markets across the world, where the regulatory function plays a crucial role in this development. The Regulatory Affairs Specialist reports to the site head in India. The work is with domestic and international focus and performed in close cooperation with several international development partners and manufacturers . Roles & Responsibilities: ? The individual will be working on regulatory requirement of Medical devices and Distribution in various markets ? Coordinate successful submissions and approval of all medical device approval applications with various regulatory authorities worldwide ? Keep up-to-date with changes in regulatory legislation and guidelines for medical devices across various markets ? Write comprehensible, user-friendly, clear product information leaflets and labels ? Review and report overall quality status to the management team ? Use a variety of specialist computer applications ? Explain regulations, policies, or procedures for medical device fillings ? Maintain data in information systems or databases ? Evaluate applicable laws and regulations to determine impact on company activities ? Provide technical review of data or reports ? Advice the operations and business team on applicable regulatory requirements, project specific regulatory issues as assigned. ? Act as back-up for contact with Regulatory Agencies as needed. ? Draft cover letters for Regulatory Agency communication. Regulatory Affairs Specialist Medical Devices ___________________________________________________ ? Assist with timely availability of submission documents and ensure that all document components are in place on time. ? Draft and review some document content (depending on level of regulatory knowledge/expertise). ? Understand submission details and liaise with Submission Management. ? Review of submission documents to ensure compliance with regulatory requirements. Desired Skills/Experience: ? Thorough understanding and demonstrated ability to apply regulatory guidelines/regulations to successful dossier preparation, submission and maintenance Strong initiation and organizational skills Basic analytical skill and technical/ scientific competence ? Attention to details and ability to appropriately assess risks and formulate risk- management strategies ? Proactive, quick learner and independent worker able to effectively multi-task in a high- pressure environment and follow issues through to conclusion Requirements: ? An advanced degree (MS) is highly preferred; a minimum of a Bachelor's Degree in Bio- medical engineering is required. ? 5+ year relevant experience in regulatory affairs and product registrations across various markets. ? Understanding of the regulatory submission and approval process of medical devices is required. ? Candidate must be able to work successfully within a team environment and as an individual contributor.
The Regional Sales Manager (RSM) GI Division is responsible for driving sales performance and market share growth for gastrointestinal (GI) therapy products across a defined region. This role involves leading a team of Area Sales Managers (ASMs) and Medical Representatives (MRs), ensuring high-quality ethical promotion to healthcare professionals, and executing strategic marketing initiatives. The RSM acts as a key contributor to expanding the reach and reputation of the company's GI portfolio within the region Key Responsibilities: Lead and manage the regional sales team to achieve assigned sales targets for the GI therapy portfolio. Ensure ethical promotion of GI products in line with company values and industry regulations. Develop and implement region-specific sales strategies to penetrate the GI therapy market. Regularly conduct joint fieldwork, review performance, and provide on-the-job coaching to Area Sales Managers and Medical Representatives. Establish and nurture relationships with gastroenterologists, general practitioners, and key opinion leaders (KOLs) in the GI space. Monitor regional market trends, competitor activities, and emerging needs in GI therapeutics. Drive execution of marketing programs, CMEs, doctor engagement activities, and patient education initiatives related to GI health. Collaborate with marketing, medical affairs, and training teams to ensure scientific accuracy and promotional effectiveness. Ensure distributor coordination, inventory optimization, and timely collection in the region. Maintain accurate documentation, reporting, and compliance with internal SOPs and industry regulations. Desired Profile: Strong background in gastrointestinal therapy sales, with a proven track record of performance in ethical marketing. In-depth knowledge of GI conditions, treatment approaches, and the regional Healthcare Practitioner ecosystem. Experience in launching or scaling GI brands (e.g., antacids, PPIs, enzymes, probiotics, hepatoprotectives, laxatives). Excellent leadership, communication, and team development skills. Analytical thinking with ability to convert market insights into strategic actions. Highly ethical, self-motivated, and goal-driven. Comfortable with extensive travel across the region.