You will be responsible for extending the global reach of the company through expert discovery and exploration of new and untapped business opportunities and relationships. As an International Business Developer, your primary role will involve finding and retaining clients, encouraging existing clients to purchase additional products or features, and staying informed about changes in consumption trends. Your key responsibilities will include performing business development activities in the pharma or Medical Device domain, demonstrating the ability to source leads from the international marketplace, generating leads, converting them into projects, and possessing experience in international business development. Fluency in German or French is preferred for this role. To qualify for this position, you should have a degree in BVSC, BHM, BHMS, B.Pharma, BAMS, or any other specialization at the graduate level. Additionally, a postgraduate degree such as MS/M.Sc in Biotechnology, Agriculture, Bio-Chemistry, Biology, Botany, Chemical Engineering & Materials Science, Chemistry, M.Pharma, or M.Tech in Environmental, Instrumentation, Bio-Chemistry, Bio-Technology, Biomedical, or Chemical is preferred. The ideal candidate should be familiar with the Pharma international market, Research & Development, and Regulatory Processes. Prior experience in Regulatory affairs or licensing Pharmaceutical products or medical devices is a plus. Strong negotiation skills are essential for this role.,
As an experienced medical writer with expertise in CTD medical writing and clinical development of medicines, your responsibilities will include the following: Writing high-quality CTD modules such as nonclinical and clinical overviews & summaries (Module 2.5, 2.4, 2.7, 2.7) to meet EU submission requirements. Addressing clinical deficiencies by providing appropriate responses. Contributing to drug development strategy. Updating documents like SmPC, Patient Information Leaflet, CCDS, Safety variations. Preparing Clinical Study Reports, Study design, and synopsis. Assisting in the formulation of clinical development strategies and reviewing study reports and published papers. Conducting literature searches and regulatory evaluations. Evaluating Rx to OTC transitions. Handling tasks such as PSURs, PADER, and RMP. To be considered for this role, you should have the following qualifications and skills: MBBS in Medicine/ M.Pharma in Pharmacy/ Medical-MS/MD in Pharmacology/ Ph.D/Doctorate in Pharmacy. Prior experience in medical writing for regulatory submissions in Europe. Expertise in areas like non-clinical overview, clinical overview, PSUR, EU submission, Clinical Pharmacology, module 2.5, Scientific Writing ICH, Regulatory Submissions, Medicine, DCP, CTD, Clinical Research, medical writer, Medical Writing, and EMA labelling Module 2.4. Demonstrated scientific accuracy and attention to detail. Understanding of Generic, Hybrid, and New drug applications. Proficiency in Clinical study design and protocol development. Excellent communication abilities and efficient time management. Specialization in Pharmacology would be advantageous for this role.,
You will be working at Silmed Scientific, an organization dedicated to public health safety through scientific evaluation and assessment of healthcare products. The company aims to ensure the global availability of safe products and fosters a unique working culture. As a Regulatory Medical Writer at Silmed Scientific, your primary responsibilities will include: - Authoring and reviewing Regulatory submission documents for pharmaceutical marketing authorization in Europe and the United States. - Developing Common Technical Document (CTD) modules like nonclinical and clinical overviews & summaries (Module 2.4, 2.5, 2.6, and 2.7), expert reports, safety & efficacy summaries, as well as Aggregate safety reports (e.g., PSURs, PADER), product monographs, SmPCs, patient information leaflets, and regulatory strategy reports. - Providing advice on clinical/nonclinical development questions and preparing biowaiver reports. - Conducting literature searches to support the regulatory writing process. To qualify for this role, you must meet the following requirements: - Hold an MPharm or Ph.D. in Pharmacology, or an MBBS or MD in Pharmacology. - Have 2-8 years of experience in Medical writing. - Possess excellent communication and writing skills. - Demonstrate prior experience in Regulatory Medical writing for EU Submissions with reputable pharmaceutical companies. - Show a proven track record in writing CTD modules 2.4 and 2.5 for generic and bibliographic applications. - Ability to present research data in a reader-friendly manner to the target audience. - Have in-depth knowledge of various therapeutic areas. - Familiarity with relevant guidelines for the structure and contents of specific documents, along with a good understanding of the Vancouver style of referencing. - Proficiency in searching medical literature databases like PubMed, EMBASE, among others.,
As an International Business Developer at our company, your main role will be to extend our global reach by expertly discovering and exploring new and untapped business opportunities and relationships. You will be responsible for finding and retaining clients, encouraging existing clients to purchase additional products or features, and staying updated on changes in consumption trends. Key Responsibilities: - Perform business development activities in the pharma or Medical Device domain - Ability to bring leads from the international marketplace - Generate leads and convert them into projects - Experience in international business development - Fluency in German or French is preferred Qualifications Required: - BVSC - Any Specialization/ BHM - Any Specialization/ BHMS - Any Specialization/ B.Pharma - Pharmacy/ BAMS - Any Specialization/ Other Graduate - Other Specialization - MS/M.Sc(Science) - Biotechnology/ Agriculture/ Bio-Chemistry/ Biology/ Botany/ Chemical Engineering & Materials Science/ Chemistry/ M.Pharma - Any Specialization/ M.Tech - Environmental/ Instrumentation/ Bio-Chemistry/Bio-Technology/ Biomedical/ Chemical - Familiarity with Pharma international market, R&D, and Regulatory Processes - Prior experience in Regulatory affairs or licensing Pharmaceutical products or medical devices - Excellent negotiation skills This role offers the opportunity to contribute significantly to our global growth and success through your expertise in international business development and client management.,
As a Regulatory Affairs Manager, you will play a crucial role in monitoring the company's production activities to ensure compliance with all applicable regulations and standard operating procedures. Your responsibilities will include devising regulation compliance strategies, creating training and orientation programs for staff, conducting internal inspections and information drives, and staying updated with the latest rules and regulations. Key Responsibilities: - Possess in-depth technical knowledge of Chemistry, Manufacturing, and Controls (CMC) aspects, dossier compilation, review, evaluation, and compilation for new marketing authorizations. - Review and approve submission documents according to regulatory guidelines, evaluate changes in CMC documentation impacting regulatory submissions, strategize filing categories, and compile submissions for Europe, FDA, and other international markets. - Conduct Due Diligence and develop CMC strategy for complex injectable products, with a strong background in CMC requirements for EU/US solid dosage forms and/or complex injectables, particularly in Ophthalmic products. - Collaborate with internal and external stakeholders to compile high-quality regulatory submissions within specified timelines, ensuring accuracy, compliance, and quality of submission documents. - Evaluate change controls independently in alignment with regulatory requirements, strategize filing categories, compile submissions, and resolve complex issues for EU and international markets. - Demonstrate strong interpersonal skills for effective verbal and written communication in a collaborative work environment. Extensive experience with ANDA/EU DCP/ IMPD/IND writing is expected. Qualifications Required: - MPharm/PhD/MSc in Chemistry or Biotechnology - 4-8 years of prior experience in regulatory affairs Please note that the given Job Description did not include any additional details about the company.,