7 Pharmaceutical Regulations Jobs

As an International Sales professional at GenAide Pharmaceutical Private Limited, a global pharmaceutical company based in Ahmedabad, your primary responsibility will be to grow and manage overseas client relationships while expanding the company's market presence. Your role will involve utilizing your expertise in pharmaceutical sales to drive sales in international markets strategically. You will be required to demonstrate a deep understanding of finished formulations and their market applications, as well as proficiency in export documentation and compliance with international trade regulations. Your negotiation skills will be crucial in closing deals and building long-term relationships with clients and partners. Additionally, your experience in B2B sales within the pharmaceutical industry and knowledge of pharmaceutical regulations will be valuable assets in ensuring compliance and facilitating smooth trade. Your key responsibilities will include identifying and exploring new business opportunities in international markets, developing strong client relationships, preparing and executing export strategies aligned with company goals, conducting market research, and negotiating terms and contracts with international clients. You will also be expected to ensure compliance with international trade laws and regulations, contribute to achieving team targets, and collaborate with cross-functional teams to streamline the supply chain and ensure timely delivery of products. By leveraging your skills and experience in international sales, you will play a crucial role in driving the overall success of GenAide Pharmaceutical Private Limited.,

The role of Scientific Writer Content involves updating or creating scientifically and medically accurate content for commercial and medico-marketing assets such as newsletters, RTEs, civics, social media posts, websites, digital and print brochures, banners, etc. You will be responsible for ensuring that the content for existing or new assets for Novartis Brand or products reflects the most recent changes to Important Safety Information (ISI), Prescribing Information (PI), and other reference documents. It is essential that these updates are consistent with the stringent MLR guidelines and specifications (Medical-Legal-Regulatory). As a part of the "Creative" team under Centralized Asset Support Team (CAST), you will need to demonstrate strong collaboration with colleagues across all Novartis sites in India, the US, Ireland, and Mexico. Operating in a metricized environment, maintaining the highest quality standards, and embodying Novartis values and behaviors daily are also key aspects of this role. The key responsibilities of this position include developing and reviewing scientifically accurate, engaging, and compliant promotional materials like iCVAs, brochures, digital campaigns, emails, social media posts, banners, etc. You will ensure that the messaging is consistent with brand strategy and aligned with approved product positioning. Additionally, you will partner with cross-functional teams to plan and execute content strategy across different platforms, supporting omnichannel content planning and contributing to modular content models. Monitoring and interpreting label updates, ensuring timely content revision across all promotional assets, and liaising with editorial, creative, and regulatory teams to maintain alignment with the latest approved label are also crucial responsibilities. In terms of qualifications, an advanced degree in life sciences, pharmacy, medicine, or a related field is required, along with at least 7 years of experience in scientific writing focusing on promotional material, content planning, and label updates. A deep understanding of promotional scientific communications, clinical data interpretation, pharmaceutical regulations, and familiarity with promotional content review systems and relevant codes are necessary. Strong strategic thinking abilities, excellent communication skills, and the capacity to work cross-functionally in a matrix environment with high attention to detail and timelines are also essential. Exposure to global content localization/adaptation, understanding of omnichannel marketing, and familiarity with modular content are additional advantageous qualifications. Novartis is committed to fostering an outstanding, inclusive work environment with diverse teams that are representative of the patients and communities served. The company is also dedicated to working with individuals with disabilities and providing reasonable accommodations. If you require an accommodation due to a medical condition or disability during the recruitment process or to perform essential job functions, please contact diversityandincl.india@novartis.com. Novartis offers a collaborative community of smart, passionate individuals dedicated to making a positive impact in patients" lives through innovative science. If you are ready to contribute to creating a brighter future together, consider joining the Novartis team. To explore potential career opportunities at Novartis, you can sign up for the talent community to stay connected and informed about suitable roles as they become available. For more information about the benefits and rewards Novartis provides to help employees thrive personally and professionally, please refer to our handbook: https://www.novartis.com/careers/benefits-rewards.,

As a Medical Advisor at our company, you will be responsible for supporting medical and scientific initiatives related to our product portfolio. Working closely with internal teams including regulatory, marketing, and R&D, you will ensure that our products are supported by accurate clinical data and adhere to industry regulations. Your role will be crucial in generating medical insights, supporting product launches, providing medical information, and ensuring the safe and effective use of our products. You should hold a degree in MBBS, BDS, PharmD, or a related field, with a preference for a Masters Degree or relevant certifications in Medical Affairs. Ideally, you will have 2-3 years of experience in medical affairs, clinical research, or a similar role within the pharmaceutical industry. Exposure to scientific communications, clinical data interpretation, or medical support in product launches will be advantageous. Your responsibilities will include supporting the development and dissemination of clinical and scientific data to ensure product safety and effectiveness, providing medical expertise during product launches and marketing activities, and collaborating with internal teams to align medical and scientific information. Additionally, you will assist in preparing scientific reports, presentations, and medical education materials, ensuring compliance with regulations and internal policies, and participating in medical training sessions for internal teams. Key performance indicators for your role will include the accuracy and timeliness of clinical and medical data dissemination, contribution to product launches and alignment with marketing strategies, compliance with industry regulations and company policies, and participation in internal medical training programs. To succeed in this role, you should possess a strong understanding of clinical data and medical communications, excellent communication and presentation skills, the ability to collaborate with cross-functional teams, strong attention to detail and organizational skills, knowledge of pharmaceutical regulations and industry standards, and proficiency in medical writing and scientific documentation. Your operating network will include internal stakeholders such as the Head of Medical Affairs, Regulatory team, Marketing team, R&D, and Sales team, as well as external contacts in healthcare professionals and scientific communities.,

Job Description: You will be responsible for dispensing prescription medications and ensuring the accuracy of drug orders and information as a full-time on-site Pharmacist at Self-employed in Amravati. In addition, you will provide excellent customer service to meet the needs of patients effectively. Your role will require a valid Pharmacist license, strong attention to detail, and accuracy in your work. Excellent communication and interpersonal skills are essential for successful interaction with patients and colleagues. Collaborating effectively within a team environment and adhering to pharmaceutical regulations and guidelines will be key aspects of your responsibilities.,

You should have 2-3 years of experience in pharmaceutical sales, specifically in selling Gynecology & Orthopedic drugs. Your educational background should include a B.Pharma or M.Pharma degree. Your main responsibilities will include promoting and selling gynecology and orthopedic pharmaceutical products to doctors, hospitals, and pharmacies. It will also involve building and maintaining strong relationships with gynecologists, orthopedic specialists, and other healthcare professionals. You will need to conduct product presentations, demonstrations, and training sessions, as well as develop and execute effective sales strategies to meet and exceed targets. Monitoring market trends, competitor activities, and customer needs to identify growth opportunities is crucial. Furthermore, ensuring timely reporting of sales activities, customer feedback, and market insights is essential. Key skills and requirements for this role include proven experience in selling gynecology and orthopedic drugs, strong communication, persuasion, and negotiation skills, and a deep understanding of pharmaceutical regulations and compliance. You should be willing to travel for field visits and client meetings, and possess a self-motivated and result-driven approach. Your skills should encompass pharmaceutical sales, gynecology drugs, orthopedic drugs, market analysis, team collaboration, distribution, time management, adaptability, persuasion skills, negotiation skills, hospitals, compliance, healthcare, communication skills, pharmaceutical regulations, and sales.,

Business- Pharma Formulation( P2P)/Contract Manufacturing/ 3rd Party Manufacturing Division: Oncology ( Injectables/Solid Orals) Location- Vadodara (Corporate Office) Designation: Sr. Executive/ AM/Manager Job Description : Responsibilities: 1. Market Research and Analysis: Conduct thorough market research to identify potential clients, market trends, and competitors. Analyse market data to develop strategies for expanding the company's presence in the domestic pharmaceutical formulation sector. 2. Business Development: Identify and pursue new business opportunities in the domestic market, particularly focusing on (P2P) transactions. Develop and maintain relationships with pharmaceutical companies, distributors, and other stakeholders. Collaborate with the sales team to create effective sales strategies and achieve sales targets. Negotiate contracts and agreements with clients to ensure mutually beneficial partnerships. 3. Client Relationship Management: Build and maintain strong relationships with existing clients to ensure customer satisfaction and retention. Address client inquiries and concerns promptly, providing excellent customer service. Gather feedback from clients and use it to improve products and services. 4. Collaboration and Coordination: Work closely with internal teams such as production, quality assurance, and regulatory affairs to ensure seamless execution of client projects. Collaborate with cross-functional teams to develop innovative solutions and enhance the company's offerings. 5. Reporting and Analysis: Prepare regular reports on sales activities, client interactions, and market trends. Analyze sales data to identify areas for improvement and implement necessary changes. Qualifications: Bachelor's degree in Business, Marketing, or a related field. Master's degree is a plus. Minimum of 8-12 years of experience in business development and sales within the pharmaceutical industry, specifically in Pharma Formulation for the domestic market. Proven track record of achieving and exceeding sales targets. Excellent communication and negotiation skills. Strong analytical and problem-solving abilities. Familiarity with P2P business transactions and digital platforms is highly desirable. Knowledge of pharmaceutical regulations and market dynamics in the domestic sector. Ability to work independently and as part of a team, demonstrating leadership qualities.

We are looking for a meticulous Executive/Sr. Executive to spearhead regulatory submissions and review at Synnat Pharma Private Limited. In this pivotal role, you will be instrumental in ensuring our API manufacturing processes adhere to global pharmaceutical regulations. Your expertise will be essential in compiling, reviewing, and submitting comprehensive regulatory documentation to various health authorities, including the US FDA, EMA, and CDSCO. You will manage regulatory inspections, handle queries, and lead the preparation of DMF filings. The ideal candidate will possess a deep understanding of regulatory guidelines, ICH guidelines, and relevant pharmacopeias (USP, EP, BP), coupled with experience in process validation and variation submissions. Your responsibilities will extend to maintaining robust electronic document management systems (EDMS) and ensuring manufacturing records align with regulatory requirements. This position demands a proactive individual with excellent communication skills to effectively liaise with regulatory agencies and internal stakeholders, ensuring Synnat Pharma maintains its commitment to quality and compliance in the pharmaceutical industry. Job Details: Industry: Pharmaceutical (API Division) Department: Regulatory Affairs Role: Executive/Sr. Executive Location: Visakhapatnam Compensation: 5,00,000 - 10,00,000 INR per annum Experience: 5-9 years Qualification: Bachelor's degree in Pharmacy, Chemistry, or related field Responsibilities: R egulatory Submissions & Documentation: Prepare, review, and submit comprehensive regulatory dossiers and technical documentation for API products to various health authorities (US FDA, EMA, CDSCO). Manage the compilation, archiving, and tracking of all regulatory documentation using electronic document management systems (EDMS). Ensure all regulatory submissions are accurate, complete, and compliant with current regulatory guidelines and requirements. Maintain up-to-date knowledge of changes in pharmaceutical regulations and guidelines and communicate these changes to relevant stakeholders. Prepare and manage Drug Master File (DMF) filings, renewals, and updates, ensuring timely submissions and compliance. Coordinate with cross-functional teams (manufacturing, quality control, R&D) to gather necessary data and documentation. Regulatory Compliance & Inspections: Lead and manage regulatory inspections conducted by health authorities, ensuring preparedness and compliance. Develop and implement corrective and preventive actions (CAPA) in response to inspection findings and regulatory queries. Conduct internal audits to ensure compliance with pharmaceutical regulations and quality standards related to API manufacturing. Review manufacturing records and analytical data to ensure compliance with regulatory requirements and guidelines. Monitor and ensure adherence to pharmacopeias (USP, EP, BP) and ICH guidelines in API manufacturing processes. Maintain a thorough understanding of API manufacturing regulatory compliance. Regulatory Communication & Liaison: Act as the primary point of contact for communication with regulatory agencies regarding submissions, queries, and inspections. Prepare and manage responses to regulatory queries and deficiency letters, ensuring timely and accurate information. Liaise with internal stakeholders to address regulatory issues and provide guidance on compliance matters. Communicate regulatory updates and changes to relevant departments. Cultivate and maintain positive relationships with regulatory agencies. Provide support and guidance to cross-functional teams on regulatory expectations. Variation & Renewal Management Prepare and submit variation applications for changes to approved API manufacturing processes and formulations. Manage the renewal process for existing regulatory approvals, ensuring timely submissions and compliance. Assess the impact of proposed changes on regulatory filings and ensure appropriate documentation is prepared. Track the status of variation and renewal applications and communicate updates to stakeholders. Ensure all variations and renewals align with current regulatory guidelines. Maintain a comprehensive record of all variations and renewals submitted General Expectations and Past Experiences: Possess a Bachelor's degree in Pharmacy, Chemistry, or a related scientific field. Demonstrated experience (6-9 years) in regulatory affairs within the pharmaceutical industry, specifically in API manufacturing. Proven expertise in preparing and managing DMF filings and regulatory submissions for global health authorities (US FDA, EMA, CDSCO). Strong knowledge of pharmaceutical regulations, ICH guidelines, and pharmacopeias (USP, EP, BP). Experienced in regulatory inspections and responding to regulatory queries and deficiency letters. Proficient in EDMS and other relevant documentation systems. Excellent communication, interpersonal, and problem-solving skills with the ability to work cross-functionally.