8 Regulatory Services Jobs

As the AVP - Business Development at Remidio, you will play a crucial role in spearheading the company's expansion in the USA and Europe markets for medical device manufacturing and regulatory services. Your primary responsibilities will include identifying new opportunities, strengthening key relationships, driving revenue growth, and enhancing brand visibility in global markets. Your key responsibilities will involve expanding the business and acquiring new clients in the USA and Europe, developing a strategic sales pipeline, managing key accounts and relationships, enhancing brand positioning and market presence by representing Remidio at industry conferences, and leading a high-performing business development team with a focus on talent development and market expansion strategies. To excel in this role, you should have a Bachelor's or Master's degree in Business, Biomedical Engineering, or a related field, along with at least 7 years of experience in business development, sales, or strategic partnerships within the medical device manufacturing or regulatory sector. You should possess strong industry knowledge, networking abilities, communication skills, and proficiency in CRM software and project management tools. Frequent travel to the USA and Europe for client meetings and industry events is expected, along with hybrid/flexible work arrangements. In return, Remidio offers a competitive salary, performance-based incentives, global exposure, professional development opportunities, and travel opportunities to engage directly with clients and key stakeholders. If you are a strategic thinker, growth-driven leader, and passionate about driving international business, we welcome you to join Remidio's mission to revolutionize medical device solutions worldwide.,

As a LifeScience Regulatory Services Associate at Accenture, you will be a part of the Life Sciences R&D vertical, offering services ranging from research laboratories, clinical trials support, regulatory services, to pharmacovigilance and patient services solutions. Your role will involve performing regulatory affairs LCM with Veeva skill set of submission in accordance with ICH guidelines and other Health Authorities. You will review and transform Source Documents, conduct Quality Control (Document QC) checks for all submission components, and collect, collate, and evaluate the scientific data gathered as part of R&D. Additionally, you will advise on legal and scientific restraints and requirements, ensuring the organization's products comply with current regulations. To excel in this role, you should possess skills in problem-solving, detail orientation, results orientation, strong analytical skills, and Life Sciences Automation Enablement. Your responsibilities will include solving routine problems, following general guidelines, and receiving detailed to moderate level of instruction on daily work tasks and new assignments. Your interactions will primarily be within your team and direct supervisor, and the decisions you make will impact your own work. You will be an individual contributor within a team, focusing on predetermined tasks. Please note that this role may require you to work in rotational shifts. To be eligible for this position, you should have a Master of Pharmacy degree and 1 to 3 years of relevant experience in regulatory services within the life sciences industry. Join Accenture, a global professional services company with expertise in digital, cloud, and security, and contribute to improving outcomes for the world's leading biopharma companies.,

You will be joining Milind Nyati & Co, Chartered Accountants (MNC), a firm with rich experience in Accounting, Auditing, Income tax, GST, Corporate Laws, Ind AS implementation, Finance, and Regulatory Services. Our mission is to deliver value-based services that maximize client worth and enhance business prospects and growth. This mission is ingrained in our team, which is well-equipped with knowledge, experience, and integrity. As an Article Assistant based in Karnal, your role will be full-time and on-site. Your responsibilities will include assisting with bank audits, taxation, bookkeeping, internal audits, and other day-to-day tasks. Collaboration with team members will be essential to ensure the timely and accurate completion of assignments.,

As a LifeScience Regulatory Services Analyst at Accenture, you will be responsible for performing regulatory affairs tasks related to submission, review, transformation of Source Documents, and ensuring compliance with ICH guidelines and Health Authorities" regulations. Your role will involve handling the regulatory process for leading biopharma companies, advising on legal and scientific requirements, and building regulatory submission strategies. Your responsibilities will also include authoring CMC documents, health authority packages, and collecting, collating, and evaluating scientific data as part of R&D. To excel in this role, you should possess the following skills: - Ability to handle disputes - Ability to manage multiple stakeholders - Ability to meet deadlines - Ability to perform under pressure - Ability to work well in a team - Life Sciences Automation Enablement In this position, you will analyze and solve lower-complexity problems, collaborate with peers within Accenture, receive moderate-level instruction on daily tasks, and detailed instructions on new assignments. Your decisions will impact your own work and potentially the work of others. You will work as an individual contributor within a team with a focused scope of work. Please note that this role may require you to work in rotational shifts. If you have a Master of Pharmacy qualification and 3 to 5 years of experience in regulatory services within the life sciences industry, this role could be a great fit for you. Join us at Accenture, a global professional services company with expertise in digital, cloud, and security solutions, and be part of a team that delivers technology-driven solutions to clients in over 120 countries. Visit www.accenture.com to learn more about our organization and the opportunities we offer.,

The employer is a tax consulting and regulatory service provider, based out of Parel, Mumbai. The company offers services such as Tax and Regulatory Services, Litigation Assistance, M&A and transaction services, Fund raising & IPO assistance, and Succession Planning. As a Tax and Regulatory Associate, your responsibilities will include undertaking research in tax and regulatory areas, drafting necessary notes and opinions, assisting in creating deliverables in excel, PPT, or word format, drafting emails and other communication, helping with tax compliances including tax return filing, drafting firm materials, thought leadership articles, and maintaining client databases. You will also be responsible for coordinating client calls and meetings, assisting in setting up domestic funds, and ensuring tax and regulatory compliances for domestic funds. The ideal candidate for this role is a Chartered Accountant with a tax background, possessing good command over the English language and communication skills. Candidates who are freshly qualified with experience in a large firm during articleship or Chartered Accountants with 1-2 years of experience are encouraged to apply. Exposure to areas such as income tax/corporate tax compliance, planning, and advisory, international tax structuring, FEMA, RBI, and SEBI regulations, double tax avoidance agreements, and preparing News Alerts, firm-level brochures, and writing articles for tax and regulatory updates will be considered an added advantage. If you meet the qualifications and are looking to participate in firm-level initiatives while contributing to the growth and success of the organization, we invite you to apply for this exciting opportunity.,

The objective of the advisory risk services at EY is to provide clients with a candid and reliable overview of their risk landscape, helping them to build confidence and trust with their customers, the market, and regulatory bodies. As a part of this team, you will be responsible for executing client-related engagements in various areas such as internal audits, risk assurance, risk transformation, and financial services risk management. Your key responsibilities will include effectively engaging with clients and executing engagements under the supervision of Seniors and Managers. You will work on client engagements related to Business Risk services like internal audit, enterprise risk management, compliance risk, regulatory services, internal controls, contract risk services, business process management, and other related solutions. Additionally, you will drive innovation in service delivery, assist with business development proposals, contribute to methodologies development, and participate in firm-wide initiatives. To excel in this role, you should continuously strive towards achieving goals, exceeding client and team expectations, conducting research, preparing client presentations, and contributing to advisory engagements. Your role will also involve project execution, reviewing work done by subordinates, and ensuring adherence to EY's code of conduct and quality standards. To qualify for this role, you must be a Chartered Accountant and exhibit initiative, flexibility, quick learning abilities, structured thought process, problem-solving skills, and industry focus. Ideally, you should also be willing to travel, work in diverse teams, possess good interpersonal and communication skills, and be IT savvy. EY is looking for passionate leaders with a strong vision and a desire to stay abreast of trends in the risk industry. If you are genuinely passionate about helping businesses reach their full potential, this role is for you. EY offers a culture of inclusivity and is open to flexible working arrangements to help you achieve a balance between personal and professional priorities. As a global leader in assurance, tax, transaction, and advisory services, EY is committed to providing training, opportunities, and creative freedom to its employees to make a positive impact. Joining EY means becoming a part of a culture that values excellence and ensures a lasting and rewarding experience throughout your career.,

As a Pharmacovigilance Services Associate at Accenture, you will play a crucial role in Pharmacovigilance Operations, focusing on Drug Safety Surveillance. You should hold a Bachelor of Pharmacy or Master of Pharmacy degree and have 1 to 3 years of relevant experience. Accenture is a global professional services company known for its expertise in digital, cloud, and security solutions. With a workforce of 699,000 individuals across 120 countries, we specialize in Strategy and Consulting, Technology, and Operations services. At Accenture, we leverage technology and human ingenuity to drive value and success for our clients, shareholders, partners, and communities. In this role, you will be part of the Life Sciences R&D vertical, supporting services that cover the entire life sciences landscape. From research laboratories to clinical trials support and regulatory services, your responsibilities will include pharmacovigilance and patient services solutions. You will collaborate with leading biopharma companies to bring their visions to life and enhance patient outcomes by integrating scientific expertise with insights into the patient experience. Your primary responsibilities will involve managing the Affiliate Mailbox, reconciling reports, and following up on Serious and Non-serious cases. You will be tasked with case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for Individual Case Safety Reports (ICSRs) in compliance with client guidelines and global regulatory requirements. As a Drug Safety Associate, you will be expected to solve routine problems using general guidelines and referrals, with interactions primarily within your team and direct supervisor. You will receive detailed instructions for daily tasks and new assignments, and your decisions will directly impact your work. Working as an individual contributor within a focused team, you may be required to work in rotational shifts. If you are passionate about pharmacovigilance operations, drug safety surveillance, and making a positive impact in the life sciences industry, this role at Accenture offers an exciting opportunity to contribute to cutting-edge solutions that improve patient outcomes and drive innovation.,

As a Clinical Data Services Associate at Accenture, you will play a crucial role in the Clinical Data Management team. Your responsibilities will include collecting, integrating, and ensuring the availability of data at the appropriate quality and cost. You will be involved in activities such as reviewing discrepancies, generating queries, and resolving them. Additionally, you will create CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. Your expertise will help in identifying and addressing protocol deviations in the database, performing edit check validation, writing test scripts, and conducting database validation (UAT) against specified CRF/ECRF. You will also manage clinical data management projects, ensuring the collection, integration, and availability of data at the required quality and cost to support the conduct, management, and analysis of studies in clinical research. To excel in this role, you should have the ability to establish strong client relationships, handle disputes effectively, manage multiple stakeholders, meet deadlines consistently, and work collaboratively in a team environment. Your role will involve solving routine problems based on established guidelines and seeking guidance from your team and supervisor when needed. You will receive detailed instructions on your daily tasks and new assignments, with the decisions you make impacting your own work within a focused scope. Please be aware that this position may require you to work in rotational shifts. With a Bachelor of Pharmacy or Master of Pharmacy qualification and 1 to 3 years of relevant experience, you will contribute to Accenture's global professional services company. Accenture is known for its expertise in digital, cloud, and security solutions, offering services across various industries to drive value and success for clients worldwide. Join Accenture's Life Sciences R&D vertical, where you will be part of a team dedicated to supporting the world's leading biopharma companies in bringing their vision to life. By converging around the patient and combining scientific expertise with unique insights into the patient experience, you will help improve outcomes and drive innovation in the healthcare sector. Discover a rewarding career at Accenture, where you can leverage your skills in Clinical Data Management to make a meaningful impact on the future of healthcare. Visit www.accenture.com to learn more about our company and explore the opportunities awaiting you in our dynamic and innovative organization.,