652 Clinical Trials Jobs - Page 17

As a Senior Clinical Trial Transparency Associate you will be joining the worlds largest & most comprehensive clinical research organisation, powered by healthcare intelligence, You will oversee and execute the clinical transparency (i-e, registration, updates and/or results disclosure) or public disclosure processes for assigned studies and/or assets conducted by client globally, What You Will Be Doing Manage the creation and maintenance of clinical transparency or public disclosure process documents while ensuring adherence to all applicable laws, regulations, industry guidance and corporate position, Monitor and interpret global regulatory requirements and the industry environment affecting clinical transparency or public disclosure and communicate changes to the fellow team members, partner departments and department stakeholders, Assess requirements for clinical trial registration / disclosure of results or public disclosure strategy plans, Make appropriate decisions regarding the applicability and timing of clinical transparency or public disclosure activities according to national laws, regulations, industry guidance and corporate position, Manage the review and approval process for clinical trial registrations, registration updates, results disclosures or public disclosure strategy plans or public disclosure tracking mechanisms, including communication with partner companies or collaborators, Facilitate periodic review of active registrations or public disclosure strategy plans to ensure records are updated or verified as required, Provides feedback to Clinical Transparency or Public Disclosure leadership resulting from new and updated transparency requirements You Are Bachelors Degree, or equivalent experience required, 5 years pharmaceutical industry experience required with experience in Transparency and/or Disclosure activities Working knowledge of clinical drug development and clinical trial protocols Excellent organizational skills and high attention to detail, Healthcare professional background preferred What ICON Can Offer You Our success depends on the quality of our people Thats why weve made it a priority to build a diverse culture that rewards high performance and nurtures talent, In addition to your competitive salary, ICON offers a range of additional benefits Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family, Our Benefits Examples Include Various annual leave entitlements A range of health insurance offerings to suit you and your familys needs Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your familys well-being Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON: https://careers iconplc,com/benefits https://careers iconplc , com / reasonable-accommodations Interested in the role, but unsure if you meet all of the requirementsWe would encourage you to apply regardless theres every chance youre exactly what were looking for here at ICON whether it is for this or other roles,

Select the apt sample size; collect data; perform the test; and develop TLG (tables, listings, and graphs); and finally, report the inference. Review of ADaM Specifications and TLGs. Develop statistical analysis plans (SAPs) in alignment with clinical protocols and regulatory guidelines (ICH, FDA, EMA). Perform and validate complex statistical analyses using SAS and R , ensuring accuracy and reproducibility. Provide statistical input into clinical study design, sample size calculation, randomization, and data collection strategies. Collaborate closely with Clinical, Data Management, Medical Writing, and Regulatory Affairs teams. Present and interpret statistical findings to non-technical stakeholders and contribute to publications or regulatory submissions (CSR, ISS/ISE, etc.). Lead or contribute to the development of standard operating procedures (SOPs), templates, and best practices. Mentor junior statisticians and provide peer review of statistical deliverables. Excellent written and verbal communication skills. Ability to manage multiple projects and priorities in a fast-paced environment. Location : Pan India Shift : General Shift

Diagnose and treat cancer patients, providing personalized treatment plans including chemotherapy, radiation, and immunotherapy Conduct research and stay updated on the latest advancements in oncology treatments Collaborate with a team of surgeons, radiologists, and pathologists to ensure comprehensive patient care Must have an MD/MS/M.Ch degree with extensive experience in medical oncology Experience in clinical trials and cancer research publications is a plus

Diagnose and treat cancer patients, providing personalized treatment plans including chemotherapy, radiation, and immunotherapy Conduct research and stay updated on the latest advancements in oncology treatments Collaborate with a team of surgeons, radiologists, and pathologists to ensure comprehensive patient care Must have an MD/MS/M.Ch degree with extensive experience in medical oncology Experience in clinical trials and cancer research publications is a plus

Diagnose and treat cancer patients, providing personalized treatment plans including chemotherapy, radiation, and immunotherapy Conduct research and stay updated on the latest advancements in oncology treatments Collaborate with a team of surgeons, radiologists, and pathologists to ensure comprehensive patient care Must have an MD/MS/M.Ch degree with extensive experience in medical oncology Experience in clinical trials and cancer research publications is a plus

Conduct research and clinical trials in oncology, focusing on innovative cancer treatment methodologies. Work on drug development, biomarker discovery, and personalized medicine approaches. Collaborate with global research institutions and publish findings in peer-reviewed journals. Must have experience in molecular biology, genomics, and immunotherapy. Strong analytical and problem-solving skills are essential for data-driven decision-making in oncology research.

Conduct research and clinical trials in oncology, focusing on innovative cancer treatment methodologies. Work on drug development, biomarker discovery, and personalized medicine approaches. Collaborate with global research institutions and publish findings in peer-reviewed journals. Must have experience in molecular biology, genomics, and immunotherapy. Strong analytical and problem-solving skills are essential for data-driven decision-making in oncology research.

Conduct research and clinical trials in oncology, focusing on innovative cancer treatment methodologies. Work on drug development, biomarker discovery, and personalized medicine approaches. Collaborate with global research institutions and publish findings in peer-reviewed journals. Must have experience in molecular biology, genomics, and immunotherapy. Strong analytical and problem-solving skills are essential for data-driven decision-making in oncology research.

We are seeking a dedicated and detail-oriented Executive in Pharmacovigilance to join our team in India. The ideal candidate will have experience in monitoring drug safety and ensuring compliance with regulatory requirements. Responsibilities Monitor and evaluate adverse drug reactions and safety data from various sources. Prepare and submit periodic safety reports to regulatory authorities. Collaborate with cross-functional teams to ensure compliance with pharmacovigilance regulations. Conduct signal detection and risk management activities. Maintain up-to-date knowledge of pharmacovigilance guidelines and best practices. Skills and Qualifications Bachelor's degree in Pharmacy, Life Sciences, or related field; Master's degree preferred. 3-8 years of experience in pharmacovigilance or drug safety. Strong knowledge of ICH/GCP guidelines and regulatory requirements. Proficiency in data analysis and interpretation of safety data. Excellent communication and interpersonal skills. Attention to detail and strong organizational skills.

Title Our global activities are growing rapidly, and we are currently seeking a full-time, office-based Medical Writer to join our Core Labs in Mumbai office. This position will work in a team to accomplish tasks and projects that are instrumental to the company’s success. Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities •Generate, revise, and maintain clinical documents; •Coordinate quality control of documents and maintain audit trail of reviews and changes; •Provide input on data analysis planning and its impact on clinical document outcome ; and •Performs other duties and responsibilities as assigned. Qualifications Master’s degree in a health or science-related field; Possess strong communication skills (oral and written); Intermediate knowledge of medical terminology and clinical patient management; People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps. EO/AA Employer M/F/Disability/Vets

Diagnose and treat cancer patients, providing personalized treatment plans including chemotherapy, radiation, and immunotherapy Conduct research and stay updated on the latest advancements in oncology treatments Collaborate with a team of surgeons, radiologists, and pathologists to ensure comprehensive patient care Must have an MD/MS/MCh degree with extensive experience in medical oncology Experience in clinical trials and cancer research publications is a plus

The Manager, CSAR - SAS Edit Check Programmer will report to the Sr. Manager, Clinical System and Analytical reporting and will be focused on supporting SAS Edit check programming activities. The Manager, CSAR - SAS Edit Check Programmer will create and implement edit checks, adhering to Amgen standards, procedures, and best practices using SAS programming. The position is expected to partner effectively with other CSAR Operations and cross functional staff to seamlessly ensure high quality deliverables, internal and external clinical systems, and other CSAR activities related to the use electronic data capture technology. The position will be responsible for quality and deliverables at the study and portfolio level. The Manager, CSAR - SAS Edit Check Programmer will also be expected to help deliver large system transformation projects, with a focus on project management, contribution of subject matter expertise, stakeholder engagement, and change management. The successful candidate will be a strong leader with demonstrated ability to influence stakeholders, while also acting as an individual contributor on study specific and general CSAR/Global Development Operations projects or operational work. Proven capability of providing support for study deliverables. Has operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC). Responsibilities include, but are not limited to, the following: Support of clinical trial platform technologies Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight. Coordinating and providing programming support to Clinical Study Teams Works collaboratively with Clinical Data Management to meet study deliverables and timelines Acting as a technical point of contact for systems deliverables on defined programs Experience in creating/programming complex SAS edit checks according to specifications, testing them for functionality and identify potential issues before implementation. Providing technical and business process input / expertise on new and emerging technologies Develop, review and implement policies, SOPs and associated documents Assist in preparing for and responding to audit findings (internal or external). Knowledge Good Clinical Practice Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking. Drug development and clinical trials processes Data management processes Programming of clinical trial databases and applications Proficient in SAS edit check programming Systems development lifecycle Programming Languages Project planning and management Collaborating with global cross-functional teams (team/matrix environment) Quality managementand Risk Analysis Regulatory filings and inspections Process improvement methodologies Preferred Qualifications Advanced degree or equivalent in life science, computer science, math, statistics, business administration or related disciplinewith 9-13 years of experience Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena Proven experience in managing teams General project management and planning experience Experience in oversight of outside vendors (CROs, central labs, imaging vendors, IRT vendors, etc.) Basic Qualifications Bachelors degree or equivalent in life science, computer science, business administration or related discipline with 9-13 years of experience Proven experience in managing teams Specialist knowledge / experience in life sciences or a medically related field General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company)

Providing insights on industry and market developments, including policy and regulatory updates to advocate for favourable outcomes. Analysis of Regulations, Guidelines, Policies, Important order, etc. to derive meaningful insights & actionable for higher management. Support in Policy Advocacy, legal & regulatory on filing petitions with appropriate authority. Support in review of bidding, bid documents, RFS & PPA. Support in creation of Memorandums of Understanding (MOU) with government bodies, ensuring alignment with legal and strategic frameworks. Supporting business development and project expansion, ensuring alignment with ENGIEs strategy and objectives. Building positive relationships with stakeholders, associations, etc. through appropriate management of expectations and objectives, ensuring consistent and effective communication. Will handle the Invoicing, NFA, payment disbursement activities, etc. Draft representations, communication for various stakeholders. Additional Responsibilities: Supporting corporate communications efforts with different stakeholders. Monitoring key industry events and, ensuring ENGIEs participation at appropriate levels to enhance visibility and influence.

Diagnose and treat cancer patients, providing personalized treatment plans including chemotherapy, radiation, and immunotherapy. Conduct research and stay updated on the latest advancements in oncology treatments. Collaborate with a team of surgeons, radiologists, and pathologists to ensure comprehensive patient care. Must have an MD/MS/M.Ch degree with extensive experience in medical oncology. Experience in clinical trials and cancer research publications is a plus.

Diagnose and treat cancer patients, providing personalized treatment plans including chemotherapy, radiation, and immunotherapy. Conduct research and stay updated on the latest advancements in oncology treatments. Collaborate with a team of surgeons, radiologists, and pathologists to ensure comprehensive patient care. Must have an MD/MS/M.Ch degree with extensive experience in medical oncology. Experience in clinical trials and cancer research publications is a plus.

Conduct research and clinical trials in oncology, focusing on innovative cancer treatment methodologies. Work on drug development, biomarker discovery, and personalized medicine approaches. Collaborate with global research institutions and publish findings in peer-reviewed journals. Must have experience in molecular biology, genomics, and immunotherapy. Strong analytical and problem-solving skills are essential for data-driven decision-making in oncology research.

Conduct research and clinical trials in oncology, focusing on innovative cancer treatment methodologies. Work on drug development, biomarker discovery, and personalized medicine approaches. Collaborate with global research institutions and publish findings in peer-reviewed journals. Must have experience in molecular biology, genomics, and immunotherapy. Strong analytical and problem-solving skills are essential for data-driven decision-making in oncology research.

Piramal Pharmasolutions is looking for Legal Trainee to join our dynamic team and embark on a rewarding career journey Conduct legal research on a variety of topics, including case law, statutes, regulations, and legal precedent, and provide summaries of findings to attorneys Draft and review legal documents, including contracts, briefs, memoranda, and pleadings Assist with legal proceedings, including discovery, depositions, and court appearances, as needed Maintain and organize legal files, including case files, contracts, and other legal documents Prepare and file legal documents with courts and other government agencies, as required Assist with due diligence efforts in connection with legal transactions and other business activities Communicate with internal and external stakeholders, including clients, opposing counsel, and government agencies, as needed

Lead scientific engagement with their Medical Experts. Implement clinical and educational strategies and respond to unsolicited medical enquiries. About the Role The MSL is responsible for scientifically engaging, collaborating and aligning with a broad range of external stakeholders to co-create value, address identified patient needs and ultimately change the practice of medicine for better patient access and outcomes. They leverage the right evidence at the right time during their scientific engagements, and identify impactful insights and opportunities that impact and inform the Integrated Product Strategy (IPS), Integrated Evidence Generation Plans, launch excellence roadmap, Patient Journey and medical strategies. MSLs also contribute to innovative healthcare partnerships and implement relevant disease area strategies. They will act as a strategic scientific partner, and collaborate with other Field matrix colleagues (e. g. Value/Market Access, HEOR, clinical research colleagues) to ensure Novartis can support healthcare systems strengthening & improve patient access and outcomes. Key Responsibilities Be a strategic internal partner, gather and leverage insights for an impactful contribution to Patient Journey mapping, launch excellence roadmap, integrated evidence generation plans, integrated product strategy and subsequently the medical strategy. Utilize knowledge of assigned therapeutic area and Novartis compounds to serve as the Medical, Clinical and Scientific expert to field matrix colleagues Identify data gaps, data generation opportunities (including RWE and implementation science, precision medicine), and key unmet needs and opportunities to help improve patient access and outcomes. Ensure appropriate identification and mapping of external stakeholders, aligned to the medical strategy, and in collaboration with other Novartis colleagues. Able to create personalized, flexible engagement strategies and plans, leveraging multiple channels and tailored content to meet the changing needs of external stakeholders Personalize and expand external stakeholder engagement beyond Healthcare Professionals. Support and contribute to innovative partnership models for shared ownership in transforming clinical practice, apply foundational impactful Scientific Engagement principles in stakeholder interactions in alignment with medical strategy and portfolio/pipeline prioritization. Communicate the right evidence to the right stakeholder at the right time, enabling stakeholders to make informed decisions, respond to unsolicited requests for information from stakeholders by sharing appropriate data regarding marketed and pipeline compounds in a timely, compliant, and stakeholder-focused manner. Support Novartis Clinical Trials, adopt and leverage digital channels for a broader, effective, personalized reach and impact, in addition to leading high level impactful scientific events, exchanges and medical education. Manage personal and professional development. , manage administrative responsibilities in a timely manner (customer relationship management tool, compliance training and other modules, expense reporting, etc. ). Promote and adhere to Ethics and Compliance Professional Practices Policy (P3). Wherever applicable, collaborate with medical teams & HCPs to facilitate MAPs (Managed Access Program) on receipt of unsolicited request. Essential Requirements: Pharmacist, Masters, or other post-graduate degree in health/life sciences. Doctoral degree preferred (PharmD, PhD, MD), Acts with credibility and clarity of purpose to build and maintain effective and collaborative relationships, working knowledge of the Healthcare System and research procedures as well as the guidelines relevant to the pharmaceutical industry. Experience in a medical function (2-3 years preferred) in at least one therapeutic area. Capable of self-directed learning and having a growth mindset, excellent communication, interpersonal, and influencing skills, with the ability to communicate effectively to a variety of audiences. Application of a curious mindset, employing active listening skills and asking open questions to gain insights and uncover current thinking. , capable to adapt, organize, prioritize, and work effectively and collaboratively on multifunctional teams in a dynamic field-based environment. Proven ability to successfully leverage new technology/digital/IT solutions for effective stakeholder mapping, development, management, and field medical insights gathering. Solid business mentality including innovative, solution-oriented, and critical thinking with performance-focused drive to achieve objectives and execute tactics, Strong personal integrity reflected in all actions and behaviors. Desirable Requirements: Oncology experience

Assist in the timely & professional ongoing Mgmt of data Operations on Use Cases/Demand deliverables and of clinical data warehouse maintenance with respect to cost, quality and timelines within Clinical Pipeline team Ensure high quality data available for secondary analysis use Support content development and upgrade to training modules into engaging and interactive applications Follows data regulations and laws, data-handling procedures and data mapping guidelines Supports quality deliverables within Clinical Data Operations (DO) Manage data Load, Transfer from Novartis Clinical Data Lake and conform of Clinical trial data to SDTM/ADaM compliant standards within the Clinical Data Warehouse Supports the delivery of quality data, processes and documentation contributor role in ensuring that use case/demands are executed efficiently with timely and high quality deliverables Major accountabilities: Demonstrates potential for technical proficiency, scientific creativity, collaboration with others and independent thought. Under supervision provides input into writing specifications for use cases/demand and necessary reports to ensure high quality and consistent data -Involved in User acceptance testing (UAT) and managing data mapping activities to maintain Clinical Data Warehouse -Under supervision, participates in ongoing review of all data generated from different sources -Supports the development of communications for initiatives. Perform hands on activities to conduct data quality assessments. Creates under supervision and learns relevant data dictionaries, ontologies and vocabularies -Reporting of technical complaints / special case scenarios related to Novartis data Collaborate with other data engineering teams to ensure consistent CDISC based data standards applied Be familiar with all clinical study documents from protocol to CSR including Data Management and Biostatistic documents. Key performance indicators: Achieve high level of quality, timeliness, cost efficiency and customer satisfaction across Clinical Data Operations activities & deliverables. No critical data findings due to Data Operations-Adherence to Novartis policy, data standards and guidelines -Customer / partner/ project feedback and satisfaction Work Experience: 3-5 years of experience in working in clinical trials data reporting Collaborating across boundaries. Knowledge of clinical data Availability of sufficient information to find and understand data Availability of data quality assessments Experience in Agile way of working would be a plus Skills: CDISC SDTM/ADaM Mapping Clinical Data Management. Experience in being able to work with different legacy, historical, local data standards SQL basic knowledges Python skills would be a plus Able to work in a worldwide team Data Privacy Data Operations. Data Science. Databases. Detail Oriented. Languages : English.

Avron Hospitals Pvt. Ltd. is looking for Clinical Pharmacist to join our dynamic team and embark on a rewarding career journey. Compounding and dispensing medications, as prescribed by physicians. Monitoring customers drug therapies, advising interventions, and informing customers of any potential side effects. Instructing customers on how and when to take prescribed medications. Conducting health and wellness screenings. Providing immunizations, and other medical services, such as taking blood pressure, temperature measurements, and checking blood sugar levels. Keeping accurate customer records. Ensuring a safe and clean working environment. Completing operational requirements of the pharmacy, including verifying order entries, maintaining records of controlled substances, charges, and removing expired and/or damaged drugs from the pharmacys inventory. Adhering to applicable legal rules, regulations, and procedures governing pharmaceutical practice. Performing other administrative tasks when needed.

Job Responsibilities Lead and manage a research team in order to curate accurate, timely, insightful and comprehensive data and intelligence; Identify and analyze the most relevant information for Beacon and its users; Coordinate with UK based clients on a regular basis to understand and meet the project deliverables. Manage the activities required towards launch of a beacon module and further support the needs towards maintenance post launch. You will be part of a global network of life science researchers working on dynamic, fast growing products in exciting, cutting edge life science areas. Perform data management activities on the assigned project in a timely and efficient manner Generate queries to clarify and improve the quality of the data Strong understanding of Clinical Trials and their data Strong understanding on preclinical data What attributes will you need? An ideal candidate might be a subject matter expertise in various drug therapies in field of oncology (Antibody drug conjugate/Bispecific/Adoptive cell therapy/Checkpoint modulators/oncolytic virus/Gene therapy) and experience with managing a team of resources Proven ability to deal with complex life science concepts Excellent written and verbal communication skills. Previous experience in a research role and/or data-oriented role is desirable but not essential. Experience and understanding in the field of pharmacology, drug discovery and development and clinical trials would be a bonus. Good project and people management skills are a must have. Results-oriented, passionate about delivering value and impact, proactive Most of all, you will need to be curious and willing to learn at all times. Eligibility: Masters in Pharmacy (except Pharmacognosy)/Biology/Bio-Technology/Bio-Chemistry/Pharm D with minimum 2-3+ years of relevant experience Bachelors in Pharmacy (except Pharmacognosy)/Biology/Bio-Technology/Bio-Chemistry with at-least 4 years of relevant experience Candidates with additional Clinical research diploma or relevant courses can apply. Candidate should have basic computer skills, Microsoft Office & detailed Internet Knowledge. Candidate should have one research paper published Ability to work in a high-pressure, deadline-driven environment Exceptional communication and reporting skills

About AstraZeneca AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world s most serious diseases. But we re more than one of the world s leading pharmaceutical companies. Regulatory Affairs Sr Manager (Clinical Trials ) Reports to Director - Regulatory Affairs Position purpose Coordinate with key stakeholders (local regulatory authority, local MC and Global Regulatory Affairs etc.) to achieve rapid/high-quality submissions and approvals related to Clinical Trials Prepare/review high-quality regulatory dossiers for GCT/Phase IV studies submissions Monitor the Clinical Trial approval process and promptly report whenever necessary Life cycle management of Clinical trials Adequate support in SEC preparations Collates, communicates, prepares/reviews to Health authorities queries Participate in Regulatory meetings with Health authorities as well as in internal meetings for Regulatory issues/follow-up. Performs periodic reviews of the archival Liaise with several government agencies to procure timely deliverables Minimum requirements Qualification : M.Pharm/B.Pharm/ 6-10 yrs Experience in India Regulatory function, knowledge of dossier compilation. He/ she should be conversant with Indian regulations. Key Result Areas/ outputs Adherence to AZ and industry codes of conduct, ethics and good regulatory practices Ensure that all licensing for assigned products is complete in accordance with relevant norms Develop and implement action regulatory plans for allocated products to achieve requisite approvals rapidly and facilitate rapid launch Maintain the awareness of, and shape the regulatory environment relevant to the assigned products portfolio Competitive Intelligence and analysis Adherence to AZ and industry codes of conduct, ethics and good regulatory practices Align with the values and vision of AZ Ensure compliance with Local legislation, Global regulatory policies, AZ code of conduct, Corporate Governance and Audit requirement Ensure that company confidentiality is maintained (i.e. intellectual property, product information and strategic information) Disclose potential breach of codes or conducts Key Result Areas/outputs Activities Ensure that all licensing for assigned products is complete in accordance with relevant norms Monitor status of product licenses Project manage changes in product licenses and coordinate with other changes, planned and in progress Maintain complete documentation records Communicate changes to licenses status promptly Develop and implement action regulatory plans for allocated products to achieve requisite approvals rapidly and facilitate rapid launch Maintain detailed knowledge of critical aspects of products: commercial strategies, content of the dossiers, regulatory intelligence, regulatory timelines and supply strategy Ensure that local regulatory strategies are consistent with global product strategies and local priorities Develop regulatory plan in conjunction with key stakeholders and ensure allocation of adequate resources and deliver plans on time Track status and take prompt corrective measures whenever necessary to ensure rapid approval and launch Provide Leadership and direction within project teams Strive to ensure high levels of performance and achievements. Take decision and accountability for actions. Build commitment within the team. Enhance positive attitudes and mindset. Demonstrate confidence and conviction. Challenge status quo for continuous improvement. Help build an open and trusting atmosphere. Assist in Issue Management Provide detailed information of regulatory status of affected products Undertake assigned follow-up action where necessary Maintain the awareness of, and shape the regulatory environment relevant to the assigned products Portfolio Interact with relevant regulatory authorities on a regular basis to facilitate the process of obtaining necessary approvals / permissions Monitor and understand the impact of external changes in the regulatory and political environment that will impact on the assigned products Communicate the impact of changes to key stakeholders. Influence key external stakeholders, in line with codes of conduct, to improve regulatory outcomes Develop excellent relationships and partnerships with Regulatory Authorities Competitive Intelligence and Analysis Monitor the global pipelines of competing pharmaceutical companies Analyse gathered information for its impact on AstraZeneca proposed pipelines Provide scenario with options and a risk - benefit analysis for AstraZeneca going forward

About AstraZeneca AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world s most serious diseases. But we re more than one of the world s leading pharmaceutical companies. Lead Regulatory Affairs & GRP Lead Reports to Director - Regulatory Affairs Position purpose For assigned products : Regulatory Acceleration process Plan to gain rapid and high-quality approvals and ensure a high standard of regulatory compliances, SEC/TC/APEX Preparation, in order to achieve the company s business objectives. Developing India-specific Artwork, Support to Regulatory dossier preparation and submissions like New drug applications, Site registration, Clinical trials and Import licence. Managing Registration samples right from dispatch of samples till the report. As part of a New drug application, ADC sample testing. Also follow up for reports, Licence Life cycle management. Revision of existing licenses, and artworks, where gaps are identified, for compliance with existing licenses. Facilitates a second review of external submissions. Handling of promo mats Internal customers Marketing, Sales, Logistics, Medical, Legal Affairs Intellectual Property, Global Product Teams (GPTs), Key Brand Teams (KBTs), International Regulatory Affairs (IRA), Manufacturing Sites and QA, Regional Office External customers CDSCO Office, NIB, IPC, CDTL, CDL, NCB, & DCK and other Local Health Authorities and other Government Agencies, Manufacturers, Local Trade Associations, Legal Professionals Minimum requirements Qualification : M.Pharm/B.Pharm/ 10-14 years Experience in India Regulatory function, knowledge of dossier compilation. He/ she should be well conversant with Indian regulations. Key Result Areas/ outputs Adherence to AZ and industry codes of conduct, ethics and good regulatory practices Ensure that all licensing for assigned products is complete in accordance with relevant norms Develop and implement action regulatory plans for allocated products to achieve requisite approvals rapidly and facilitate the rapid launch Provide Leadership and direction within project teams Assist in Issue Management Maintain the awareness of, and shape the regulatory environment relevant to the assigned products portfolio Competitive Intelligence and analysis Key Result Areas/outputs Activities Adherence to AZ and industry codes of conduct, ethics and good regulatory practices Align with the values and vision of AZ Ensure compliance with Local legislation, Global regulatory policies, AZ code of conduct, Corporate Governance and Audit requirement Ensure that company confidentiality is maintained (i.e. intellectual property, product information and strategic information) Disclose potential breaches of codes or conducts Key Result Areas/outputs Activities . Ensure that all licensing for assigned products is complete in accordance with relevant norms Monitor status of product licenses Manage changes in product licenses and coordinate with other changes, planned and in progress Maintain complete documentation records Communicate changes to licenses status promptly Develop and implement action regulatory plans for allocated products to achieve requisite approvals rapidly and facilitate rapid launch Maintain detailed knowledge of critical aspects of products: commercial strategies, the content of the dossiers, regulatory intelligence, regulatory timelines and supply strategy Ensure that local regulatory strategies are consistent with global product strategies and local priorities Develop regulatory plan in conjunction with key stakeholders and ensure allocation of adequate resources and deliver plans on time Track status and take prompt corrective measures whenever necessary to ensure rapid approval and launch Provide Leadership and direction within project teams Strive to ensure high levels of performance and achievements. Take decisions and accountability for actions. Build commitment within the team. Enhance positive attitudes and mindset. Demonstrate confidence and conviction. Challenge the status quo for continuous improvement. Help build an open and trusting atmosphere Assist in Issues. Interact with relevant regulatory authorities on a regular basis to facilitate the process of obtaining necessary approvals/permissions Monitor and understand the impact of external changes in the regulatory and political environment that will impact on the assigned products Communicate the impact of changes to key stakeholders. Influence key external stakeholders, in line with codes of conduct, to improve regulatory outcomes Develop excellent relationships and partnerships with Regulatory Authorities Competitive Intelligence and Analysis Monitor the global pipelines of competing pharmaceutical companies Analyse gathered the information for its impact on AstraZeneca s proposed pipelines Provide a scenario with options and a risk-benefit analysis for AstraZeneca going forward Key result areas/outputs Activities GRP Quality Lead Ensuring the GxP area(s) under their responsibility are run in accordance with external regulations. Ensuring appropriate levels of resources to complete GRP activities Providing/coordinating training and coaching in the related GxP area for the MC QMS Identifying/agreeing on areas of compliance risk and follow-up of any issues Ensuring GxP self-assessments in the corresponding GxP area Monitoring KPIs in the related GxP area and proposing remedial and improvement actions Establishing improvement priorities Monitoring internal/external factors such as emerging regulations or shifts in regulatory enforcement Identifying trends and communicating identified risks Establishing and maintaining business continuity plans in the corresponding GxP are Why AstraZeneca? At AstraZeneca we re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We re on an exciting journey to pioneer the future of healthcare. Date Posted 26-May-2025 Closing Date 30-Jul-2025

Career Category Clinical Job Description ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world s toughest diseases, and make people s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what s known today. What you will do Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information Work closely with cross-functional stakeholders to define redaction strategy, lead review and approval, ensure submission readiness, and hand off for timely submission or posting Ensure consistent quality across documents, ensure submission readiness, and hand off for timely submission or posting Communicate with team members to resolve problems and escalate issues Record and maintain written redaction strategy for the study and product Support trend analysis and process improvement What we expect of you Master s degree and 1 to 3 years of relevant experience OR Bachelor s degree and 3 to 5 years of relevant experience OR Diploma and 7 to 9 years of relevant experience Minimum of 2 years experience in preparing regulatory documents for public disclosure Familiarity with clinical research and clinical regulatory documents Knowledge of clinical trial disclosure regulations, guidelines, and best practices Basic Qualifications: Experience understanding and interpreting data/information and its practical application Self-motivated with developed skills in multi-tasking, attention to detail, and follow-through Ability to follow controlled processes Excellent spoken and written English Ability to negotiate and influence Project management skills, including ability to prioritize work in order to meet required deadlines Problem solving ability EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation. .