985 Regulatory Affairs Departments jobs in India

• Conduct pre-study, initiation, routine monitoring, and close-out visits for clinical trial sites.
• Ensure compliance with study protocols, GCP, ICH guidelines, and regulatory requirements.
• Verify the accuracy, completeness, and integrity of clinical trial data.
• Manage investigational product accountability and ensure proper handling and storage.
• Facilitate communication between study sites, the sponsor, and regulatory authorities.
• Train and support site staff on study procedures and data collection.
• Identify, track, and resolve site-level issues and discrepancies.
• Prepare site monitoring reports and ensure timely submission.
• Contribute to the development of clinical trial documentation.

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related scientific field.
• Minimum of 3-5 years of experience as a Clinical Research Associate.
• In-depth knowledge of Good Clinical Practice (GCP) and ICH guidelines.
• Experience with site management and monitoring activities.
• Proficiency in using electronic data capture (EDC) systems and clinical trial management systems (CTMS).
• Excellent understanding of medical terminology and disease processes.
• Strong communication, interpersonal, and negotiation skills.
• Ability to travel to study sites as required (may include occasional overnight stays).
• Detail-oriented with strong organizational and time management skills.
• Familiarity with various therapeutic areas is a plus.

• Lead the design and execution of innovative research programs focused on identifying and validating new drug targets.
• Develop and optimize experimental methodologies for drug discovery and characterization.
• Analyze and interpret complex biological data, drawing meaningful conclusions and informing future research directions.
• Manage and mentor a team of research scientists and technicians, fostering a collaborative and productive research environment.
• Stay abreast of the latest scientific literature, technologies, and trends in pharmaceutical research and development.
• Prepare and present research findings at internal meetings and external scientific conferences.
• Collaborate with cross-functional teams, including chemistry, pharmacology, and regulatory affairs, to advance drug candidates.
• Contribute to the development of intellectual property through patent applications.
• Ensure compliance with all laboratory safety regulations and ethical guidelines.
• Manage research budgets and resource allocation effectively.

• Ph.D. in Molecular Biology, Biochemistry, Pharmacology, Immunology, or a related life science discipline.
• 10+ years of post-doctoral and/or industry experience in drug discovery, with a strong emphasis on leading research projects.
• Demonstrated expertise in a specific therapeutic area (e.g., oncology, immunology, neuroscience) and proficiency in relevant experimental techniques.
• Proven track record of success in identifying and advancing drug candidates, evidenced by publications in high-impact journals and/or patent filings.
• Experience in mentoring and managing scientific teams.
• Excellent analytical, problem-solving, and critical thinking skills.
• Exceptional written and verbal communication skills, with the ability to present complex scientific information clearly.
• Proficiency in data analysis software and scientific databases.
• Ability to work independently and collaboratively in a fully remote setting.
• A passion for scientific innovation and a commitment to developing life-changing medicines.

• Lead and manage multiple drug discovery and development projects from target identification through preclinical candidate selection.
• Design and execute complex biological experiments and assays.
• Analyze and interpret experimental data, drawing robust conclusions and making informed decisions.
• Develop and validate novel assays for screening and target characterization.
• Oversee and contribute to in vivo pharmacology and efficacy studies.
• Collaborate with medicinal chemists to design and synthesize potential drug candidates.
• Contribute to the development of preclinical development plans, including formulation and toxicology studies.
• Mentor and guide junior scientists, fostering scientific excellence and professional growth.
• Prepare research reports, presentations, and publications for internal and external dissemination.
• Present research findings at scientific conferences and meetings.
• Collaborate effectively with cross-functional teams, including clinical development, regulatory affairs, and manufacturing.
• Manage relationships with external research partners and academic collaborators.
• Stay current with scientific literature and emerging technologies in relevant therapeutic areas.

• Ph.D. in Molecular Biology, Pharmacology, Biochemistry, or a related life science discipline.
• Minimum of 10 years of relevant postdoctoral and industry research experience in drug discovery and development.
• Proven track record of successfully advancing drug candidates from discovery to preclinical stages.
• Deep expertise in relevant therapeutic areas (e.g., Oncology, Immunology, Neuroscience, Infectious Diseases).
• Extensive experience with various biological assays, cell-based assays, and biochemical techniques.
• Strong understanding of pharmacokinetics, pharmacodynamics, and toxicology principles.
• Experience in leading research teams and managing complex projects.
• Excellent analytical, problem-solving, and critical thinking skills.
• Strong publication record and presentation experience.
• Exceptional written and verbal communication skills.
• Ability to work independently and collaboratively in a remote research setting.

• Lead and direct complex drug discovery and development projects within designated therapeutic areas.
• Develop and implement innovative scientific strategies to identify and validate novel drug targets and lead compounds.
• Oversee preclinical research activities, including in vitro and in vivo studies, pharmacology, toxicology, and ADME.
• Design and manage the progression of promising drug candidates through the development pipeline towards clinical trials.
• Provide scientific and strategic leadership to multidisciplinary teams of scientists and researchers.
• Interpret complex experimental data, draw sound conclusions, and make data-driven decisions regarding project progression.
• Author and review scientific publications, patents, and regulatory submissions.
• Collaborate with external partners, academic institutions, and key opinion leaders to advance research programs.
• Ensure research activities are conducted in compliance with regulatory guidelines (e.g., GLP, GCP) and ethical standards.
• Stay at the forefront of scientific advancements in pharmaceutical research and identify new opportunities for innovation.

• Ph.D. in Pharmacology, Molecular Biology, Biochemistry, Medicinal Chemistry, or a related life science discipline.
• Minimum of 10 years of progressive experience in the pharmaceutical or biotechnology industry, with a strong focus on drug discovery and preclinical development.
• Demonstrated success in leading R&D projects from discovery to IND-enabling studies.
• Extensive knowledge of drug discovery processes, assay development, and characterization techniques.
• Expertise in at least one major therapeutic area (e.g., Oncology, Immunology, Neurology).
• Proven ability to manage, mentor, and inspire scientific teams.
• Excellent strategic thinking, problem-solving, and decision-making capabilities.
• Outstanding written and verbal communication skills, with a strong publication and patent record.
• Experience in interacting with regulatory agencies is highly desirable.

• Design and execute complex experiments in areas such as molecular biology, cell biology, biochemistry, and pharmacology to identify and validate drug targets.
• Develop and optimize assays for screening potential drug candidates.
• Synthesize and characterize small molecules or biologics with therapeutic potential.
• Analyze experimental data, interpret results, and present findings to cross-functional teams and senior management.
• Contribute to the strategic direction of research programs and identify new research opportunities.
• Collaborate with internal teams and external partners (academic institutions, CROs) to advance research projects.
• Maintain a deep understanding of the scientific literature and emerging technologies in relevant therapeutic areas.
• Write and contribute to scientific publications, patents, and grant proposals.
• Ensure all laboratory activities comply with safety regulations and ethical guidelines.
• Mentor junior scientists and contribute to a collaborative research environment.
• Manage research project timelines and resources effectively.

• Ph.D. in Pharmacology, Molecular Biology, Biochemistry, Medicinal Chemistry, or a related life science discipline.
• Minimum of 6 years of post-doctoral research experience in the pharmaceutical or biotechnology industry.
• Proven track record of successful drug discovery and development contributions, demonstrated by publications in high-impact journals and/or patent filings.
• Extensive experience in relevant experimental techniques and methodologies (e.g., cell culture, Western blotting, ELISA, PCR, high-throughput screening).
• Strong understanding of disease biology and therapeutic modalities.
• Experience with data analysis software and statistical methods.
• Excellent critical thinking, problem-solving, and organizational skills.
• Strong written and verbal communication skills, with the ability to effectively present complex scientific information.
• Demonstrated ability to work independently and lead research projects in a remote setting.
• Experience in a specific therapeutic area (e.g., oncology, immunology, neuroscience) is a significant plus.

Primary Job Function:

To lead and manage all regulatory affairs activities at the manufacturing site located at Mumbai and LL locations, ensuring timely regulatory submissions, compliance with regulations, and providing strategic support to institutional and international business operations. The role is critical to maintaining business continuity and regulatory compliance.

Core Job Responsibilities:

Position Accountability/Scope:

Minimum Education:

B.Pharm / M.Pharm / M.Sc. or equivalent in pharmaceutical or life sciences discipline.

Minimum Experience/Training Required:

The opportunity

We’re looking for Manager with expertise in Computer System Validation and Stakeholder Management to join the leadership group of our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering.

Your key responsibilities

Skills and attributes for success

Governance and reporting

Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures.

Strong Knowledge on authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc.

Has supported Audits / Inspections

To qualify for the role, you must have

Ideally, you’ll also have

What we look for

A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills.

An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide.

Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries

What working at EY offers

At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are.

You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer:

EY | Building a better working world