44 Pharmaceutical jobs in Hyderabad
Central CRA (Clinical Research Associate)- Registries

Posted 5 days ago
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+ undefined
+ _Hiring Manager:_ **_Project Lead - ESR and Grants_**
+ _Location:_ **_Hyderabad_**
· _% of travel expected:_ **_Travel required as per business need_**
· _Job type:_ **_Permanent and Full time_**
About the job
**Our Team:**
_Sanofi Business Operations (SBO) is an internal Sanofi resource organization based in India and is setup to centralize_ processes _and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations? in Sanofi, globally._
_The Sanofi Business Operations is built to reduce reliance on external service providers and facilitate the development of internal expertise. The Sanofi Business Operations will leverage an untapped combination of talent pool._
**Main responsibilities:**
The Central CRA serves as the primary liaison for the Principal Investigator and other site staff involved in conducting rare disease registries at the investigational site.
**1.** **Feasibility Activities:**
o Involvement in the site selection process together with the Registries Team.
**2.** **Study Start-up Activities:**
o Assist in the collection of site documents for the Health Authority (HA)/Regulatory Authority (RA) submission and Ethics Committees (EC)/ Institutional Review Board (IRB)
o Review and check the quality of the site and study documents to submit with IRB/EC central, local, hospital committee and HA/RA.
o Prepare EC cover letter and any additional materials required (if applicable)
o Ensure appropriate follow-up with EC for additional questions and to inform sites. (if applicable)
o Prepare the Insurance Certificate application when applicable.
o Assist from the Site Contract process with the collection of the site documents required, to the budget negotiation and final agreement with the sites.
o Ensure Inform Consent Form (ICF) customization based on country requirements, incorporate site details, and perform appropriate quality review and version tracking per site. (if applicable)
o Assist with the upload & file of Study Start-up documentation into the eTMF.
o Ensure that all parties are informed about project progress, changes, and any issues that arise.
+ **Site Monitoring:**
+ **Off-Site Visits**
+ Perform remote site management and other related activities on assigned registries in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs.
+ Plan, prepare, conduct, report and follow up site (and satellite sites) remote visits - Site Selection, Site Initiation, Routine Monitoring and Close Out Visits according to Study manual, Protocol, Local Regulation, Good Clinical Practice (GCP) and SOPs.
+ **Onsite (where local hub affiliates are located)**
+ Perform onsite site management and other related activities on assigned registries in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs.
o Plan, prepare, conduct, report and follow up Onsite site (and satellite sites) visits - Site Selection, Site Initiation, Routine Monitoring and Close Out Visits according to Study manual, Protocol, Local Regulation, Good Clinical Practice (GCP) and SOPs.
o **Management of the Site Data:**
o Reviews study data from various sources remotely.
o Follow up of trial progress and quality control of data (source document check). Review of electronic Case Report Form (eCRF) completeness and query resolution by the sites. Escalate issue(s), when necessary. To maintain contact with Data Management group. To coordinate international data collection projects.
**4.** **Site Management:**
o Recruitment Follow up on patient enrolment and patient status.
o Site facility & staff: Assure that site facilities are adequate, according to protocol needs, local regulations, GCP and applicable SOPs (global/local). Assure site staff training and access to different systems.
o Develops collaborative relationships with investigational sites and other stakeholders as applicable.
o Liaise with Vendor for different activities (startup, onsite monitoring).
**5.** **Safety & Quality:**
+ Assure adequate safety reporting process of the site, and that site is submitting and/or
+ undefined
+ Quality control of study conduction at site level - with "Audit/inspection readiness" mindset. Critical analysis of issues and deviations (root cause analysis) and implementing Corrective and Preventive Actions (CAPA) whenever necessary.
**6.** **Study administration:**
+ To maintain all the tables, trackers and databases updated to follow the study progress
+ undefined
+ To know and use all the tools needed.
+ Participates in the investigator payment process, if applicable
+ To ensure TMF compliance by contributing to the eTMF process during the entire study duration (from the set-up to the archiving) in collecting site documents required.
+ Study Meetings: To participate with the rest of the study team in local and international investigators and/or monitors meetings (where required), study/operational meetings, quality audits and inspections for the registries, study set-up meeting and trainings.
+ undefined· **People:** (1) Seek alignment with internal stakeholders, External stakeholders, or Principal Investigator to ensure integration and appropriate prioritization of Registry study activities, and compliance with approved processes; (2) Support team initiatives and objectives, identify and recommend process improvements and initiatives, and participate in company initiatives with the primary objective of adding value to the businessundefined **Performance:** (1) Maintain study Start-Up Timelines and Monitoring Visit Frequency and Quality which includes adherence to the monitoring plan, thoroughness of data verification, and timely resolution of issues (2) Data Quality and Integrity: accuracy and completeness of data collected at the sites. This can be assessed through the number of data queries raised and resolved, and the frequency of data discrepancies (3) Regulatory Compliance: maintaining compliance with regulatory requirements. Adherence to Good Clinical Practice (GCP) guidelines, and proper documentation. (4) Patient Recruitment and Retention: effectiveness in supporting patient recruitment and retention efforts. (5) Communication and Collaboration: ability to communicate effectively with site staff, sponsors, vendors, and regulatory bodies. This includes responsiveness, clarity of communication, and the ability to resolve conflicts. (6) Training and Development: commitment to ongoing professional development and training. This can be measured by participation in training programs and staying updated with industry best practices. (7) Efficiency in Reporting: maintaining the timeliness and accuracy of the CRA's reports, including monitoring visit reports, progress reports,
+ **Performance:** (1) Maintain study Start-Up Timelines and Monitoring Visit Frequency and Quality which includes adherence to the monitoring plan, thoroughness of data verification, and timely resolution of issues (2) Data Quality and Integrity: accuracy and completeness of data collected at the sites. This can be assessed through the number of data queries raised and resolved, and the frequency of data discrepancies (3) Regulatory Compliance: maintaining compliance with regulatory requirements. Adherence to Good Clinical Practice (GCP) guidelines, and proper documentation. (4) Patient Recruitment and Retention: effectiveness in supporting patient recruitment and retention efforts. (5) Communication and Collaboration: ability to communicate effectively with site staff, sponsors, vendors, and regulatory bodies. This includes responsiveness, clarity of communication, and the ability to resolve conflicts. (6) Training and Development: commitment to ongoing professional development and training. This can be measured by participation in training programs and staying updated with industry best practices. (7) Efficiency in Reporting: maintaining the timeliness and accuracy of the CRA's reports, including monitoring visit reports, progress reports,
· **Stakeholder:** (1) CRAs identify all relevant stakeholders, including sponsors, investigators, regulatory bodies, and patients. Understanding each stakeholder's role and influence is essential. (2) Communication: Effective communication is vital. CRAs ensure that stakeholders are kept informed about the study's progress, any issues that arise, and the outcomes. This involves regular updates, meetings, and reports. (3) Building Relationships: Establishing and maintaining positive relationships with stakeholders is crucial. This involves understanding their needs, expectations, and concerns, and addressing them promptly. (4) Conflict Resolution: CRAs often mediate conflicts between stakeholders. They must be adept at negotiating and finding solutions that satisfy all parties involved. (5) Compliance and Ethics: Ensuring that all stakeholders adhere to regulatory and ethical guidelines is a key responsibility. CRAs monitor compliance and address any deviations promptly. (6) Feedback and Improvement: Gathering feedback from stakeholders and using it to improve processes and outcomes is an ongoing task. This helps in building trust and improving future collaborations.
About you
+ **Experience** :
+ 3+ years of experience in Clinical research & development including clinical trial monitoring experiences. Rare diseases or observational studies, real world evidence experience will be a plus.
+ Attention to Detail: Critical for monitoring trial data and ensuring accuracy.
+ Problem-Solving: Ability to address and resolve issues that arise during trials.
+ Project Management: Skills in managing timelines, budgets, and resources.
+ Technical Writing: Proficiency in writing reports, protocols, and regulatory documents.
+ Experience in working in global projects and international matrix environment.
· **Soft skills** :
+ Communication: Excellent written and oral communication skills to interact with various stakeholders.
+ Adaptability: Ability to adapt to changing requirements and environments3.
+ Interpersonal Skills: Building and maintaining positive relationships with stakeholders3.
+ Time Management: Efficiently managing time and prioritizing tasks.
+ Ethical Judgment: Strong sense of ethics and integrity in conducting clinical research.
· **Technical skills:**
+ Good Clinical Practice (GCP): Understanding and adherence to GCP guidelines.
+ Regulatory Requirements: Knowledge of regulatory requirements and guidelines (FDA, EMA, etc.).
+ Clinical Trial Processes: Familiarity with clinical trial phases, protocols, and methodologies.
+ Data Management: Skills in data collection, analysis, and reporting.
+ Medical Terminology: Proficiency in medical terminology and procedures.
+ Competent with Microsoft Office products.
+ undefined
+ **Education** : Degree in a Pharma/scientific discipline or a related Life science degree
+ undefined· **Languages** : High Proficiency in written and spoken English.Pursue progress, discover extraordinary.Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.Watch our ALL IN video ( and check out our Diversity Equity and Inclusion actions at sanofi.com ( !
**Pursue** **_progress_** **, discover** **_extraordinary_**
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video ( and check out our Diversity Equity and Inclusion actions at sanofi.com ( !
Global Terms & Conditions and Data Privacy Statement ( is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting or via our movie We are Sanofi ( an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (
Pharmaceutical Sales Representative
Posted today
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Company Description
At Chemintra Life Sciences, we take pride in being a trusted intermediary and API manufacturer & Distributor serving leading pharmaceutical companies in India and China. Expanding our vision, we have recently ventured into non human consumption products. This diversification showcases our commitment to innovation and excellence across various industries.
Role Description
This is a full-time, on-site role for a Pharmaceutical Sales Representative located in Hyderabad. The role involves day-to-day tasks such as developing and maintaining relationships with Indian pharmaceutical Businesses, supporting our growth story in China, promoting Chemintra's pharmaceutical products (Domestic), meeting sales targets, and keeping up-to-date with product knowledge and industry trends. The representative will also be responsible for strategizing and implementing sales plans to drive business growth.
Qualifications
- Experience in sales, including maintaining client relationships and achieving sales targets
- Knowledge of the pharmaceutical industry and product management
- Strong communication and presentation skills
- Ability to research and stay informed about industry developments and competitors
- Self-motivated with the ability to work independently and as part of a team
- Capability of hitting product specific targets.
- Bachelor's degree in Business, or a related field
- Experience in B2B sales.
Director of Regulatory Research & Intelligence – India (Pharmaceutical & Medical Devices)
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Job Title: Director of Regulatory Research & Intelligence
Location: Hybrid (Hyderabad)
Industry: Life Sciences / Healthcare Technology
Experience Level: 10+ years
Employment Type: Full-time
About the Role
Kamet Consulting Group is seeking a high-impact Director to lead our Global Regulatory Research & Intelligence function while driving strategic business development and market penetration. This dual-role leader will oversee a high-performing research intelligence team and own commercial growth initiatives, leveraging regulatory expertise to win new business, deepen client relationships, and expand our footprint in priority geographies.
The ideal candidate brings proven quota achievement over their tenure, deep knowledge of global regulatory frameworks, and the ability to translate regulatory insight into competitive advantage and revenue growth.
Core Responsibilities
· Regulatory Leadership & Intelligence Oversight
- Lead, mentor, and grow a multidisciplinary Regulatory Research & Intelligence team; set clear performance, quality, and delivery metrics.
- Define and evolve research agendas aligned to emerging regulatory trends (FDA, EMA, CDSCO, TGA, WHO, ICH, etc.) and client priorities.
- Oversee execution of complex regulatory intelligence projects—ensuring on-time, on-budget, and in-scope delivery.
- Serve as senior authority on regulatory intelligence, ensuring compliance with global quality standards and minimizing client risk.
- Present complex regulatory implications and recommendations to senior executives in clear, commercially relevant language.
Business Development & Market Penetration
- Develop and execute a go-to-market strategy to penetrate new regions and sectors within life sciences and healthcare technology.
- Leverage regulatory expertise to identify and secure high-value consulting, advisory, and outsourced service engagements.
- Own revenue targets and consistently achieve or exceed sales quotas through proactive pipeline building, solution selling, and account expansion.
- Partner with Leadership to position Kamet as a thought leader in global regulatory affairs.
- Negotiate and close complex, multi-year contracts with C-suite and senior decision-makers.
Cross-Functional Collaboration
- Collaborate closely with consultants, SMEs, and leadership across clinical, quality, supply chain, labeling, and M&A advisory services.
- Align business development activities with operational delivery to ensure client satisfaction and repeat engagements.
Required Qualifications
· Education: Advanced degree in Pharmacy, Life Sciences, Regulatory Affairs, or related field; PhD or MBA preferred. RAC or equivalent certification a plus.
· Experience:
- 10+ years in regulatory affairs, regulatory intelligence, or compliance within pharma/medical devices.
- 5+ years in consulting with direct client-facing and team leadership responsibilities.
- Proven track record of meeting or exceeding business development quotas and delivering measurable revenue growth.
· Regulatory Expertise: Mastery of global and Indian regulatory frameworks (FDA, EMA, CDSCO, WHO, ICH, GMP, GCP, QMS).
· Commercial Acumen: Skilled at identifying market opportunities, shaping client solutions, and closing strategic deals.
· Leadership: Demonstrated success in managing high-performance, multicultural teams.
· Communication: Exceptional English written and verbal skills with the ability to distill technical concepts for executive audiences.
Desired Traits
· Entrepreneurial, growth-oriented mindset with a balance of technical and commercial skills.
· Ability to operate seamlessly between strategic planning, operational oversight, and hands-on business development.
· High ethical standards and commitment to excellence in client delivery.
About Kamet Consulting Group
Kamet Consulting Group is a Life Sciences Management Consulting firm providing Strategic Advisory, Implementation, Capability Building, and Outsourced Services to Pharmaceuticals, Medical Devices, Digital Health, and Consumer Health companies across their value chain. We are an equal opportunity employer. All qualified applicants are encouraged to apply.
Why Join Us
- Contribute to meaningful technology in the life sciences domain.
- Work with a collaborative, forward-thinking team committed to innovation.
- Competitive compensation and benefits package.
- Flexible working arrangements and growth opportunities.
Assoc. Mgr / Senior Regulatory Affairs / Regulatory Intelligence Lead (Pharmaceutical and Medical...
Posted today
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Ideal Candidate is an Immediate Hire
(Hiring for Multiple Positions)
Job Description:
It's an exciting time to join Kamet Consulting Group as we continue our hyper growth journey. We encourage entrepreneurial culture, spirit, which empowers individuals to think creatively, take initiatives, and drive innovative solutions.
We are looking to fill multiple open roles for Associate Manager through Senior Regulatory Affairs / Regulatory Intelligence Lead (Pharmaceutical and Medical Devices) specializing in Pharmaceuticals and Medical Devices supporting monitoring, analyzing, and interpreting regulatory changes and developments within the pharmaceutical and medical device industries. This position involves staying abreast of evolving regulatory requirements, guidelines, and standards to ensure compliance and mitigate regulatory risks for the organization.
This is an exciting opportunity to work within our management consulting directly interacting with customers to build bespoke solutions to solve their business problems. The candidate will collaborate with our content matter experts and consultants while gaining a detailed understanding of internal and external data sets (e.g., registrations data, health authority correspondence, regulatory intelligence, etc.)
Kamet Consulting Group is a Life Sciences Management Consulting firm providing Strategic Advisory, Implementation, Capability Building, and Outsourced Services to Pharmaceuticals, Medical Devices, Digital Health, and Consumer Health companies across their value chain.
Our expertise spans across organizational and functional areas of Deals, R&D, Clinical, Regulatory, Quality, Labeling, Safety, Supply Chain, and Commercial. We pride ourselves in bringing extensive experience and professionalism to every engagement and customize our support to our client’s individual needs and opportunities. We encourage entrepreneurial culture, spirit, which empowers individuals to think creatively, take initiatives, and drive innovative solutions.
At Kamet Consulting Group, we strive to create a strong and inclusive workforce by actively seeking a diverse pool of applicants. We firmly believe in providing equal opportunities to all qualified candidates, without any discrimination based on factors such as race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Responsibilities
- Monitor Regulatory Landscape: Stay updated on regulatory changes, trends, and developments specific to the pharmaceutical and medical device industries.
- Conduct Research: Research and analyze regulatory requirements, guidelines, and policies issued by regulatory authorities, such as the FDA (Food and Drug Administration), EMA (European Medicines Agency), and other relevant agencies worldwide.
- Assess Implications: Evaluate the potential impact of regulatory changes on pharmaceutical and medical device manufacturing, distribution, labeling, and marketing practices.
- Provide Insights and Analysis: Summarize and interpret regulatory information to provide actionable insights and recommendations to internal stakeholders, including regulatory affairs teams, compliance officers, and product development teams.
- Regulatory Compliance Support: Collaborate with cross-functional teams to ensure understanding and compliance with applicable regulations and requirements governing pharmaceutical and medical device products.
- Risk Assessment: Identify regulatory risks and vulnerabilities related to product development, manufacturing processes, and post-market surveillance. Propose strategies to address and mitigate regulatory risks effectively.
- Documentation and Reporting: Maintain accurate records of regulatory updates, analysis reports, and compliance documentation specific to pharmaceutical and medical device regulations. Prepare and present regulatory intelligence reports as needed.
- Stay Informed: Continuously monitor industry best practices, emerging trends, and regulatory enforcement actions relevant to pharmaceuticals and medical devices. Provide training and updates to internal stakeholders as necessary.
Qualifications and Skills:
- Bachelor's degree in Pharmacy, Life Sciences, Regulatory Affairs, or a related field. Advanced degree or professional certification (e.g., RAC - Regulatory Affairs Certification) is preferred.
- Proven experience (typically 2-5 years) in regulatory affairs, regulatory compliance, or a related role within the pharmaceutical or medical device industry.
- Strong understanding of regulatory frameworks, laws, and compliance requirements governing pharmaceuticals and medical devices, including Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Quality Management Systems (QMS).
- Excellent research, analytical, and critical thinking skills with the ability to interpret complex regulatory information and assess its implications for product development and commercialization.
- Detail-oriented with strong organizational and documentation skills.
- Effective communication skills, both written and verbal, with the ability to convey regulatory insights and recommendations to diverse stakeholders.
- Ability to work independently, prioritize tasks, and meet deadlines in a fast-paced, highly regulated environment.
- Proficiency in utilizing regulatory databases, research tools, and software applications for data analysis and reporting.
Other skills
- Consulting experience with an ability to interface directly with clients
- Ability to work in an agile environment and critical thinking while working with customers to deliver the final solution
- Adept at conducting research
- Competencies with Powerpoint and advanced Excel
- Self motivated
Required Qualifications:
- Advanced degree preferred
- Minimum of 4-6 years of work experience related within the pharmaceutical and/or medical device industry
- Prior lifesciences consulting experience especially leading projects within M&A, Regulatory Affairs, Labeling, and Supply Chain is preferred
Benefits:
- Competitive salary and benefits package
- Opportunity to work on groundbreaking projects with Top Organizations
- Professional development and growth opportunities.
- Hybrid work options
How to Apply:
We thank all applicants for their interest; however, only those selected for an interview will be contacted.
Global Regulatory Affairs Specialist
Posted today
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The International Program Regulatory Manager is a key role that supports the timely execution of registration plans for assigned portfolios in international countries. This position works under the supervision of the International Program Regulatory Director and partners with international regulatory teams and global line functions to drive registration strategies.
The IPRM is accountable for recognizing and resolving high-priority topics to ensure timelines and objectives of registration plans are met. They use global, regional, and country sources to maintain relevant databases on country requirements, pipeline information, and registration plans across all international markets.
Main Responsibilities- Registration Strategy Execution
- Provides input into registration strategies for international countries and drives the execution of registration plans as defined in the international RA subteam and in partnership with countries, regional roles, and global line functions as applicable.
- Maintains up-to-date contact country contact lists for programs and countries in scope.
- Pipeline Information Management
- Supports the IPRD in partnering with DU RA roles to obtain, digest, and communicate efficiently pipeline information to relevant stakeholders.
- Ensures updates to registration plans are performed timely and with the necessary quality.
- Efficiency Initiatives
- Supports and implements initiatives to enhance efficiency in ways of working and functional excellence.
- Geographic Expansion Support
- Supports the IPRD in the execution of geographic expansion plans for international countries.
- Information Dissemination
- Drives the dissemination of information to and education of global roles on international country/region requirements.
- Cross-Functional Initiatives
- Supports the implementation of functional or cross-functional initiatives, particularly those with potential impacts on international RA resources or FTE allocations.
- Degree in Science (e.g., Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent.
- Minimum of 2 years in Regulatory affairs in a country, regional, or global regulatory setting.
- Experience in regulatory license maintenance and new product registrations.
- Ability to work in a cross-functional environment.
- Experience in project management.
- Highly committed and team-oriented.
- Ability to recognize potential regulatory issues, complex situations, sound risk assessment, and overcoming hurdles.
We offer a dynamic and supportive work environment, opportunities for professional growth and development, and a competitive compensation package.
About UsWe are a leading healthcare company dedicated to improving and extending people's lives. Our purpose is to reimagine medicine to make a meaningful difference in people's lives.
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