regulatory scientist

ICON plc

<div>Senior Regulatory Scientist - Turkey<div></div><div>
ICON plc is a world-leading healthcare intelligence and clinical research organization. We&rsquo;re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development</div><div></div><div>
Completes country and, or regional Clinical Trial Regulatory deliverables according to study specifics, ICON policies, procedures, applicable regulations and the principles of ICH-GCP with sound scientific/technical principles in line with contractual agreement.</div><div><br>
Depending upon experience, become involved, when required, staff training/mentoring and contribute to the review of ICON systems and procedures as appropriate</div><div></div><div>
Responsibilities:</div><div>
Minimum of 3 years&rsquo; relevant regulatory experience<br>
Read, write and speak fluent English; fluent in host country language<br>
Travel less than 5%<br>
Recognize, exemplify and adhere to ICON's values which centre around our commitment to People, Clients and Performance<br>
As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs<br>
Ensure regulatory deliverables are performed in accordance with all relevant regulations, guidelines, policies and procedures within contractual timelines and budget with sound scientific/technical principles<br>
Advanced knowledge of ICON&rsquo;s SOPs/WIs, ICH, GCP and appropriate regulations<br>
Advanced knowledge of ICON systems applicable to role<br>
Advanced knowledge of country/region Regulatory Agency (RA), Central Ethics Committee (CEC) and other country-level authority clinical trial requirements, as applicable<br>
Input to strategic planning of submissions to RA, CEC and other country-level bodies, including proactive identification and mitigation of risks, as applicable<br>
Direct interaction with RA, CEC and other country-level bodies<br>
Ensure timely preparation/creation/adaptation/coordination/collation of submission pack/documentation according to applicable requirements<br>
Arrange internal/external review of submission/documentation according to project requirements<br>
Track and file central submission/approval progress in Clinical Trials Management System (CTMS), eTMF and other applicable systems ensuring accuracy and completeness of data/documents entered<br>
Perform translation management according to project requirements<br>
Manage submissions through lifecycle to approval in line with contractual agreement<br>
Maintain agreed timelines<br>
Ensure project team is informed of applicable clinical trial Regulatory submissions and approvals in accordance with project requirements<br>
Collaborate with other roles in-country/region to meet ICON&rsquo;s deliverables<br>
Ensure all project-specific training is completed on time, as applicable<br>
Adhere to study budget and proactively identifies out of scope activities<br>
Support the surveillance, collection, and maintenance of accurate, up-to-date clinical trial global/regional/country and regulatory clinical trial intelligence<br>
May mentor junior team members<br>
May contribute to the review of ICON systems and procedures as appropriate<br>
Any other duties deemed necessary to secure the success of ICON&rsquo;s business</div><div></div><div>
#LI-CL1</div><div></div><div>
What ICON can offer you:</div><div></div><div><div><div><div><div>
Our success depends on the quality of our people. That&rsquo;s why we&rsquo;ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.</div><div></div><div>
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.</div><div></div><div>
Our benefits examples include:</div><ul><li><div>
Various annual leave entitlements</div></li><li><div>
A range of health insurance offerings to suit you and your family&rsquo;s needs.</div></li><li><div>
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.</div></li><li><div>
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 family&rsquo;s well-being.</div></li><li><div>
Life assurance</div></li><li><div>
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.</div></li></ul></div></div></div></div><div></div><div>
Visit our <div>careers site</div> to read more about the benefits ICON offers.</div><div></div><div>
At ICON, inclusion &amp; belonging are fundamental to our culture and values. We&rsquo;re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.</div><div></div><div><div><div><div><div>
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know</div><div></div><div><div>
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless &ndash; there&rsquo;s every chance you&rsquo;re exactly what we&rsquo;re looking for here at ICON whether it is for this or other roles.</div></div></div></div></div></div></div><div></div>

Senior Regulatory Scientist - Turkey

Bayer

<div></div><div><div><b>At Bayer we&rsquo;re visionaries, driven to solve the world&rsquo;s toughest challenges and striving for a world where ,Health for all, Hunger for none&rsquo; is no longer a dream, but a real possibility. We&rsquo;re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining &lsquo;impossible&rsquo;. There are so many reasons to join us. If you&rsquo;re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there&rsquo;s only one choice.</b></div><br>
<div></div>
<div><b>
Formulation Analytical Scientist</b></div><div></div><div><b><br>
POSITION PURPOSE:</b></div><br>
<div>
</div><div>To provide Analytical and Formulation Development support for Regulatory Sciences and other business in Country and Global.</div><br>
<div></div>
<div><b>
YOUR TASKS AND RESPONSIBILITIES:</b></div><br>
<div></div>
<ul>
<li>Actively Participate in the development of analytical methods, validation and analytical work.
</li><li>Plan and execute storage stability / compatibility studies as per schedule and compile the data for submission to authorities
</li><li>Formulation development sample preparation for Regulatory Sciences and other businesses.
</li><li>Ensure smooth functioning of analytical instruments and ensure minimum down time
</li><li>Data compilation and archiving
</li><li>Adopt safe work practices and good housekeeping</li>
<li>Provide support to Packaging related activities.
</li><li>Follow timelines to meet submission schedules.
</li><li>Coordinate work with Regulatory and Registration colleagues
</li><li>Perform formulation trials, analyze products and send samples to field for biological evaluations</li></ul><br>
<div></div>
<div><b>
WHO YOU ARE:</b></div><br>
<div></div>
<ul>
<li>Master&rsquo;s degree in chemistry.
</li><li>Minimum 7-10 Years of working experience in pesticide testing laboratories, formulation development and analysis.</li>
<li>Practical knowledge of operating GLC/ HPLC / UV spectrophotometer and other advanced analytical instruments.
</li>Knowledge of packaging pesticides.<br>
<li>
 <br>
</li></ul><div><b>Competency</b></div><br>
<div></div>
<ul>
<li>Thorough knowledge of various pesticides, their formulations, Indian Regulatory requirements, FAO and CIPAC guidelines, ISO 9001 and ISO17025
</li><li>Computer Skills
</li><li>Analytical skills
</li>Interpersonal skills<br>
<li>
</li></ul><div></div><div><b>Ever feel burnt out by bureaucracy? Us too. That&rsquo;s why we&rsquo;re changing the way we work&mdash; for higher productivity, faster innovation, and better results. We call it Dynamic Shared Ownership (DSO). Learn more about what DSO will mean for you in your new role here </b><b>https://www.bayer.com/en/strategy/strategy</b></div><br>
<div></div>
<div><b>
Bayer does not charge any fees whatsoever for recruitment process. Please do not entertain such demand for payment by any individuals / entities in connection with recruitment with any Bayer Group entity(ies) worldwide under any pretext.</b></div><br>
<div></div>
<div><b>
Please don&rsquo;t rely upon any unsolicited email from email addresses not ending with domain name &ldquo;bayer.com&rdquo; or job advertisements referring you to an email address that does not end with &ldquo;bayer.com&rdquo;.</b></div><div><div><br>
<div>
</div><br>
<div></div><div><div><b>YOUR APPLICATION</b></div></div><br>
<div></div>
<div>
</div><br>
<div></div><div><div><div>Bayer is an equal opportunity employer that strongly values fairness and respect at work. We welcome applications from all individuals, regardless of race, religion, gender, age, physical characteristics, disability, sexual orientation etc. We are committed to treating all applicants fairly and avoiding discrimination.</div></div><br>
<div></div>
</div><br>
</div></div><div></div><div><div><br>
<div><div><b>Location:</b></div> <div>India : Gujarat : Vapi</div>
</div><br>
<div></div><div><div><b>Division:</b></div> <div>Crop Science</div>
</div><br>
<div></div><div><div><b>Reference Code:</b></div> <div>859567</div><br>
<div></div>
<div></div>
</div><br>
</div></div><div></div><div><div><br>
<br>
<div><div><b>Contact Us</b></div>
</div><br>
<br>
<div></div><div><div>+ 022-25311234</div></div></div></div></div>

Formulation Analytical Scientist

Columbia University

<div><ul><li>Job Type: Officer of Administration</li>
<li>Bargaining Unit:</li>
<li>Regular/Temporary: Regular</li>
<li>End Date if Temporary:</li>
<li>Hours Per Week: 35</li>
<li>Standard Work Schedule:</li>
<li>Building:</li>
<li>Salary Range: $70,000 - $80,000</li>
</ul><div><i>The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.</i></div><br>
<div></div>
<p></p>
<p>Position Summary</p>
<p>
Reporting directly to the Associate Director of Regulatory Science (the &quot;Associate Director&quot;) of the Clinical Trials Office (the &quot;CTO&quot;) of Columbia University's Vagelos College of Physicians &amp; Surgeons (&quot;P&amp;S&quot;) at Columbia University Irving Medical Center (&quot;CUIMC&quot;), the Regulatory Science Specialist assists the Associate Director in overseeing the CTO's regulatory compliance and providing assistance to the research community in the development and conduct of clinical trials.</p>
<p>
The CTO, which is operated jointly with the New York-Presbyterian Hospital (&quot;NYPH&quot;) assists investigators and academic/research staff in developing clinical trials at CUIMC and provides administrative resources and infrastructure to build and sustain clinical trials research.</p>
<p></p>
<p>Responsibilities</p>
<p>
The Regulatory Science Specialist is responsible for the following:</p>
<ul>
<li>Collaborates with the Associate Director, the Executive Director of the CTO (the &quot;Director&quot;), the Medical Director of the CTO, CUIMC faculty and administration and NYPH administration in meeting the institutional needs regarding clinical trial compliance, quality assurance, training and process-improvement goals.</li>
<li>Assists the Associate Director in developing and implementing policies and procedures designed to assure that clinical trials are carried out in compliance with applicable federal and state regulations, including those promulgated in the U.S. Food and Drug Administration, the U.S. Department of Health and Human Services, the Centers for Medicare and Medicaid Services and the rules of the Joint Commission.</li>
<li>Assists the Medical Director and Associate Director of Regulatory Science in implementing the IND/IDE Assistance Program, which provides regulatory guidance in connection with investigator initiated clinical trials.</li>
<li>Assists in the implementation of a training program for research personnel, including research newsletters, workshops, and didactic training sessions upon request.</li>
<li>Provides guidance regarding regulatory and institutional requirements to investigators and research personnel</li>
<li>Provides assistance and support in creating and maintaining www.ClinicalTrials.gov records in compliance with applicable regulations and policies.</li>
<li>Participates in the Clinical Trials Monitoring Assistance Program (CTMAP) that includes oversight and monitoring of investigator/coordinator compliance with standard operating procedures as they pertain to the conduct of FDA regulated clinical trials.</li>
<li>Collaborates with the CTSA and the HRPO/IRB in developing programs such as programs to increase patient recruitment and to address regulatory and compliance needs.</li>
<li>Provides support of RecruitMe Platform for the CUIMC research community including:</li>
<li>Coordinating with investigators and research teams in RecruitMe entry.</li>
<li>Developing training and process improvement projects, and other project management duties with RecruitMe.</li>
<li>Collaborating with the Director and Associate Director to implement objectives and workflow strategies for content maintenance on RecruitMe and other CTO websites.</li>
<li>Fulfilling reporting requirements for management, including metrics from Google Analytics data.</li>
<li>Monitoring external communications for social media websites.</li>
<li>Liaising with RecruitMe contacts, information technology (&quot;IT&quot;) groups, CTSA leadership, outside vendors and/or internal partners in research for needs related to RecruitMe and other CTO websites.</li>
Represents the Manager and Director in his/her absence and all other duties as assigned.<br>
<li>
</li>
</ul><p></p><p>Minimum Qualifications</p>
<ul>
<li>Bachelor's degree</li>
<li>At least 4 years of experience in conducting clinical research</li>
</ul>
<p></p><p>Preferred Qualifications</p>
<ul>
<li>In depth knowledge of federal, state and local laws and regulations and industry requirements and practices regarding the proper conduct of clinical trials:</li>
<li>Particular knowledge and experience in FDA matters, including regulations relating to INDs and IDEs</li>
<li>Expert working knowledge in GCP, patient safety standards and IRB regulations pertinent to clinical research</li>
<li>Demonstrable ability to collaborate with partners in research, investigators and coordinators</li>
<li>Excellent verbal and written communication skills</li>
<li>Excellent interpersonal and presentation skills</li>
<li>Strong computer skills required, including proficiency with content management systems, social media websites, Microsoft Office</li>
Ability to manage/handle multiple tasks, teams, and teamwork simultaneously.<br>
<li>
</li>
</ul><p></p><p>Equal Opportunity Employer / Disability / Veteran</p>
<p>
Columbia University is committed to the hiring of qualified local residents.</p></div>

Regulatory Science Specialist

United Pharma Technologies Inc

<div>
 <p>
  <strong>
   Job Title: QC Scientist
  </strong>
 </p>
 <p>
  <strong>
   Location: North Carolina (Onsite)
  </strong>
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Job Description:
  </strong>
 </p>
 <p>
  Seeking a
  <strong>
   QC Scientist
  </strong>
  with 2&ndash;5 years of experience in a regulated medical or pharmaceutical environment. The role involves routine quality control testing, GMP documentation, and support of laboratory investigations to ensure product quality and compliance.
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Responsibilities:
  </strong>
 </p>
 <ul>
  <li>
   Perform QC testing using techniques such as HPLC, GC, UV, FTIR, and wet chemistry
  </li>
  <li>
   Document and review results per GMP/FDA requirements
  </li>
  <li>
   Support OOS/OOT, deviations, CAPA, and method validation activities
  </li>
  <li>
   Maintain SOPs, lab records, and instrument documentation
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Requirements:
  </strong>
 </p>
 <ul>
  <li>
   BS/MS in Chemistry, Biology, or related field
  </li>
  <li>
   2&ndash;5 years QC lab experience in medical/pharma industry
  </li>
  <li>
   Strong knowledge of GMP and regulatory guidelines
  </li>
 </ul>
 <p>
 </p>
</div>


Quality Control Scientist

EPM Scientific

<div>
 <p>
  <strong>
   R&amp;D Scientist
  </strong>
 </p>
 <p>
  Are you passionate about science and organization? We're looking for a
  <strong>
   hands-on scientist
  </strong>
  who can also
  <strong>
   drive project coordination
  </strong>
  across R&amp;D and analytical initiatives. This role blends technical expertise with leadership in planning and communication.
  <br/>
  <br/>
 </p>
 What You'll Do
 <br/>
 <br/>
 <ul>
  <li>
   Track and manage R&amp;D and analytical projects, ensuring timelines and priorities are met.
  </li>
  <li>
   Maintain project dashboards and prepare concise progress updates for leadership.
  </li>
  <li>
   Support formulation experiments, sample prep, and analytical testing (HPLC, dissolution, stability).
  </li>
  <li>
   Collaborate with QA, Regulatory, and Operations to align deliverables.
  </li>
  <li>
   Recommend process improvements and help implement standardized tools.
   <br/>
   <br/>
  </li>
 </ul>
 What We're Looking For
 <br/>
 <br/>
 <ul>
  <li>
   <strong>
    Education:
   </strong>
   Bachelor's or Master's in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field.
  </li>
  <li>
   <strong>
    Experience:
   </strong>
   3-6 years in pharmaceutical R&amp;D, analytical chemistry, or formulation science.
  </li>
  <li>
   Familiarity with HPLC and method development.
  </li>
  <li>
   Strong organizational and communication skills.
  </li>
  <li>
   Comfortable balancing lab work with coordination responsibilities.
   <br/>
   <br/>
  </li>
 </ul>
 Why Join Us
 <br/>
 <br/>
 <ul>
  <li>
   Competitive salary + comprehensive benefits.
  </li>
  <li>
   Health, dental, vision coverage.
  </li>
  <li>
   Retirement plan with company match.
  </li>
  <li>
   Paid time off and holidays.
  </li>
  <li>
   Collaborative, science-driven environment.
  </li>
 </ul>
</div>


R&D Scientist

Bioport Solutions

<p>We are seeking a motivated <b>Scientist/ Senior Application Scientist (Biotechnology)</b> to join our <b>Product Development Team</b>. This role involves hands-on work in <b>kit preparation, ELISA, electrophoresis, DNA/protein extraction, troubleshooting</b>, and <b>client interactions</b> across India. You will contribute to developing high-quality biotech kits while providing on-site technical support to clients.</p><p><b>Key Responsibilities</b></p><p><b>Laboratory Work &amp; Kit Development</b></p><ul><li>Prepare and optimize <b>biotechnology kits</b> (e.g., DNA/RNA extraction, protein purification).</li><li>Design and perform <b>ELISA assays</b>, <b>gel electrophoresis (SDS-PAGE, agarose)</b>, <b>Cell culture</b> and <b>chromatography</b>.</li><li>Conduct <b>quality control (QC) tests</b> on reagents and kits.</li><li>Troubleshoot technical issues in <b>sample processing, extraction, and assay workflows</b>.</li></ul><p><b>Documentation &amp; Compliance</b></p><ul><li>Maintain detailed records of <b>experimental protocols, QC data, and client reports</b>.</li><li>Ensure compliance with <b>ISO or other regulatory standards</b> (if applicable).</li></ul><p><b>Cross-Functional Collaboration</b></p><ul><li>Work with <b>R&amp;D, manufacturing, and sales teams</b> to refine product workflows.</li><li>Attend <b>scientific conferences, exhibitions, and networking events</b> to promote products.</li></ul><p><b>Qualifications &amp; Skills Essential:</b></p><ul><li><b>Bachelor&rsquo;s/Master&rsquo;s degree</b> in <b>Biotechnology, Biochemistry, Molecular Biology, or related field</b>.</li></ul><p>Hands-on experience with:</p><ul><li><b>DNA/RNA extraction</b> (e.g., column-based, magnetic bead kits).</li><li><b>DNA Cloning/PCR/Gene Expression</b></li><li><b>ELISA</b> (indirect, sandwich, competitive).</li><li><b>Cell Culture</b></li><li><b>Electrophoresis</b> (agarose, SDS-PAGE).</li><li><b>Protein purification</b> (affinity chromatography).</li><li>Strong <b>analytical and troubleshooting skills</b>.</li><li>Willingness to travel <b>up to 40%</b> (client visits across India).</li></ul><p><b>Preferred:</b></p><ul><li>Familiarity with <b>PCR, qPCR, or NGS workflows</b>.</li><li>Knowledge of <b>regulatory standards</b>.</li><li>Fluency in <b>English + regional Indian languages</b> (Hindi etc.).</li></ul><p>Work Place: IIDC KOSI KOTWAN, NABIPUR Mathura, Uttar Pradesh, 281403</p><p>Job Types: Full-time, Permanent</p><p>Pay: ₹9,154.29 - ₹20,000.00 per month</p><p>Work Location: In person</p>

Scientist/Senior Application Scientist (Biotechnology)

Venus Remedies Limited

<div>
 <p>
  <strong>
   Lead Scientist &ndash; Formulation &amp; Development (Small Molecules / Sterile Injectables)
  </strong>
 </p>
 <p>
  <strong>
   Role Summary
  </strong>
 </p>
 <p>
  Venus Remedies is seeking a Lead Scientist &ndash; Formulation &amp; Development (Small Molecules) to lead sterile injectable development for new off-patent small molecules and non-hormone/non-steroid parenteral products. The role spans feasibility through commercial readiness, with strong ownership of complex injectable generics, safety-enhanced reformulations, and IND-enabling formulations for differentiated molecules.
 </p>
 <p>
  A core expectation is deep, hands-on capability in troubleshooting and lifecycle strengthening of high-value sterile products across oncology and non-oncology portfolios.
 </p>
 <p>
  <strong>
   Key Responsibilities
  </strong>
 </p>
 <p>
  <strong>
   Sterile Injectable Development (Core)
  </strong>
 </p>
 <ul>
  <li>
   Lead end-to-end formulation development of parenteral dosage forms: solutions, suspensions, lyophilized products, complex/combination injectables.
  </li>
  <li>
   Execute pre-formulation studies: physicochemical characterization, solubility &amp; pH profiling, excipient compatibility, forced degradation, and stability risk mapping.
  </li>
  <li>
   Apply QbD/DoE to define CQAs/CPPs, build robust control strategies, and ensure scalable, reproducible formulations.
  </li>
  <li>
   Select excipients scientifically with clear rationale aligned to global regulatory expectations.
  </li>
 </ul>
 <p>
  <strong>
   Safety-Enhanced Reformulation / Platform Molecules
  </strong>
 </p>
 <ul>
  <li>
   Lead formulation programs aimed at reducing toxicity / improving tolerability of established antimicrobial or critical-care injectable classes via formulation and delivery approaches.
  </li>
  <li>
   Develop IND-ready drug products for novel derivatives/platform molecules, ensuring rapid concept-to-clinic translation.
  </li>
 </ul>
 <p>
  <strong>
   Troubleshooting &amp; Lifecycle Management (Must-Have)
  </strong>
 </p>
 <ul>
  <li>
   Independently troubleshoot sterile products prone to instability or manufacturing challenges.
  </li>
  <li>
   Solve issues such as precipitation, pH drift, degradation, incompatibility, particulate formation, lyophilization defects, container-closure interactions, and cold-chain deviations.
  </li>
  <li>
   Drive product robustness, manufacturability enhancement, cost optimization, and post-approval changes.
  </li>
 </ul>
 <p>
  <strong>
   Other deliverables
  </strong>
 </p>
 <ul>
  <li>
   Lead pilot/scale-up batches and transfer processes to GMP sites.
  </li>
  <li>
   Review/approve batch records, transfer protocols, PPQ readiness packages, and process risk assessments.
  </li>
  <li>
   Author/review dossier sections covering formulation rationale, process design, controls, stability, and lifecycle change strategies.
  </li>
  <li>
   Provide strong scientific responses to regulatory queries.
  </li>
  <li>
   Mentor scientists/associates; review protocols, raw data, and reports.
  </li>
  <li>
   Manage deliverables, timelines, and budgets.
  </li>
 </ul>
 <p>
 </p>
 <p>
  <strong>
   Qualifications
  </strong>
 </p>
 <ul>
  <li>
   Ph.D./M.Pharm/MS in Pharmaceutics/Pharmaceutical Sciences.
  </li>
  <li>
   10+ years in sterile injectable formulation &amp; development including lyophilized products.
  </li>
  <li>
   Strong record in off-patent small molecules, complex generics, and commercial troubleshooting.
  </li>
  <li>
   Expertise in QbD/DoE, excipient science, stability design, scale-up, process optimization and tech transfer.
  </li>
  <li>
   Knowledge of ICH and global regulatory expectations
  </li>
 </ul>
</div>


Formulation Scientist (Small Molecules / Sterile Injectables)

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