Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin, we are in shapes our lives, we are advancing dermatology for every skin story.

We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.

At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.

Further supporting our growth and innovation momentum, we are establishing a new Global Capability Center in Barcelona to deploy new capabilities to effectively support its global commercial and functional teams. Located in the upscale Eixample District in the heart of Barcelona, Galderma’s Global Capability Center offers numerous possibilities for professional development such as exposure to global and cross-functional projects and access to global career opportunities.

Job Title: IT Business Analyst - Clinical Development

Location: Barcelona

Job Description

We are looking for an experienced IT Business Analyst to support our R&D Clinical Development team. In this role, you will be responsible for bridging the gap between IT and clinical research teams, ensuring that our technology solutions effectively support our clinical trial processes. The ideal candidate will have a strong background in both IT and clinical development, with the ability to translate complex business needs into actionable IT requirements.

Key Responsibilities

Requirements Gathering and Analysiso

• Collaborate with stakeholders in clinical development to identify and document business and functional requirements for IT systems.
  
• Translate clinical development needs into detailed IT specifications, focusing on systems such as EDC (Electronic Data Capture), eTMF (electronic Trial Master File) and CTMS (Clinical Trial Management System).
  

Process Mapping and Optimization

• Map out and document current clinical development processes, identifying inefficiencies or opportunities for improvement.
  
• Propose and implement IT solutions to optimize clinical trial processes, enhancing efficiency and data quality.
  

System Implementation and Integration

• Evaluate, recommend, and support the implementation of IT systems that meet the needs of the clinical development team
  

• Ensure successful system integration, data migration, and customization, working closely with IT and clinical teams.
  

Stakeholder Management

• Understand customer and key stakeholders interests and concerns and guide and provide solutions to customers and key stakeholders
  
• May convince others to accept new concepts, practices, and approaches
  
• Assist in change management processes, providing support during transitions to new systems or processes.
  
• Prepares presentations and concepts to be presented to the functional community or leadership team
  

Validation and Compliance

• Lead or participate in system validation activities to ensure compliance with industry regulations (e.g., GxP, 21 CFR Part 11).
  
• Monitor ongoing compliance of IT systems, collaborating with QA and regulatory teams to address any issues.
  

Training and Support

• Develop and deliver training materials and sessions for clinical development teams, ensuring effective use of IT systems.
  
• Provide ongoing technical support and troubleshooting, working with IT support teams as needed.
  

Data Management and Reporting

• Collaborate with data management teams to ensure high data quality in clinical systems.
  
• Define reporting requirements and assist in designing reporting solutions that provide insights into clinical trial progress.
  

Project Management

• Coordinate IT projects within the clinical development area, ensuring timely and within-budget delivery.
  
• Identify and mitigate project risks, maintaining a proactive approach to problem-solving.
  

Continuous Improvement

• Stay informed about new technologies, industry trends, and regulatory changes impacting clinical development.
  
• Propose innovative IT solutions to enhance clinical trial efficiency, data integrity, and patient safety.
  

Collaboration with Vendors

• Manage relationships with external vendors, participating in the evaluation, selection, and management of third-party software and service providers.
  
• Assist in contract negotiations and reviews to ensure alignment with business and technical requirements.
  

Management Responsibility

• Individual contributor who may manage employees (rarely)
  
• May review the work and supervise other junior employees and validate peer's work (including external suppliers)
  

Skills & Qualifications

• Proven experience as an IT Business Analyst in the clinical development or related R&D areas (Medical Affairs, for instance).
  
• Strong understanding of clinical trial processes and related IT systems (e.g., EDC, CTMS, eTMF, eISF, RTSM, RBQM, eCOA, eConsent, Imaging) and software development lifecycle (SDLC)
  
• Experience managing IT projects in a regulated environment, with knowledge of GxP, 21 CFR Part 11, and other relevant regulations.
  
• Fluent in English
  
• Excellent communication and stakeholder management skills.
  
• Experience with system validation, process optimization, and project management.
  
• Familiarity with AI technologies such as natural language processing (NLP), predictive modelling, and machine learning algorithms applied to Clinical or Medical areas.
  
• Business Analysis certifications (e.g., CBAP, CCBA) or Project Management certifications (e.g., PMP, PRINCE2) are a plus.
  

What we offer in return

• You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base.
  
• You will receive a competitive compensation package with bonus structure and extended benefit package.
  
• You will be able to work in a hybrid work culture.
  
• You will participate in feedback Loops, during which a personalized career path will be established.
  
• You will be joining a growing company that believes in ownership from day one where everyone is empowered to grow and to take on accountability.
  

Process steps

• Send your CV in English.
  
• If your profile is a match, we will invite you for a first virtual conversation with Talent Acquisition.
  
• The next step is a virtual conversation with the hiring manager.
  
• The final step is a panel conversation with the extended team.
  

Our people make a difference

At Galderma, you’ll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.

Regulatory Affairs (RA) Department in a pharmaceutical industry is crucial for ensuring that the company complies with all applicable regulations and guidelines during the development, manufacturing, and marketing of pharmaceutical products. This department serves as a bridge between the pharmaceutical company and regulatory authorities.

Roles and Responsibilities of Regulatory Affairs

1. Regulatory Strategy:

   • Develop regulatory strategies for new product development and existing product maintenance.
   • Ensure compliance with global, regional, and local regulatory requirements.

2. Regulatory Submissions:

   • Prepare, compile, and submit dossiers to regulatory agencies for product approval, including:
     • Investigational New Drug (IND) applications.
     • New Drug Applications (NDA).
     • Abbreviated New Drug Applications (ANDA) for generics.
     • Marketing Authorization Applications (MAA) for global markets.
   • Handle post-approval submissions like amendments, supplements, and variations.

3. Liaison with Regulatory Authorities:

   • Communicate with agencies such as the FDA (USA), EMA (Europe), MHRA (UK), CDSCO (India), and others.
   • Respond to agency queries, deficiencies, or inspection findings.

4. Labeling and Advertising Compliance:

   • Review and approve product labels, leaflets, and promotional materials to ensure compliance with regulatory standards.
   • Monitor claims made in advertisements to prevent regulatory issues.

5. Clinical Trial Management:

   • Obtain approvals for clinical trials from regulatory bodies.
   • Ensure trial protocols and reports comply with Good Clinical Practice (GCP) guidelines.

6. Regulatory Intelligence:

   • Stay updated on changing regulatory environments and guidelines.
   • Interpret new regulations and ensure the company adapts accordingly.

7. Documentation and Record Management:

   • Maintain complete and accurate records of all submissions, approvals, and communications with regulatory agencies.
   • Ensure proper archiving for audits or inspections.

8. Product Registration and Renewals:

   • Handle the registration of products in various countries.
   • Manage renewals and maintain compliance with changing regulations.

9. Pharmacovigilance Compliance:

   • Collaborate with the pharmacovigilance team to ensure safety data is submitted as required.
   • Manage periodic safety update reports (PSURs) and adverse event reporting.

10. Regulatory Support for Product Lifecycle:

    • Provide guidance during product development to ensure regulatory compliance.
    • Handle variations, line extensions, and updates for approved products.

11. Audit and Inspection Readiness:

    • Support internal and external audits by regulatory bodies.
    • Ensure the company is always inspection-ready.

Importance of Regulatory Affairs in the Pharmaceutical Industry

• Ensures products meet quality, safety, and efficacy standards set by regulatory agencies.
• Facilitates timely approvals, reducing delays in product launches.
• Helps in avoiding non-compliance issues, which could result in penalties, recalls, or bans.
• Maintains the company’s reputation by ensuring adherence to ethical and regulatory standards.

are hiring for below positions!

Designation: Executive - IT

Exp: 4 to 5 Years into IT infrastructure & IT Compliances in Pharma Industry

Education: Any Graduates / Diploma Holders

Designation: Executive - Regulatory Affairs

Exp: 2 to 3 Years into Regulatory Affairs

Market: ROW

Education: B.Pharm / M.Pharm

Location: Ahmedabad

To Join our Dynamic team, Send your CV on hr@senorespharma.com

Urgent hiring for IT Recruiters

Role: IT Recruiters (US Recruiters can also apply)

Experience: 2 to 4 yrs into IT Recruitment

Skills: End to End recruitment, Strong knowledge on IT Technologies, Good communication skills, Strong

experience into contract staffing

Shift Timings: 7.30 AM To 4.30 PM

Location: Jubilee Hills, Hyderabad

Mode of interview: Face to Face

Note: Only shortlisted profiles will be lined up for interview 

Local Candidates only preferable

Interested candidates share resumes to radha.n@nygci.com

We at Pyramid Consulting, Inc. are hiring for hashtag India Staffing!!

TechnicalRecruiter with 1+ years of experience in core India Staffing, particularly with IT requirements (Niche skills).

This opportunity is based in Noida (Onsite).

If you're eager to join our team, don't hesitate to share your resume at tanishka.joshi@pyramidci.com

Role: IT Recruiters

Experience: 2 to 4 yrs into IT Recruitment

Skills: End to End recruitment, Strong knowledge on IT Technologies, Good communication skills, Strong experience into contract staffing

Shift Timings: 7.30 AM To 4.30 PM

Location: Guindy, Chennai and jublieehills, Hyderabad

Mode of interview: Face to Face

Note: Only shortlisted profiles will be lined up for interview

Local Candidates only preferable

Interested candidates share resumes to vaishnavi.t@nygci.com