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8 Job openings at Clinchoice
About Clinchoice

ClinChoice is a leading global full & functional service CRO, renowned for its exceptional product development and lifecycle management capabilities across the pharmaceutical, biotechnology, medical device, and consumer health sectors. With three decades of proven expertise and outstanding results, we excel in delivering top-tier services. Our deep regulatory expertise, clinical trial execution, and robust pharmacovigilance and biometrics capabilities position us as a trusted partner in global markets. ClinChoice proudly maintains a strong presence across the Americas, Europe, and Asia-Pacific, ensuring comprehensive support for our clients worldwide.

Senior Associate/Strategist - EMEA Non-OTC, RA

Kolkata, Mumbai, New Delhi, Hyderabad, Pune, Chennai, Bengaluru

2 - 5 years

INR 4.0 - 7.0 Lacs P.A.

Work from Office

Full Time

Responsibilities: Work with the regional RA team to prepare documents for the registration of OTC drugs and cosmetic products in non-EU countries. Provide regulatory support for select projects such as artwork maintenance and artwork support for legal department and other special projects on an as needed basis using a variety of systems internally Preparation and compilation of regulatory documentation for the registration and renewal of OTC drugs and cosmetic products for EMEA and local pool Support product registration in all EMEA regions including Nordics and Northern Cluster Manage regulatory action item (task) tables including mapping, coordination of regulatory inputs, and timing Work with Kenvue regional Skin Health & Essential Health regulatory team and/or Provider Project Manager to develop project implementation plans and manage workload planning to ensure on-time completion of projects and tasks. Creation of regulatory documents, e.g., ingredient list, regulatory clearance Manage all EU and UK cosmetics notifications Regulatory review of product specification and labeling Support Claim Table and MasterText creation Regulatory review of raw materials Regulatory review of materials change Regulatory review of formula composition Work with Kenvue cross functional partners to provide regulatory inputs for documents Regulatory review of product information file Prepare registration dossiers using regional data and liaising with manufacturing sites Support Kenvue local market contacts in their registration procedure as well as retrieving documents from APRs/GCCs Manage all cosmetic and femcare GCCs Complete market impact assessments Portfolio survey (where used of ingredients) Deliverables: Provision of weekly updates (at a minimum) to relevant Kenvue colleagues or Provider Project Manager Training off-shore colleagues with respect to raw material and formulation review and approval as well as ingredient list generation Ensuring that regulatory standards and timelines are met Creation and update of working practices for processes used between Outsource partner and North America Regulatory Affairs for Consumer products, using lessons learned approach Planning and tracking the status of ongoing regulatory projects Ensure that standards and timelines are met Use of regulatory database (RegPoint) and IT tools (GSS, CAPRI, Concerto, ArtWorks, Veracity etc.) Create and update working practices for processes used between Outsource partner and EMEA Regulatory Affairs, using lessons learned approach Plan and track resource levels required and used for regulatory support requested. Experience/Qualifications: Minimum B.S. Chemistry, Biology, or related fields Minimum of two years of experience working within a Regulatory Affairs Department (e.g., pharmaceutical, cosmetic, food supplements, etc.), with direct accountability for deliverables or a combination of direct Regulatory Affairs experience and specific interactions with a Regulatory Affairs Department by providing source documentation to CMC, Quality, or Regulatory Operations

Executive/Senior Executive - RMC

Kolkata, Mumbai, New Delhi, Hyderabad, Pune, Chennai, Bengaluru

3 - 7 years

INR 5.0 - 9.0 Lacs P.A.

Work from Office

Full Time

Roles & Responsibilities End to end request governance for raw material data management - On-time initiation (within 24h of request receipt), adherence to the standard turnaround time (TAT) for all requests Understand the objective of the request. If needed, seek clarification/project background/missing information for initiating the request Handling supplier communication effectively, highlighting delays in getting supplier information & on-time escalation Timely update & maintenance of the Global Request Tracker (GTR) - GTR must be utilized as the single global source of reference for the entire lifecycle of each request within RM data management Timely, effective and transparent communication with global stakeholders for all requests Technical expertise - High standard of technical understanding of regulatory requirements for raw materials within all categories of use (Cosmetics, OTC, Drugs, Food/Nutritional s etc.) Knowledge of toxicology & safety assessment related information for raw materials within all categories of use (Cosmetics, OTC, Drugs, Food/Nutritional s etc.). Maintain a strong collaboration with the Toxicology partners to learn & quickly adapt for information requirement from suppliers as per specific request needs Data varsity - right first-time information collection & validity of the high volumes of data incoming for all requests should be maintained Understand the end-to-end data connectivity across all systems & maintain high standard of data accuracy at the time of data entry in the systems Sustain an Ownership Mindset - Complete all requests, right-first time & on-time (within TAT) Ensure to meet the KPIs on quality & productivity consistently Soft skills required (must have) - Project/ Request management - Given the huge number of requests that flow in this project, efficiency in overall & individual request, time & task management is highly required Disciplined execution & ability to provide attention to detail - Should be fully focused and evaluate the information thoroughly and follow the process in disciplined way to ensure on time visibility to the stakeholders and flawless execution to meet the individual request timelines. Communication skills - Effective, timely and proactive communication with all internal & external (suppliers) stakeholders Problem solving - Understand the criticality of the problem & seek practical, time-bound solutions to overcome the challenge Critical thinking - Asking right questions, avoidance of redundant questions, steps, processes & learning from past experiences to extrapolate the lessons to other requests Sense of urgency & learning Agility - Understand the urgency and its impact to the business. Apply the learnings immediately in the ongoing and future projects/work. Agility & Resilience - ability to work under fast paced conditions, taking quick alignments for faster decision making

Senior Associate / Specialist - CMC, EU-OTC

Kolkata, Mumbai, New Delhi, Hyderabad, Pune, Chennai, Bengaluru

4 - 5 years

INR 6.0 - 7.0 Lacs P.A.

Work from Office

Full Time

Responsibilities: Submission support: Submission management support for MRP & DCP procedures, PSUSA submission, Renewals, Repeat use procedures, variations etc. Preparation and compilation of regulatory documentation for the registration, variation and renewal of OTC drugs for EMEA. Prepare cover letter, application form and relevant Module 1 documents for variations. Manage regulatory action item (task) tables including mapping, coordination of regulatory inputs, and timing. Work with regulatory team to develop project implementation plans and manage workload planning to ensure on-time completion of projects and tasks. Regulatory review of submission documents for compliance. Work with cross-functional teams or local affiliates for submission documents and verification of packages. Updating relevant submission tracker. PSUR submission support: Review of EURD updates Tracking licenses for DLP and PSUR submission. Review of draft PSUR document for accuracy of the data. Co-ordinate with different stakeholders for safety related information for PSUR Support submission and handling of queries for PSUR Renewal support: Tracking of licenses for registration and approval. Tracking of approval validity of licenses and renewal timelines. Planning for renewal submission. Co-ordination with cross-functional team for Renewal documentation. Co-ordination with Local RA lead for Renewal documentation and submission. Preparation of Renewal package. Submission of Renewal to health authority and post submission activity. Deliverables: Provide weekly updates (at a minimum or based on client requirement) to relevant colleagues or Project Manager on project status. Internal & Confidential [not for external circulation] Ensure that regulatory standards and timelines are met for all projects. Planning and tracking the status of ongoing regulatory projects Use of regulatory database and IT tools where relevant. Project review every quarter on performance feedback and scope of improvement. Experience/Qualifications: Minimum B.S. Chemistry, Biology, or related fields Minimum of 4-5 years of experience working within a Regulatory Affairs Department (e.g., parmaceutical, cosmetic, food supplements, etc.), with direct accountability for deliverables or a combination of direct Regulatory Affairs experience and specific interactions with a Regulatory Affairs Department by providing source documentation to CMC, Quality, or Regulatory Operations.

Consultant - MSDS Authoring

Bengaluru

1 - 5 years

INR 3.0 - 6.0 Lacs P.A.

Work from Office

Full Time

ClinChoice is seeking Skilled Consultant - MSDS, for 1 year contract. Requirement: 1. Prepare and submit product material safety data sheet (MSDS/SDS) in compliance with US, EU or other country-specific regulations, within the required timelines, in multiple languages. 2. Analyze the hazards and properties of components to determine the appropriate SDS classification in accordance with global regulatory standards. 3. Determine appropriate hazard assessments and SDS phrases based on the assessment. 4. The SDS shall be revised based on inputs/feedback provided. 5. Need to establish a structured process for preparing the SDS and clearly define the steps required to process each section for SDS authoring. 6. Mentor junior authors in the manual creation of MSDS and provide support in using various system or tools for the process. 7. Review completed SDSs. Qualification and experience: 1. Masters/bachelor s degree in science-related field. 2. 3-5 years prior SDS authoring experience with reputed service providers or MNC chemical manufacturing companies.

Associate MICC

Bengaluru

1 - 2 years

INR 3.0 - 3.0 Lacs P.A.

Work from Office

Full Time

Primary Responsibilities: Handle inbound and outbound calls for Adverse Events (AEs), Product Complaints (PCs) and Medical Inquiries (MIs) and non-standard inquires. Handle spontaneous and solicited reports, including identification of Adverse Events, Product Complaints / Medical Device complaints, legal complaints, product information, Medication errors and Special case scenarios. Respond to web-based medical inquiries and product complaints received from Health Care Professional and consumers concerning the safety and effective use of all marketed products within prescribed timelines. Follow-up directly with patients/consumers and health care professionals regarding MI/PC/AEs queries, or as per client SOPs. Able to generate follow-up letters and adequate information for product complaints, Adverse Event Monitoring (AEM) forms. Update all templates periodically for follow-up and send it to medical reviewer for approval. Manage and/or resolve customer complaints. Follow-up/reconciliation of discrepancies, as required. Identify and escalate issues to supervisors. Provide product and service information to customers, demonstrate good customer service. Research required information using available resources. Research, identify, and resolve customer complaints using applicable software. Route calls to appropriate resources, as needed. Document all call information according to Medical Information standard operating procedures. Complete call logs and reports. Candidate Profile: B. Pharm/M. Pharm/ Life Science graduate. Proficient in relevant computer applications 1-2 years of experience in a UK/US call Center environment Knowledge of customer service practices and principles Skillset required: Excellent verbal and written communication skills. Should demonstrate call etiquettes. Should be a good listener and have people skills, customer focus, attention to detail, professionalism and be a multi-tasker. Ability to handle stressful situation appropriately. Excellent data entry and typing skills.

Associate - RMC

Bengaluru

2 - 3 years

INR 4.0 - 5.0 Lacs P.A.

Work from Office

Full Time

CLINCHOICE PRIVATE LIMITED is looking for Associate - RMC to join our dynamic team and embark on a rewarding career journey Processing requisition and other business forms, checking account balances, and approving purchases. Advising other departments on best practices related to fiscal procedures. Managing account records, issuing invoices, and handling payments. Collaborating with internal departments to reconcile any accounting discrepancies. Analyzing financial data and assisting with audits, reviews, and tax preparations. Updating financial spreadsheets and reports with the latest available data. Preparation of operating budgets, financial statements, and reports. Reviewing existing financial policies and procedures to ensure regulatory compliance. Providing assistance with payroll administration. Keeping records and documenting financial processe

Strategist - Regulatory Affairs

Bengaluru

7 - 9 years

INR 9.0 - 11.0 Lacs P.A.

Work from Office

Full Time

Job Summary: Experience in Drug identification number (DIN), natural health products (NHP), Dietary Supplement & Cosmetic notification submission and amendment notification to Health Canada. Experience in Formula review and approval. Evaluation of Ingredient as per Canadian Environmental Protection Act (CEPA) and Ingredient Listing creation including fragrance and flavor certificate review. Expertise in Artwork review and drive for approval. Change control management from initiation to approval in coordination with cross function teams and drive to implement the changes timely. Authoring Product Risk Management of self-care products. Experience in product website update and e-commerce activities as per client need. Follow client documentation standards and best practices. Qualifications and desired skills: Minimum B.Sc/M. Sc. Chemistry, M. Pharmacy, or related scientific field. 7 - 9 years of working experience within regulatory affairs department (pharmaceutical, cosmetics, dietary supplements etc.) with direct accountability for deliverables. Work experience in Health Canada regulatory domain would be added advantage. Effective and clear communication. Quality oriented view with concise writing skills. Ability to multi-task effectively and work independently in a remote setting. Excellent written and verbal communication skills. Familiarity with Health Canada pharmaceutical/supplement guidelines and their scientific interpretation.

Sr. Medical Writer

Kolkata, Mumbai, New Delhi, Hyderabad, Pune, Chennai, Bengaluru

4 - 7 years

INR 10.0 - 11.0 Lacs P.A.

Work from Office

Full Time

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Clinchoice

Clinchoice

Clinchoice

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Pharmaceutical Manufacturing

Horsham Pennsylvania

1001-5000 Employees

8 Jobs

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