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Engaged Employer

Apotex Research

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4.1

based on 766 Reviews

3 Apotex Research Senior Analyst Jobs

Senior Analyst - GRA Labelling

APOTEX PHARMACHEM INDIA PRIVATE LIMITED

4.1

based on 766 Reviews

1-6 years

₹ 3 - 8.3L/yr (AmbitionBox estimate)

Mumbai

1 vacancy

Senior Analyst - GRA Labelling

Apotex Research

posted 1mon ago

Job Role Insights

Flexible timing

Key skills for the job

Analysts Recruitment MS Office PCR Product Life Cycle Management New Product Development

Job Description

Job Summary

Perform for all the labelling update and maintenance activities with respect to New Product Development Label creation and Product Life Cycle maintenance update for products in Canada Market. Interact with compilers for product allocated to understand any data related queries or data availability issues. Taking followups about the assigned projects from compilers. Co-ordinate with the vendor/affiliates to ensure the timely creation and update of the artwork. Interact on a peer level with ARPL colleagues and Canada affiliates for addressing Health Authorities requirement or queries.Maintain all the trackers for label to ensure the timely submission of the labels to health authority.

Job Responsibilities

Responsible for coordination & preparation of regulatory submissions and
Prepare and submit all the supporting documents for labelling submissions as per the type of submission for Canada
Co-ordinate with POC/ Vendor for Artwork creation and
Maintain all the tracking requirements for Label update (RIMS, Tracking sheets, CCR, )
Prepare and update the label/ Monograph as per the requirement in New Drug development or Product lifecycle maintenance in US and Canada
Develop & maintain regulatory knowledge of Canada
Manage the final product submissions and negotiate and communicate effectively with regional team/regulatory authorities to obtain timely product
Perform ESG submissions and maintain the
Author the responses and be a decision maker for the changes applicability in the labels
Review all the assigned tasks and ensure PM and form checklists is filled by both compiler and reviewer to maintain quality of submissons is
Define the priority of the labelling requirements and plan the submission based on priority.
Maintains user-level knowledge of labelling software s
Interacts with other internal departments when
Shows initiative to remain current on new labelling regulations and international guidelines and seeks guidance from Leader and management to enhance
Performs all work in accordance with all established regulatory and compliance and safety
Works in a safe manner collaborating as a team member to achieve all
Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and
Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR
All other relevant duties as
Train the new joinees on LAMS software and process related

Job Requirements

Education
- 2 years Masters in pharmacy with specialisation in Pharmacology
- 4 years Bachelors in Pharmacy
Knowledge, Skills and Abilities
Compilation of dossier submissions via eCTD
- Animal assays using dosing method, blood withdrawal tecnhniques, oral dosing techniques
- Molecular biology techniques: Gel electrophoresis, Plasmid and genomic DNA extraction, Transformation, Cloning and PCR.
- Computer Proficiency:
  - MS Excel, powerpoint proficient
  - Sound knowledge of MS Office, Internet, email
- An effective communicator with good presentation skills and organizational
Experience:
- 3 years 7 months- Apotex Research Private Limited, Global Business Services Job profile: Working in GRA Labelling Team as Senior Analyst
- 3 months- Saifee Hospital as Clinical pharmacist

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

Employment Type: Full Time, Permanent

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