Add office photos
Engaged Employer
i
This company page is being actively managed by
Apotex Research Team. If you also belong to the team, you
can get access from
here
Apotex Research
Compare
All Filters
43 Apotex Research Jobs
Senior Analyst - GRA Labelling
1-6 years
₹ 3 - 8.3L/yr (AmbitionBox estimate)
This is an estimate of the average salary range for this
position. It has not been reviewed by the company, and
the actual salary may differ.
Mumbai
1 vacancy
Senior Analyst - GRA Labelling
Apotex Research
posted 1mon ago
Job Role Insights
Flexible timing
Key skills for the job
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.
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
Read full job descriptionPrepare for Senior Analyst roles with real interview advice
People are getting interviews at Apotex Research through
People are getting interviews through
(based on 18 Apotex Research interviews)
Referral
Company Website
Recruitment Consultant
Campus Placement
Walkin
Job Portal
11%
11%
11%
6%
6%
6%
49% candidates got the interview through other sources.
High
Confidence
?
High Confidence means the data is based on a large number of responses received from the candidates.
What people at Apotex Research are saying
Rating based on 14 Senior Analyst
reviews
Anonymous · Quality Assurance and Testing
in Mumbai
Likes
I love the challenge of working in a fast-paced environment and the opportunity to learn new things.
Dislikes
Nothing
Read 14 reviewsSenior Analyst salary at Apotex Research
reported by
85
employees
with 1-6
years exp.
₹3
L/yr - ₹8.3
L/yr
36%
less
than the average Senior Analyst Salary in India
View more details
What Apotex Research employees are saying about work life
based on 767 employees
Flexible timing
Monday to Friday
No travel
Day Shift
Apotex Research Benefits
View more benefits
Compare Apotex Research with
Sun Pharmaceutical Industries
Compare
Cipla
Compare
DRJ & CO
Compare
Biocon Limited
Compare
Glenmark Pharmaceuticals
Compare
Torrent Pharmaceuticals
Compare
Lupin
Compare
Zydus Lifesciences
Compare
Aurobindo Pharma
Compare
DIVI'S Laboratories
Compare
Viatris
Compare
Abbott
Compare
Novartis
Compare
AstraZeneca
Compare
Novo Nordisk
Compare
Thermo Fisher Scientific
Compare
Sanofi
Compare
Novartis Healthcare
Compare
Eli Lilly and Company
Compare
Merck
Compare
Similar Jobs for you
Research Scientist, Bio Analytical
2-4 Yrs
Hubli, Mangaluru, Mysuru / Mysore +2 more
Senior Officer, Stability Lab ( Documentation )
1-2 Yrs
Hubli, Mangaluru, Mysuru / Mysore +2 more
Sr. Officer-APIPL-Engineering & Maintenance
3-4 Yrs
Hubli, Mangaluru, Mysuru / Mysore +2 more
Sr.Officer, Commercial Stability Lab
2-4 Yrs
Hubli, Mangaluru, Mysuru / Mysore +2 more
Share an Interview