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
9 Apotex Research Executive Jobs
Executive, GRA PLCM
Apotex Research
posted 4mon ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
- Responsible for the product life-cycle management of Apotex products (Toronto) in identified markets.
- Maintenance of documentation/database records pertaining to approved products in line with systems, processes and procedures.
- Leading and/or coordinating regulatory affairs projects, as assigned.
- Preparation of submission and approval notifications for applications submitted to Regulatory agencies.
Job Responsibilities
- Responsible for providing support and regulatory guidance to a team in the completion of projects supporting regulatory submissions.
- Responsible for the preparation and review of quality regulatory PLCM submissions for various markets to ensure timely approval.
- Responsible for the maintenance and timely completion of regulatory documents to support regulatory compliance in various markets.
- Accountable for assessment, coordination and compilation of deficiency responses in a timely manner.
- Works with other functional areas to resolve issues related to information for regulatory submissions.
- Evaluate, prepare and review of post-approval supplements to manage the regulatory product life-cycle as applicable.
- Assessment of change control documents. Review of change control forms and provide accurate assessment for change being assessed (as applicable and assigned).
- Maintenance of regulatory databases to ensure accuracy of information. Maintain established trackers (Review checklist for PLCM/deficiency response, deficiency tracker, submission spreadsheet etc.) and ensure accuracy of information.
- Co-ordinate with third party manufacturers for document requirement for regulatory submissions.
- Act as a back-up for team members and support as when required.
- Timely communication and follow-up with the respective departments for compilation and submission of PLCM submissions and query responses to meet agreed timeline.
- Interpret and ensure compliance with SOPs, RA policies procedures and regulatory guidelines. Prepare and/or draft SOPs and regulatory guidelines (as applicable).
- Interact with other applicable departments within Apotex to discuss and provide solutions to regulatory issues and/or problems.
- Communicate with external sources such as agents and suppliers to request and/or provide data relevant to submissions.
- Works in a safe manner collaborating as a team member to achieve all outcomes.
- Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
- 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 policies.
- All other relevant duties as assigned.
Job Requirements
- Education:
- A Post-graduate/Graduate degree in Chemistry/ Pharmacy/ Life Sciences.
- Knowledge, Skills and Abilities:
- Candidate should have knowledge about Post-approval change submission requirement and compilation of variation packages for US/CAN/EU/AUS-NZ/ROW markets.
- Experience:
- Candidate should have minimum 3 years of experience in US/CAN/EU/AUS-NZ/ROW markets.
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 descriptionApotex Research Interview Questions & Tips
Prepare for Apotex Research Executive 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 Executive at Apotex Research are saying
Rating based on 25 Executive
reviews
Anonymous · Production & Manufacturing
in Mumbai
Likes
Culture and working environment.
Dislikes
Salary and compensation (Appraisal cycle) is not transparent process.
Read 25 reviewsExecutive salary at Apotex Research
reported by
117
employees
with 4-9
years exp.
₹4
L/yr - ₹10.3
L/yr
59%
more
than the average Executive Salary in India
View more details
What Apotex Research employees are saying about work life
based on 768 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
Share an Interview