Apotex Inc., founded in 1974, is the largest Canadian-owned pharmaceutical company. We employ over 6,000 people worldwide in research, development, manufacturing, and distribution. We produce more than 300 generic pharmaceuticals in approximately 4,000 dosages and formats and export to over 115 countries around the globe.
Post: Regulatory Associate
Job description
Job Summary
- Assist in preparation, co-ordination and timely implementation of regulatory activities in support of PLCM submissions and other operational and cross functional activities for the selected products and markets across Europe.
- Accountable for follow up activities, coordination of requests to and from EU RHQ maintaining efficient departmental communication and reporting.
- Conduct the peer review of pre-compiled e-CTD PLCM dossiers before final dispatch to EU RHQ.
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Job Accountabilities
Key Job Responsibilities
- Provide focussed support to assist to prepare right first time PLCM submissions to support changes and product life cycle pertaining to all relevant EU procedures & markets
- Support all required processes at various stages leading up to right first time PLCM submissions resulting in timely closure of the procedure and national approvals to ensure product supply continuity and quality for Europe
- Perform additional administrative duties (i.e. RIMS, Art. 57) as assigned by the Manager.
- Understand and comply to the internal training programs necessary for the Regulatory function.
Communication and relationship with Internal /External Customers & Stakeholders
- Frequent interaction with team members within the EU RHQ RA department and if required other applicable departments within the Apotex organisation to discuss and provide right solutions to regulatory issues and /or problems.
- Contribute to the creation and promotion of an environment of teamwork and empowerment.
Problem Solving Analysis
- Contribute to the solution of issues relating to the submissions.
Decision Making/ Autonomy
- Makes basic interpretation and basic application decisions relating to European regulatory guidelines and policies and internal regulatory best practices.
Leadership /Professional Development of Self & Others
- Address basic regulatory activities in support of submissions.
- Seek for guidance from Associate RA 8, Project Leader(s) and Manager(s) to enhance regulatory knowledge.
- Takes part in training and uses computerized systems (RIMS & Docubridge) to improve the exchange of regulatory and other information.
Compliance & Due Diligence
- Ensure compliance with SOPs as well guidelines, regulations and legislation pertaining to regulatory affairs.
- Adhere to and live by the company Quality values (P.A.I.D.)
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Candidate Profile
- University degree or equivalent in Pharmacy, Chemistry or Life Science.
- Minimum of 2 years regulatory experience with PLCM for Europe in the pharmaceutical industry.
- Proficient, fluent in spoken and written English, overall good communication skills
- Working times are in European time zone, from 8.00 am until 6.00 pm
- Computer literate, limited experience with European e-CTD submissions & compilations
- Basic experience with Track-Wise or equivalent regulatory database system
- Basic experience with Lorenz DocuBridge e-CTD system is a plus
- Basic regulatory experience with NPD related submissions for Europe is a plus
- Basic regulatory experience in general with Middle East, CIS and African submissions is a plus.
- Attention to detail, commercial driven, flexible and able to maintain composure at all times
- Good organisational and interpersonal skills, right-first-time mentality
Additional Information:
Experience: Min. 2 years
Qualification: B.Pharm, B.Sc
Location: Bangalore
Functional Area: DRA
Industry Type: Pharma
Employment Type: Full Time
Job Type: Regular
End Date: 25th September, 2015
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