Concordia International is the result of the acquisition by Concordia Healthcare Corp (now Concordia International Corp) of the AMCo group on 21 October 2015.The combined businesses are highly complementary to each other, with well established product portfolios, and provide a strong platform for future growth through acquisitions in line with its strategy to build a truly global pharmaceutical company.
Post : Regulatory Affairs Executive
MAIN PURPOSE OF ROLE:
- Provide Regulatory support and expertise within region (UK/Ireland, Europe or ROW)
-Work cross-functionally and in collaboration with key stakeholders/customers both internal (eg, Commercial, Technical, Quality, Medical, Supply Chain etc) and external (eg, Competent Authorities, Local Distributors & MA Holders, local Regulatory consultancy etc)
- Act as contact point/knowledge base for scientific & technical aspects of Module 3 (CMC (Chemistry, Manufacture & Control)) component documents and associated regulatory activities
- Management of allocated Marketing Authorisations and/or markets
KEY RESULTS AREAS (Core functional areas required to perform the job):
- Timely filing of complete, high quality post-approval Regulatory submissions; prompt, complete and accurate responses to Requests for Information (RFIs) and effective communication of approvals
a) Varying Authorisations (in markets that allow for this procedure).
b) Preparing and filing of Marketing Authorisation (MA) renewal applications as per renewal schedule in concerned markets.
c) Checking and reviewing product artwork for country specific regulatory compliance.
d) Updating, and being accountable for, all the project/planning status logs maintained within Regulatory Affairs.
e) Implementing and Complying with the SOPs in effect.
-100% accurate and complete recording of all regulatory submissions, correspondence with Competent Authorities and approvals and any associated log.
-All queries from internal and external customers are answered in accordance with Service Level Agreements (SLAs).
- Timely meeting of training targets & learning objectives as set by Manager.
- Providing technical knowledge of product Module 3 data to all other members of the Regulatory team and cross-functionally.
- Ensuring that Regulatory document management system contains the most current and accurate approved information.
KEY RESPONSIBILITIES AND ACCOUNTABILITIES:
- Ensuring support in the timely submission of new Marketing Authorisations (where applicable), changes of ownership, renewals and variations, their follow-up and approval in line with agreed timings (Manager and/or project plans).
- Ensure accuracy, completeness and quality of Regulatory submissions. Ensure that all submissions comply with the current Regulatory Legislation at all times.
- Ensure that MAs held comply with statutory requirements & Regulatory guidelines at all times.
- Ensure that all product information (SmPCs, PILs and artwork for package labelling) is updated when necessary and submitted to the Competent Authorities in correct format. Ensure that subsequent approved artwork is accurately recorded and communicated.
- Ensuring accurate recording and communication of Regulatory submissions, correspondence with Competent Authorities and final approval to ensure compliance.
- Ensuring accurate and timely responses to queries from internal and external stakeholders/customers
- Ensuring out of stock and back in stock positions and first launch after grant of MA for the products falling under their responsibility are notified to the relevant Regulatory Authorities.
- Carrying out any task delegated by Director/Unit Head/Manager which contribute to overall running of Regulatory Affairs team e.g. assistance with different ongoing projects. Accurate and timely delivery on projects.
- Participate in training activities for career development to attain a high level of competency in all aspects of Regulatory Affairs.
- Planning & management of all allocated projects and ensuring timely delivery of these projects.
- Direct communication with Regulatory Authorities to facilitate productive dialogue on submissions and issues activities for career development to attain a high level of competency in all aspects of Regulatory Affairs
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Qualifications:
Bachelors degree in Pharmacy or Life Science
Post-graduate qualification in a relevant scientific discipline
Experience & Competences
1-2 years experience in Regulatory Affairs within the pharmaceutical industryets in one or more of the three global regions (UK/Ireland, Europe, ROW)
Experience in technical aspects of pharmaceutical product manufacture
Thorough knowledge of Module 3/CMC documentation, including review of data used for Mod 3 preparation, authoring and compilation
Knowledge & Skills
- Knowledge of Regional & in-market Regulatory legislation/requirements Knowledge of technical aspects of product manufacture including quality control and compliance
- Ability to check and analyse scientific data and information provided for the purpose of regulatory activities such as variations
- Competent in dealing with manufacturers and third party companies with requests for data and resolution of manufacturing issues
- Experience of making Regulatory submissions in accordance with the European variations legislation (for UK & Ireland and Europe roles)
- Experience of making Regulatory submissions in accordance with local legislation (ROW roles)
- Competent use of grammatically correct written and spoken English Competency in other languages
- Knowledge of MS Office (Word, Excel, Outlook, PowerPoint), Adobe Acrobat and web applications.
- Competent maths skills
- Experience of working with electronic document management systems in a regulated environment
Candidate Profile :
• Clear communication style (written and verbal)
• Ability to work collaboratively and in a cross-functional environment
• Excellent attention to detail
• Logic and reasoning skills
• Effective planning, organisation and time management skills
• Customer-focused
• As per other AMCo core values
Additional Information:
Experience : 1-2 years
Qualification : degree in Pharmacy or Life Science
Location : Mumbai
Industry Type : Pharma
Functional Area : Regulatory Affairs
Last date : 30th September, 2016
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