Regulatory Affairs Executive/ Senior Executive

Permanent Position Singapore
17 Jan 2017
Expires on 31 Mar 2017

Company Description

Australian Pharma MNC

Posted by

Ewen Poh (R1550486 16S8408)

Tel

+65 6730 6188/ +65 9738 8821

Email

Job Description

Regulatory
  • Ensure that all company products comply with the regulatory and pharmacovigilance laws as specified by the Singapore Ministry of Health (MOH), Health Sciences Authority
  • Act as the nominated Responsible Person for the company in Singapore
  • Assist in the preparation of documentation of product applications for notification, variation, registration and renewal in accordance with company’s guidelines
  • Submit documentation for notification, variation, registration and renewal to the relevant

MOH Departments
  • Apply for and manage any activities on PRISM on company’s behalf
  • Liaise with relevant MOH departments in all regulatory matters such as Product Recall,
  • Post Market Surveillance, Pharmacovigilance etc
  • Maintain regulatory files and regulatory systems in accordance with company’s regulatory
  • procedures and SOPs
  • Ensure all documents in the regulatory file are updated in a timely manner
  • Participate in reviews for regulatory procedures and processes as required
  • Keep abreast of any new regulatory requirements and advise headquarter in Australia of any updates
  • in a timely manner

Responsible Person
  • Implement and maintain a Quality Management System that meets the standards and
  • requirements for Good Distribution Practice (GDP)
  • Management of authorised activities and accuracy of quality records
  • Coordinate recall operations for therapeutic products
  • Ensure timely response and action to customer complaints
  • Ensure that suppliers and customers are legally approved or authorised to enable lawful
  • supply of therapeutic products
  • Approve any subcontracted activities which may impact on GDP (such as redressing)
  • Implement and carry out regular internal audits to ensure GDP
  • Maintain records of corrective actions from internal audits and ensure that they are
  • implemented in a timely manner
  • Decide on the final disposition of returned, rejected, recalled or counterfeit products.
  • Approve any returns to saleable stock
  • Ensure that any additional requirements imposed on certain products by national
  • legislation (such as controlled drugs) are adhered to
  • Be contactable by the health authority by mobile phone and/or email
Customer Service Complaints and Returned Goods
  • Ensure that company’s Customer Complaints process is adhered to
  • Ensure that any adverse reaction to company product is reported to the Customer Services Manager within 3 working days of receipt
  • In consultation the Customer Services Manager, prepare, maintain and ensure adherence
  • to the SOPs relevant to the handling of customer queries, complaints and ADR’s in Singapore
  • Liaise with the Customer Services Manager in Australia to ensure defective products are returned for analysis
  • Assist Customer Services Manager in Australia to follow up Customer Complaints and
  • liaise with customers about the outcome of the complaint
  • On behalf of the Customer Services Manager, provide induction training for new
  • Singapore staff on company’s Customer Complaints procedure, maintain records regarding this
  • training and ensure the Customer Services Manager is informed on all trainings undertaken


Training & Continuous Education
  • Provide product training to internal staff and external customers (such as dermatologist
  • and pharmaceutical conferences, and pharmacy chains) as the need arises

Pharmacovigilance System

  • On behalf of the Customer Services Manager, provide induction training for new staff in
  • Singapore on company’s Pharmacovigilance System, maintain records regarding this training
  • and ensure the Customer Services Manager is informed on all trainings undertaken

Product Recall

  • Follow company’s product recall procedures as outlined in Product Recall SOP’s for Australia and Singapore
  • Work with the Recall Co-ordinator managing the recall from the company
  • Advise all relevant external parties such as Zuellig of the recall in accordance with the Product Recall SOP’s

Pharmacovigilance System

  • On behalf of the Customer Services Manager, provide induction training for new staff in Singapore on company’s Pharmacovigilance System, maintain records regarding this training and ensure the Customer Services Manager is informed on all trainings undertaken


Training & Continuous Education

  • Provide product training to internal staff and external customers (such as dermatologist and pharmaceutical conferences, and pharmacy chains) as the need arises

Including other duties as specified

Requirements

Education
A graduate with an honours degree in pharmacy. A postgraduate degree is not essential but would be an advantage. A strong understanding of chemistry and biology is essential. It would be a great advantage for the candidate to have studied pharmacology. Excellent report writing skills are essential.

Experience
  • Experience in regulatory affairs within the Singapore pharmaceutical industry is strongly preferred
  • A Constructive relationship with the Singapore Health Sciences Authority (HSA) would be an advantage
  • Experience in Quality Management Systems that meet the standards and requirements for Good Distribution Practice (GDP) would be an advantage
  • Experience in preparing Standard Operating Procedures (SOPs) would be an advantage
  • Proficiency in the following computer packages is essential: Microsoft Office (PowerPoint, Word, Excel)

Abilities

  • Resourceful
  • Diplomatic
  • Strategic
  • Outstanding verbal and written communication
  • An ability to compile a persuasive, logical and reasoned argument
  • An ability to present facts in a positive, persuasive and well-formatted manner
  • Logical problem solving aptitude
  • An ability to carry out self guided literature research
  • Report writing
  • An ability to work under pressure to ensure timelines and quality of results
  • Effective time management skills
  • An ability to self-motivate and work without constant supervision but with guidance when needed
  • Flexible approach regarding priorities
  • Ability to prioritise work
  • Good attention to detail
  • An ability to evaluate and analyse solutions
  • An ability to work within a team environment
  • An ability to interact effectively with staff throughout the company
  • Familiarity with PRISM e-services
  • Capable of meeting ad hoc requests within a short time frame
  • Willingness to accept company’s philosophy and values and Singapore’s Team Values
  • Willingness to work outside core hours when needed

Presentation
Dress and presentation must be professional and neat

Personality

  • Professional
  • Committed
  • Motivated
  • Positive
  • Creative yet logical
  • Honest
  • Punctual
  • Confident to interact with people
  • Intelligent

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