Job Summary

Company Name
Charterhouse Pte Ltd

Locations
Singapore

Experience
3 - 13 years

Key Skills
Regulatory Affairs,Pharmaceutical

Education
Bachelors/ Degree

Function
Pharmaceutical/ Biotechnology

Role
Other Pharma

Industry
Pharmaceutical

Posted On
13th Jun 2018





About Us

Charterhouse is an Australian owned executive recruitment consultancy, which has expanded its operations in Singapore in mid 2006. Charterhouse was formed by bringing together a number of the industry's most successful, experienced and professional, permanent and contracting recruitment consultants. By merging their vast, international experience the vision was to create a business built upon not just meeting expectations but consistently exceeding them, through dedication, passion and integrity. Charterhouse offers specialist services within the Accounting, Banking & Finance, Sales and Marketing, Technology, Industrial, Manufacturing and Engineering fields. 4 Battery Road Bank of China Building #33-01 SINGAPORE 049908 Tel: 65 6435 5600 Fax: 65 6438 1600 Email: apply@charterhouse.com.sg Website: www.charterhouse.com.sg Agency License Number: 06C3997

Job Title

Title: Regulatory Affairs Manager | Pharma MNC (Pharmacist Only)

Job Description

Responsibilities

  • Lead country drug team for new product registrations, license extensions, variations, renewals according to agreed timeline, and ensure approvals in a timely manner 
  • Develop and execute regulatory plans for new products and maintenance of licences/authorizations according to country business needs 
  • Compile regulatory documents for submission according to local requirements 
  • Review, edit and proofread regulatory documentation 
  • Track status and progress of regulatory documentation 
  • Assist in preparation, review and training if necessary of labelling, SOPs, and other departmental documents 
  • Monitor applicable regulatory requirements; assure compliance with the company’s and external standards 
  • Compile and prepare responses to regulatory authorities’ questions 
  • Support the local manufacturing facility where necessary 
  • Maintain regulatory files in a format consistent with requirements 
  • Establish communication and good working relationships within RA, other functions and the health authorities 
  • Maintain awareness of regulatory requirements 
  • Participate as an active team member of regional project teams as required 


Experience
  • Bachelor’s degree or country equivalent in pharmacy or related scientific discipline with 3-4 years regulatory experience in a pharmaceutical and medical device regulatory affairs role and leadership experience preferred 
  • Pharmacist license is a MUST 
  • Strong verbal and written communication and presentation skills 
  • Knowledge of regulations 
  • Ability to independently identify compliance risks and escalate when necessary 
  • Demonstrated interpersonal skills including strong negotiation skills 
  • Scientific knowledge 
  • Ability to manage complex projects and timelines in a matrix team environment 
  • Ability to multitask and prioritize 
  • Technical systems skills (e.g. word processing, spreadsheets, databases, online research) 
  • Proofreading and editing skills 


Please contact Ewen Poh at +65 6435 5616 or charterhousehealthcare@charterhouse.com.sg for a confidential discussion

EA License no: 16S8066 | Registration no: R1550486

Only successful candidates will be notified.

 

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