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Senior RA Associate, APAC - Pharmaceutical

Key Responsibilities
* Work closely with global and local regulatory counterparts to develop and implement regulatory submission plan for product registrations across Asia efficiently
* Ensure effective planning and execution of lifecycle regulatory activities including but not limited to renewals, CMC changes, labelling updates and fulfilment of post approval commitments
* Compile and/or prepare regulatory dossier or documents to fulfil local registration requirements in a timely manner
* Proactively review regulatory documentation and data, and identify/remediate potential gaps
* Plan and execute regulatory submissions to support clinical trial activities, where required
* Represent the region in global regulatory team/project meetings and ensure local requirements are well communicated and considered
* Ensure that regulatory related standard operation procedures are up-to-date and implemented by the countries
* Support regulatory audits and manage CAPAs, if any, through to completion
* Identify process improvements as appropriate to drive efficiency within the team
* Support regional or global regulatory projects as required
* Maintain relevant regulatory databases

Qualifications
* Degree in Pharmacy, Biological Sciences, Life Sciences or Pharmaceutical related studies.

Experience
* At least 3 years hands-on experience in regulatory function in the pharmaceutical industry with experience in supporting CMC submissions
* Good knowledge or experience in Asia region would be an advantage

Essential Skills and Abilities
* Meticulous and organized
* Able to prioritize work
* Ability to work on several projects at the same time with minimal supervision
* Excellent analytical skills and ability to think strategically with local, regional and global perspectives
* Strong interpersonal and negotiation skills and the ability to influence others without formal authority
* Strong communication skills, both written and verbal, with supervisors, colleagues, peers and external parties
* Strong functional and technical skills related to various dimensions of the regulatory affairs function
* Good spoken and written English

If you are interested in discussing further on the opportunity in a confidential manner, or other Regulatory Affairs opportunities in the pharmaceutical and medical devices industry, please contact Jennifer Ha at j.ha(@)realstaffing.com or contact +65 6871 4700.

Real, a trading division of SThree Pte Limited (Registration Number: 2007.20126E | SThree Pte Limited Licence Number 16S8216 | Real Licence Number 53132073A)

Award winner of:
International Recruitment Company of the Year by Recruitment International 2016

Life Sciences and Healthcare Recruitment Company of the Year by Recruitment International 2016

Best Overseas Operation by Gloabl Recruiters 2017

Application Email: JIHA.06174.3273@sthreesg.aplitrak.com
To be eligible to apply for this position you must be a Singapore Citizen or Authorized to work in Singapore.

Job Summary

Salary: $500 - $500 / month
Location: Bishan
Work Type: Full Time
Career Level: Not Specified
Education: Not Specified
Experience: Not Specified
Ref Number: RE-32737359
Date Posted: Feb 01 2018
Advertiser: Real Life Sciences