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Sub-Regional RA Associate, Pharmaceutical and Devices

Reporting to: Regulatory Affairs Manager

Location: Singapore

Job Summary
* Responsible for registrations activities in the region.
* Responsible for maintenance of regulatory systems and databases.
* Responsible for review of promotional materials and sponsored events in the region.
* Responsible to ensure the standard operational procedures are up-to-date and implemented by the countries.
* Any other department activities as assigned.
* Responsible for maintenance of regulatory systems and databases.
* Responsible for maintaining registration records, post-approval obligation tracking
* Responsible for co-ordinating, gathering and updating regulatory information.

Key Responsibilities

1. Product Registration
* Preparation of submissions to the local health authorities for new products and variations to existing products in line with Marketing launch plans, with guidance from senior regulatory colleagues as necessary.
* Maintains regulatory systems and databases to support effective implementation of regulatory activities to ensure timely registrations/variations and renewals of products.
* Effective implementation of regulatory activities to ensure timely registrations of new products.
* Prepares monthly report and slide for team and cross functional meetings.

1. Processes and Compliance
* Coordinates and implement the regulatory work processes to ensure timely registrations of new products.
* Perform, review and approval of advertising, promotional material and sponsored events according to local regulation and code of conduct.
* Ensure that Regulatory related standard operation procedures are up-to-date and implemented in the countries.
* Provide timely and accurate input to regulatory assessments of products where requested.
* Maintain an awareness of new legislation, policies and guidelines impacting the assigned product portfolio and regions.

1. Organizational Effectiveness
* Contribute to an effective regulatory affairs organization in line with corporate, functional and local objectives.
* Develop regulatory intelligence network and maximize opportunities to expedite registration processes in each country
* Build constructive relationships with the local health authorities by compiling and submitting high quality submissions and providing prompt responses to questions
* Contribute to continuous review and improvement of processes within the department to ensure consistent, efficient and effective practices across the team

Qualifications
* Degree in Pharmacy, Biological Sciences, Life Sciences or Pharmaceutical related studies.
* Registered Pharmacist with the Singapore Pharmacy Board, desirable.

Experience
* At least 2-3 years hands-on experience in regulatory affairs function in the pharmaceutical and/or medical device industries.
* Good knowledge of the regulation, regulatory systems and landscapes in the regions.

Essential Skills and Abilities
* Ability to work effectively and collaboratively cross functionally and with global and country regulatory colleagues.
* Ability to develop and maintain strong relationships both internally and externally
* Result oriented, ability to work in a fast-paced environment, independent and proactive.
* Commitment to meet the needs of global and local stake holders.
* Meticulous and organized.
* Demonstrated ability to handle multiple projects.
* Strong interpersonal and negotiation skills to influence others without formal authority.
* Strong communication skills, both written and verbal, with supervisors, colleagues, peers and external parties.
* Good spoken and written English
* Ability to communicate and read Malay is an advantage

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)

Monthly Salary: SGD 5200

Application Email: JIHA.47197.3273@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

Category & Subcategory:
Healthcare and MedicalPharmaceuticals
Salary: $5,200 - $5,200 / month
Location: Central Area
Work Type: Full Time
Career Level: Not Specified
Education: Not Specified
Experience: Not Specified
Ref Number: RE-32694342
Date Posted: Aug 28 2017
Advertiser: Real Life Sciences