Contract Regional Regulatory Affairs (Pharma) Manager - Starts June!
Recruit Express Pte Ltd| Date Posted: 21-Mar-2020
EA Licence No: 99C4599|EA Personal Registration No: R1875164
Bachelor's / Honours
- Gain and maintain regulatory approvals to allow product supply and ensure compliance within the ASEAN affiliate (Brunei, Hong Kong, Macau, Malaysia, Singapore, Thailand).
- Consolidate all the ASEAN countries requirements for more efficient submission process in the multiple ASEAN countries.
- Contribute to the submission strategy for product/indication registrations in ASEAN.
- Support the execution of competitive regulatory strategies for development of existing projects in order to shorten development time and obtain the most favorable outcome; including new molecular entities, biologics, parenteral formulations and combination products.
- Maintain focus on corporate goals while responding to the needs of product development and project in a flexible manner (e.g. immediate response to shifting project priorities and ability to adapt quickly to evolving situations).
- Prepare local submission packages for NDA applications, indication extension submissions, maintenance of licenses (including variations, license renewals, post-marketing commitments follow-ups, labelling revisions, preparation of responses to questions received from health authorities etc).
- Work with Global Regulatory Affairs to obtain all registration documents for local submissions and to formulate appropriate responses to questions from health authorities.
- Provide regulatory documentation support where needed (e.g. hospital listing, NPP application etc).
- Review and approve clinical trial label text.
- Support the promotional materials review processes in ASEAN.
- Collaborate closely with various cross functions in the preparation of product launches.
- Provide timelines and related information to Product Lifecycle Management, Supply Chain, Quality Assurance for planning and implementation of labelling and packaging changes.
- Management of Dear Healthcare Professional communication and working cross functionally with sales force on distribution.
- Support regional QA/RA/RMP/PV audits and CAPAs as necessary.
- Support the transitioning and managing of partner Regulatory Affairs service providers.
- Support the re-modelling of Pregnancy Prevention Programme in ASEAN.
- Represent Regulatory Affairs department in assigned project meetings and effectively communicate program development to senior regulatory management.
- Ensure project teams prepare high quality international filings/registrations and responses to Agency requests within established timelines.
- Responsible for management of regulatory reporting activities, including but not limited to: annual report, 4-monthly sales and importation report, PSUR submissions etc.
- Maintain up-to-date knowledge on regulatory requirements for the ASEAN region.
- Review departmental and interdisciplinary standard operating procedures and assist in the design of departmental policies; adherence to all of the above.
- Maintain regulatory systems and databases to support effective implementation of regulatory activities, so as to ensure timely registrations/variations and renewals of products.
- Bachelor’s Degree in Pharmacy, or equivalent, minimum 4 years of Regulatory Affairs experience dealing with innovative products, including drugs for hematology and oncology is preferred.
- Good working knowledge of drug approval process.
- Must be able to respond flexibly to changing project priorities and work assignments.
- Must be able to work independently and to identify, recommend solutions to problems.
- Must be able to work in an environment where individual initiative and accountability to the team are required.
- Familiarity with Microsoft Word and PowerPoint; ability to work both independently and within a team structure.
Interested candidates please submit your resume to [Click Here to Email Your Resume]
Alternatively, pls call Jace at 6736 3280
Jace Choo Oi Kei
Personnel EA License No.: R1875164
Recruit Express Pte Ltd (EA Licence No.: 99C4599)
Recruit Express Pte Ltd