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01 Jul 2020
Regional Regulatory Affairs Manager / Senior Manager
SingaporePermanent PositionA global, commercial-stage biotechnology company focus on discovering, developing, manufacturing and commercializing innovative medicines is seeking a Regulatory Affairs professional to manage regulatory activities for SEA region. Our ideal senior RA candidate for this role should have had prior pharmaceutical industry experience with good communication, negotiation skills and prescription product exposure.
Expires on 31 Jul 2020
- Obtain successful registration of new products and be compliant and effective with all product safety activities in SEA
- Manage and oversee all relevant maintenance activities potentially including Life Cycle Management strategy
- Collaborate and communicate effectively with teams internally and external bodies to meet business objectives
- Prepare, submit and support clinical trial applications including all related safety activities
- Maintain current knowledge of relevant regulations, including proposed and final regulations and provide regulatory affairs related information to other divisions and department
- Assist regulatory country lead to provide expert regulatory input to strategic decision making, including portfolio review, prioritization and external communications
- Assist regulatory country lead to develop and maintain standard operating procedures or local working practices
- Assist regulatory country lead to formulate and implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained
- Assist regulatory country lead to manage activities such as audits, regulatory agency inspections or product recalls
Posted ByChew Chia Ning (Reg No: R1657483)
Tel: +65 6738 email@example.com
- Pharmacy or Life Sciences qualification, or equivalent, with a minimum of 5 years prescription regulatory affairs experience. Licensed Pharmacist preferred.
- Knowledge of regulations of ASEAN region
- Outstanding written and oral communication skills, with ability to influence others and negotiate successful outcomes
- Ability to operate across a wide range of business activities and projects, including in-licencing and out-licencing projects
- Proactive, quick learner and self-starter
- Project management skills
Location : Home-based
If the above speaks to you, we’d love to hear from you. Please send in your updated CV to firstname.lastname@example.org (Chew Chia Ning, Reg No: R1657483) if you feel there is a fit with your experience and interest. You may also forward this interesting opportunity to someone who would be a great fit for this role.
All information will be kept strictly confidential. We regret to inform that only successful applicants will be contacted.
Kindly indicate your current/last salary details and your notice period
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