At Roche, we believe passionately in what we do, and that our products make a real difference in people’s lives. We are a successful business that can offer exciting career opportunities to you both locally and internationally, in a supportive and rewarding culture. We know that our people are responsible for our success and we value our employees, aiming to create a work environment where feeling valued, respected and empowered is a daily experience.
Regulatory Affairs Associate
To work supportively under guidance from RA Director and managers in Regulatory activities in order to ensure all assigned regulatory tasks are fulfil within agreed timeline, in accordance with Roche & Industry code of conduct & practices, and also local regulations.
- Managing all assigned regulatory tasks comply with Roche standard and local regulations within agreed timeline.
- Monitoring and Following up all responsible activities/applications to be registered by target date.
- Provide assistance to RA director and/or managers to cope with regulatory affairs activities in compliance with internal and external guidance.
- Ensuring appropriate product life-cycle management in compliance with local regulations and company standards.
- Coordinating with other departments/divisions internally if regulatory advice is required under guidance of RA managers.
System Maintenance and Compliance
- Maintaining all applicable Roche systems complying Roche standards with accurate information as agreed timeline.
- Ensuring that the company practice conforms to local health regulations and company standards.
Communication, Technical Skills and Knowledge Share
- Establish and/or maintain relationships with health authorities
- Represent department at all appropriate cross-functional team meetings and communicated with key stakeholders as required to provide valuable regulatory expertise
- Represent department at required meetings and maintained communications on an ongoing basis
- Communicate key departmental information to internal and external customers according to the Regulatory Standards as required
- Attend external seminars and workshops as required and shared knowledge between team members
- Provide departmental training to Roche employee as required
- Bachelor’s degree of Pharmacy
- Minimum 2 years’ experience in RA field, especially pharma registration/variation in accordance with local regulation requirements.
- Computer skill is good (Microsoft Word, Excel, Power Point)
- Excellent in communication and negotiation skills both written & spoken English
- High ability to learn with good attitude
- Able to work independently and work as a team
The company offers a competitive package, reflecting the Candidate’s level of experience, performance expectations and qualifications. This will consist of base salary and other benefits.
Interested candidates, please send your update resume (in MS-Words file) with recent photo to HR Department at:
(Please state your current/expected package together with an interested position to apply)
For further information please contact,
Roche Thailand Ltd.
26th-27th Floor AIA Capital Center
89 Ratchadapisek Road, Dindaeng
Bangkok 10400 Thailand
Web site: www.roche.co.th
“Only shortlisted candidate(s) will be called in for an interview.”