Snr. Regulatory Affairs Specialist (APAC)
Singapore - Marsiling Update time: October 29,2019
Job Description
Job Title: Snr. Regulatory Affairs Specialist APAC, Specialty Diagnostics Group (SDG)
Reports to: Solid to Snr. Manager, Regulatory Affairs
Department: Regulatory Affairs
Location: Singapore (Preferred) or Malaysia
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $24 billion and approximately 70,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support.
All of our employees share a common set of values - Integrity, Intensity, Innovation and Involvement. Our ability to grow year after year is driven by our ability to attract, develop and retain world-class people who will thrive in our environment and share in our desire to improve mankind by enabling our customers to make the world healthier, cleaner and safer.
If you share in our values and if you're looking for an employer who is strongly committed to developing talent and rewarding achievement, come grow with us at Thermo Fisher Scientific.
Position Summary:
The SDG APAC Regulatory Affairs team are the Enabler and Strategic Business Partner for the Specialty Diagnostics Group of Thermo Fisher Scientific, who contributes to the growth in the region, driving the right strategic decisions for effective regulatory pathway to optimize the time to market. The Senior Regulatory Affairs Specialist will be working proactively with the Commercial and/ or Business Leaders from the regions in Asia Pacific, exclude China, on the expansion of the product portfolio and regulatory plan for the Specialty Diagnostics Group and also work with the Divisional and Country Regulatory Affairs Leaders to ensure that the optimal regulatory strategy meet the required legislation in the specific countries, to be registered for market access in an efficient and effective manner.
Key Responsibilities:
Education and Experience Requirements:
Knowledge, Skills and Abilities:
IT Skills:
Other Important Information
At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. Apply today http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Reports to: Solid to Snr. Manager, Regulatory Affairs
Department: Regulatory Affairs
Location: Singapore (Preferred) or Malaysia
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $24 billion and approximately 70,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support.
All of our employees share a common set of values - Integrity, Intensity, Innovation and Involvement. Our ability to grow year after year is driven by our ability to attract, develop and retain world-class people who will thrive in our environment and share in our desire to improve mankind by enabling our customers to make the world healthier, cleaner and safer.
If you share in our values and if you're looking for an employer who is strongly committed to developing talent and rewarding achievement, come grow with us at Thermo Fisher Scientific.
Position Summary:
The SDG APAC Regulatory Affairs team are the Enabler and Strategic Business Partner for the Specialty Diagnostics Group of Thermo Fisher Scientific, who contributes to the growth in the region, driving the right strategic decisions for effective regulatory pathway to optimize the time to market. The Senior Regulatory Affairs Specialist will be working proactively with the Commercial and/ or Business Leaders from the regions in Asia Pacific, exclude China, on the expansion of the product portfolio and regulatory plan for the Specialty Diagnostics Group and also work with the Divisional and Country Regulatory Affairs Leaders to ensure that the optimal regulatory strategy meet the required legislation in the specific countries, to be registered for market access in an efficient and effective manner.
Key Responsibilities:
- Work proactively with Country Commercial and Sales team to support the expansion of the product portfolio and work with Country Regulatory & Quality Leaders to develop the regulatory plan and regulatory strategy.
- Provide or propose measurable inputs into the regulatory strategy for the earliest possible approvals of go-to-market in the region to support the organization’s strategies.
- Reviewing the submission files with the country expert and engaging the global Regulatory team in resolving the technical and documentation gaps for the local registration process.
- Recommend the responses to the questions from health authorities by working with global and country Regulatory team.
- Monitor the regulatory submission, plan vs. actual; improves the internal tracking or control systems by developing workflow processes at regional level to bridge between global and local SOP and processes.
- Oversee the regulatory compliance implementation in the region and build rapport with regulatory authorities as required.
- Managing product lifecycle maintenance work in the region.
- Coordinate and provide assessment to market responses for information requests and change management assessment.
- Coordinate the field safety notification and other post-market surveillance with the country Regulatory team as directed by the legal manufacturer according to the reporting requirements of the local Authority and ensure the regulator compliance.
- Keep abreast of regulatory change and trends to ensure compliance with local regulatory requirements and advise the global RA teams on the impact.
- Support global and local initiatives and projects.
Education and Experience Requirements:
- Bachelor’s degree in biomedical engineering or equivalent field.
- Minimum of 4 years of relevant work experience in Regulatory Affairs in in-vitro diagnostic and/ or medical device industry.
- Knowledge of in vitro diagnostic and/ or medical device registration and submission process in the Asia Pacific region; China is an advantage.
- Successful experience in communicating with Regulatory Agencies.
- Understanding of ISO 13485 is advantageous.
Knowledge, Skills and Abilities:
- The job holder should show the ability to work/partner with internal stakeholders in a matrix environment and have the ability to articulate country regulatory requirements to multiple stakeholders; demonstrate the ability to identify internal & external customer’s needs and issues to recommend the realistic solutions to meet the needs of the business.
- Project Management experience demonstrating ability to successfully lead a regulatory project is a plus.
- A good command of verbal and written communication skills in English together with ability to think clearly and marshal ideas. Spoken communication must be clear and confident and must show evidence of good listening skills.
- A good team player, who can work independently.
- Travel requirement approximately 20% across APJ region.
IT Skills:
- Proficient in Microsoft Word, Excel and PowerPoint is compulsory.
Other Important Information
- Adherence to our organizational values of Integrity, Intensity, Innovation and Involvement.
At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. Apply today http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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