Reg Affairs Associate/director

3 weeks ago

Johor, Malaysia Thermo Fisher Scientific Full time

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.

Our Regulatory Affairs Department is looking for a Regulatory Affairs Lead (Client Dedicated) for a key strategic partner of CRG.

This is an exciting opportunity to have a key role for coordinating activities between the Client based in Europe and their key Partner in China. You would have responsibility to oversee and manage the pre
- and post-approval activities and processes with the Partner and ensure coordination with the Client in meeting their global business objectives. An excellent knowledge of Chinese culture and language will be essential for this role with the opportunity to travel between Europe and China.

Major responsibilities:

- Focused on the interactions of our Client based in Europe and key Partner in China
- Coordinate (pre
- and post-approval) activities for their product in China liaising closely with the Partner
- Partnering / validating / overseeing Partner activities in China and manage in relation to the Client’s overall business objectives
- Provide regulatory consulting and strategic advice the client to determine the most appropriate regulatory and product development strategy for their products in relation to their activities in China. Provide project specific strategy, technical expertise and coordination oversight for client.
- Serves as the contact for client, including attendance at regulatory authority meetings
- Ensure quality performance for key/managed projects.
- Contributes to development and implementation of global/regional function/plans for the client.

Education, Experience and Qualifications:

- 5-8 years of regulatory affairs experience within biopharmaceutical organizations, of which at least 5-7 years focus on China
- PhD or PharmD preferred
- Experience interacting with regulatory authorities in China
- High level of Post-approval and development knowledge
- Strong knowledge of Chinese culture
- Fluency in English and Mandarin
- Ability to travel to China
- Demonstrated ability to coordinate the development of strategies and regulatory submissions involved in the approval of medicines with a focus on the China
- Track record of successful interactions with regulatory and health authorities

**What we offer**:
At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award-winning learning and development programme, ensuring you reach your potential.

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD clinical research services truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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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