Assoc Dir, Regulatory AffairsReq # JR - 050968 Location Shanghai, Shanghai Municipality, China Job Category Regulatory Affairs Date posted 10/13/2021
This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.
Essential Duties and Responsibilities
- Develop and execute regulatory strategies for multiple complex programs and platforms related to local manufacturing projects as well as import drug products according to responsible therapeutic areas.
- Represent or lead team on assigned cross-functional projects.
- Responsible for regulatory intelligence; monitor applicable regulatory requirements; maintain internal related regulatory database; assure regulatory compliance with external standards, perform gap analysis and remediation plan; policy interpretations and presentations to local and global colleagues.
- Shape and develop external engagement activities with internal and external stakeholders, to build long-term and win-win relationship/partnership with external stakeholders.
- Establish appropriate communication within RA and other functions primarily at project level.
- Develop and document sound regulatory decisions and justifications for assigned projects.
- Ensure project teams and business objectives and deliverables are aligned with regulatory strategy.
- Provide direct supervision of individuals including mentoring, performance management for the subordinates.
- Bachelor’s degree or above in Pharmaceutical related discipline.
- With minimum of 8 years’ work experience, incl. at least 5 years’ experience managing people.
- At least 5 years RA experience in international pharmaceutical companies.
- Sound basis of Regulatory knowledge and Scientific Knowledge.
- Ability to manage complex projects and timelines in a matrix team environment and problem solving.
- Strong oral and written communication and presentation skills.
- Strong interpersonal skills incl. strong negotiation skills and significant experience in interacting with regulatory authorities.
- Ability to independently identify compliance risks and escalate when necessary.
- Ability to accomplish results through other.
- Ability to lead, coach, and motivate others.
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to [email protected] and let us know the nature of your request along with your contact information.
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