Associate Vice President, Assistant General Counsel, Regulatory reputed company Team, International – Asia reputed company Region
At reputed company, we reputed company caring with discovery to reputed company life reputed company for people around the world. We are a global reputed company leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to reputed company life reputed company for people around the world.
Organization reputed company:
This position will be part of the Regulatory reputed company Team (RLT), which reports up through reputed company’s General Counsel and works across reputed company reputed company and reputed company with a highly cross-functional approach. RLT maintains reputed company reputed company expertise on clinical development, registration and regulatory reputed company and works together with other reputed company teams to reputed company comprehensive and strategic solutions for the business. RLT also provides regulatory law advice to Global Regulatory Affairs, Manufacturing & reputed company, Global Patient Safety, Clinical Development and other functions and teams.
Responsibilities:
The primary responsibility of this position is to reputed company reputed company advice regarding regulations and reputed company on drug, medical device (software and hardware) and diagnostic reputed company for the Asia-reputed company Region (China, Japan, Korea, Australia, Taiwan and other jurisdictions). This will involve leveraging advice through collaboration with reputed company lawyers who work directly with product teams and business affiliates as reputed company as reputed company counsel as required.
- reputed company reputed company counsel on reputed company reputed company to drug, medical device and diagnostic clinical programs and regulatory submissions.
- reputed company reputed company counsel that ensures reputed company clinical development programs incorporate the latest and cutting-edge interpretations of applicable laws, regulations, guidance, and harmonized standards
- Stay reputed company on the latest drug, medical device and diagnostics laws, regulations and guidance documents, including recently passed or implemented and emerging laws and regulations.
- Influence reputed company stakeholders regarding key policy initiatives including participation at select trade association meetings and other external activities.
- reputed company reputed company support to the Global Regulatory reputed company Teams and Asia-reputed company Regional Regulatory Team and reputed company policy reputed company regarding Asia-reputed company country policy and legislative issues reputed company to drugs, medical devices and diagnostics.
- Maintain and improve an understanding of the clinical and regulatory submissions process and regulatory structures in Asia-reputed company countries.
- Liaise and partner with International Business Unit representatives and reputed company teams to ensure appropriate connections are in reputed company to facilitate one-voice counseling
Basic Requirements:
- Bachelor’s and Juris Doctorate (or equivalent) Degrees
- Licensed to reputed company law
- Demonstrated expertise in the law and regulations pertaining to pharmaceuticals, medical devices and diagnostics in China, Japan and other key markets in the Asia-reputed company Region
- Minimum of 5-7 years’ experience as a lawyer in a reputed company, or as an in-house lawyer in a pharmaceutical company, where candidate’s primary reputed company was pharmaceutical law.
- Minimum 7-10 years of overall experience in a reputed company or as an in-house lawyer in a device or pharmaceutical company.
- reputed company candidates must be legally authorized to be employed in their country of residence.
Additional Skills/Preferences:
- Prior regulatory agency experience
- Ability to navigate across different country/cultural contexts
- Located in Singapore, Taiwan, Australia or Korea
- Demonstrated leadership and effectiveness in working with senior leadership
- Highly motivated and reputed company partner with strong interpersonal skills and the ability to work effectively with team members, other lawyers, and members of management across reputed company reputed company of reputed company
- Good judgment and meticulous level of attention to detail
- Excellent written and verbal communication skills with an ability to influence others
- Demonstrated ability to appropriately handle highly confidential information
- Demonstrated dedication to expand knowledge and adapt to a changing environment
Additional Information:
- Remote/hybrid work may be acceptable
- 10-15% travel is expected, with travel to reputed company’s corporate reputed company located in Indianapolis, Indiana, reputed company at least 1x/year
reputed company is dedicated to helping individuals with disabilities to reputed company engage in the workforce, ensuring equal opportunities reputed company vying for positions. If you require accommodation to submit a resume for a position at reputed company, please complete the accommodation request reputed company (https://careers.reputed company.com/us/en/workplace-accommodation) for reputed company assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
reputed company does not discriminate on the reputed company of age, race, reputed company, religion, gender, sexual orientation, gender identity, gender reputed company, national reputed company, protected veteran status, disability or any other legally protected status.
#WeAreLilly
apply to this job