This role involves leading proactive monitoring and surveillance on changes in the global regulatory landscape focused on drug development lifecycle starting from preclinical through commercialization. The position will oversee and support daily operations and governance, ensuring that all processes and activities related to surveillance and assessment are conducted efficiently and effectively. This is a 7 month contract role.
JOB RESPONSIBILITIES:
1. Monitor and analyze the external regulatory environment, including guidelines and regulations from regulatory authorities, trade organizations, working groups, and relevant industry thought leaders.
2. Lead the comprehensive day-to-day oversight and management of Reg Intel Systems and Dashboards – Ensure seamless operation, maintenance, and continuous improvement of these tools, which are needed for monitoring and analyzing regulatory trends and compliance requirements.
3. Work closely with cross-functional teams, including IT, GDS, compliance, regulatory affairs and other functions as well as external vendors to ensure that the Reg Intel Systems and dashboards are aligned with organizational goals and regulatory requirements.
4. Identify business critical aspects and communicate effectively to internal stakeholders.
5. Collaborate with cross-functional teams to align regulatory intelligence with business objectives.
6. Lead cross-functional teams to streamline Regulatory Intelligence-related processes and improve operational efficiency.
7. Stay abreast of the latest technological advancements and regulatory changes. Proactively seek out and implement innovative solutions to enhance the functionality and effectiveness of the Reg Intel Systems and dashboards.
8. Implement best practices and innovative solutions to enhance regulatory compliance and efficiency.
9. Conduct regular reviews and assessments to ensure continuous improvement in regulatory processes.
10. Provide ongoing support and training to users of the Reg Intel Systems and dashboards. Develop comprehensive training materials and conduct workshops to ensure that all users are proficient in utilizing these tools to their full potential.
11. Support project teams, functions and departments through the collection and distribution of requested regulatory intelligence information.
JOB REQUIREMENTS:
1. Education: Minimum Bachelor’s Degree in Sciences, Engineering or other similar discipline.
2. Project Management/Six Sigma certification a plus.
3. Experience: Minimum 5-6 years of experience in the biotech/pharmaceutical industry or Health Authority experience (with a focus in Regulatory, Drug Safety and/or Clinical preferred).
4. Good understanding of the drug development and commercialization processes, as well major Health Authority regulations governing these processes (such as FDA, EMA, Health Canada, PMDA etc.).
5. Proficiency in regulatory intelligence tools and systems, with the ability to implement and optimize these technologies.
6. Strong analytical skills with the ability to interpret complex regulatory information and provide actionable insights.
7. Strong project management skills, including the ability to manage multiple projects simultaneously and meet deadlines.
8. Strong problem-solving skills with the ability to make informed decisions based on regulatory intelligence and data analysis.
9. Excellent written and verbal communication skills, with the ability to effectively communicate complex regulatory information to diverse audiences.
10. Demonstrated leadership skills with experience in managing and mentoring a team of regulatory professionals.
11. High level of attention to detail and accuracy in regulatory documentation and reporting.
12. Ability to adapt to changing regulatory landscapes and organizational priorities.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way!
We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.
The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
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