Senior Manager Regulatory Intelligence

Regeneron Pharmaceuticals; Uxbridge; On-site; GBP 50,000 - 70,000; Full time

Job summary

A leading biotechnology company in the UK is seeking a Manager, Regulatory Intelligence (Contractor) to oversee the regulatory landscape and ensure the efficiency of processes. Key responsibilities include monitoring regulations, managing regulatory intelligence systems, and collaborating with cross-functional teams. Candidates should have a Bachelor’s degree in sciences or engineering and 5-6 years of relevant experience. Excellent communication and leadership skills are essential, along with a solid understanding of the drug development process.

Benefits

Comprehensive benefits

Inclusive culture

Training and development opportunities

Qualifications

• 5-6 years of experience in the biotech/pharmaceutical industry.
• Experience with Health Authority regulations is preferred.
• Focus on Regulatory, Drug Safety, or Clinical.

Responsibilities

• Monitor and analyze the external regulatory environment.
• Lead oversight of Regulatory Intelligence Systems.
• Collaborate with cross-functional teams to align regulatory goals.
• Identify business-critical aspects and communicate effectively.
• Stay updated on technological advancements and regulatory changes.
• Conduct reviews for continuous improvement in regulatory processes.
• Provide support and training for regulatory systems users.

Skills

Understanding of drug development

Proficiency in regulatory intelligence tools

Analytical skills

Project management

Excellent communication skills

Leadership

Detail-oriented

Adaptability

Education

Bachelor's Degree in Sciences, Engineering, or similar

Project Management/Six Sigma certification

Job description

We are Regeneron, a leading biotechnology company dedicated to improving lives through innovative drug development. We are seeking a Manager, Regulatory Intelligence (Contractor) to join our Regulatory Affairs Strategy & Intelligence team. This role is pivotal in supervising and analyzing the global regulatory landscape, ensuring our processes and activities are efficient and effective.

A Typical Day:

• Monitor and analyze the external regulatory environment, including guidelines and regulations from regulatory authorities, trade organizations, and industry thought leaders.
• Lead the comprehensive day-to-day oversight and management of Reg Intel Systems and Dashboards, ensuring seamless operation, maintenance, and continuous improvement.
• Collaborate with cross-functional teams, including IT, GDS, compliance, regulatory affairs, and external vendors to align Reg Intel Systems with organizational goals and regulatory requirements.
• Identify business-critical aspects and communicate effectively to internal stakeholders.
• Stay abreast of the latest technological advancements and regulatory changes, proactively seeking and implementing innovative solutions.
• Conduct regular reviews and assessments to ensure continuous improvement in regulatory processes.
• Provide ongoing support and training to users of the Reg Intel Systems and dashboards, developing comprehensive training materials and conducting workshops.

This Role May Be For You:

• You have a strong understanding of the drug development and commercialization processes, as well as major Health Authority regulations (e.g., FDA, EMA, Health Canada, PMDA).
• You are proficient in regulatory intelligence tools and systems, with the ability to implement and optimize these technologies.
• You possess strong analytical skills, capable of interpreting complex regulatory information and providing actionable insights.
• You excel in project management, able to manage projects simultaneously and meet deadlines.
• You have excellent written and verbal communication skills, optimally conveying complex regulatory information to diverse audiences.
• You demonstrate leadership skills, with experience in managing and mentoring a team of regulatory professionals.
• You are detail-oriented and accurate in regulatory documentation and reporting.
• You can adapt to changing regulatory landscapes and organizational priorities.

To Be Considered:

You must have a minimum of a Bachelor’s Degree in Sciences, Engineering, or a similar discipline. Project Management/Six Sigma certification is a plus. You should have 5-6 years of experience in the biotech/pharmaceutical industry or Health Authority experience, with a focus on Regulatory, Drug Safety, and/or Clinical preferred.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.

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.