Manager, Regulatory Information Management

About This Role
Are you passionate about driving compliance and operational excellence in a dynamic, global environment? We’re seeking a Regulatory Information Management (RIM) Manager to join our team and play a pivotal role in shaping the future of our regulatory systems.

As our RIM Manager, you’ll be at the heart of our Regulatory Information Management Systems, partnering closely with business process owners and IT to ensure every system upgrade is evaluated and documented with precision. You’ll help maintain our systems and processes in a compliant state, supporting global users and empowering them to leverage regulatory systems effectively.

You’ll serve as the business system owner for key capabilities within the RIM Ecosystem, collaborating with IT and cross-functional teams to deliver on our ambitious RIM roadmap. Your leadership will extend to smaller, high-impact projects focused on data curation, influencing multiple disciplines and processes across the organization.

What You’ll Do
Advise on centralized regulatory business systems operations, including monitoring and assurance of data standards

Support centralized data services within RIM capabilities and enterprise resource management

Provide data reporting, analysis, and interpretation for the Regulatory department

Serve as RIM Application SME for Regulatory-IT capability projects; participate in multiple workstreams and may lead mid-size programs

Own one or more RIM systems and support the RIM roadmap

Collaborate with functional SMEs (e.g., GSRS, Emerging Markets, Submission Sciences) and partner lines (e.g., RegCMC, IT) to understand business needs for new or modified solutions

Document business requirements for regulatory solutions, ensuring stakeholder endorsement and alignment; partner with IT for execution and delivery

Engage with industry associations and contribute to intelligence/policy initiatives, aligning with internal and external stakeholders and focusing on organizational interests

Who You Are
The ideal candidate is a collaborative problem-solver with a strong understanding of regulatory systems and data management. They excel at partnering across business and IT functions, thrive in dynamic environments, and are passionate about driving compliance and operational excellence. Adaptable and detail-oriented, they communicate effectively with global stakeholders and proactively lead projects that enhance regulatory processes.

Why Biogen?
Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

Required Skills
5+ years of experience in Pharmaceutical, Bio-Technology, or Life Sciences, with a specific focus in Regulatory of at least 5+ years and working knowledge of Biopharma drug development and approval process.

3+ years experience in Regulatory Information Management (RIM), Regulatory EDMS capabilities, or operations in a similar capability model in GxP/Regulated Systems

Working knowledge of applicable Regulatory Agency regulations, guidelines, and specifications (e.g. FDA/EMA, ICH, eCTD, IDMP) and industry best practices pertaining to Regulatory Processes & Systems

Preferred Skills
Regulatory operations experience; submissions publishing a plus.

Extensive experience with Regulatory Information Management systems (e.g., InSight RIM, Veeva RIM, etc).

Compensation and Benefits
Job Level: Management

The base compensation range for this role is: $110,000.00–$148,000.00

Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.

In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:

Medical, Dental, Vision, & Life insurances

Fitness & Wellness programs including a fitness reimbursement

Short- and Long-Term Disability insurance

A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26–Dec 31)

Up to 12 company paid holidays + 3 paid days off for Personal Significance

80 hours of sick time per calendar year

Paid Maternity and Parental Leave benefit

401(k) program participation with company matched contributions

Employee stock purchase plan

Tuition reimbursement of up to $10,000 per calendar year

Employee Resource Groups participation

Commitment to Inclusion and Excellence
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.

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