Sr. Manager, Regulatory Information Management

About This Role

Are you passionate about regulatory systems and business process excellence? As the RIM Senior Manager, you'll be at the heart of our global Regulatory Information Management team. You'll partner with business process owners and IT to ensure our RIM systems are accurately evaluated, documented, and maintained in a compliant state. This role is pivotal in enabling seamless business systems operations, supporting global users daily, and driving the success of our regulatory ecosystem. You'll report to senior leadership and play a key role in shaping the future of regulatory information management within our organization.

What You'll Do

• Serve as the business system owner for one or more primary RIM capabilities
• Partner with IT and business functions to deliver on the RIM roadmap
• Lead and support system upgrade activities, ensuring compliance and operational excellence
• Maintain and optimize RIM systems and related processes
• Provide direct daily support to global users of regulatory systems
• Lead smaller projects focused on data curation across multiple disciplines and processes
• Collaborate with cross-functional teams to drive improvements and resolve issues
• Document and communicate system changes and project outcomes
• Ensure regulatory requirements are met in all system operations

Who You Are

You thrive in a collaborative, fast-paced environment and have a deep understanding of regulatory systems. You're a proactive problem solver, skilled at partnering across functions and driving projects to completion.

Required Skills

• 8+ years of experience 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.
• 5+ years experience in Regulatory Information Management (RIM), Regulatory EDMS capabilities, or operations in a similar capability model in GxP/Regulated Systems
• Subject matter expertise within applicable Regulatory Agency regulations, guidelines, and specifications (e.g. FDA/EMA, ICH, eCTD, IDMP) and industry best practices pertaining to Regulatory Processes & Systems. Direct IDMP experience is highly preferred.
• Familiarity with MDM & enterprise reporting capabilities a plus (e.g. Tableau, etc.)

Preferred Skills

• Experience with data curation projects
• Familiarity with global regulatory environments
• Project Management skills and competencies

Additional Information

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

Why Biogen?

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 onto 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.