Manager, Regional Regulatory Lead - LCM

Location: Hybrid position based in Waltham, Massachusetts, or King of Prussia, Pennsylvania, with a minimum of 3 days onsite each week. Relocation and mobility assistance are not provided.

Salary: $129,000–$153,000 per year, plus potential incentive compensation and equity.

Company

hirify.global Behring is a global biotherapeutics company developing and delivering therapies across immunology, hematology, cardiovascular and metabolic, respiratory, transplant, vaccine, iron deficiency, and nephrology areas.

What you will do

• Develop and execute regional regulatory strategies for assigned pharmaceutical and biological products.
• Manage relationships and interactions with health authorities, including the FDA or EMA, and support negotiations for regulatory outcomes.
• Contribute to regulatory submissions, core documents, pediatric plans, filing preparation, Module 1 documentation, and responses to health authority comments.
• Provide guidance on regulatory requirements, filing pathways, project risks, and opportunities for developmental, new, and marketed products.
• Partner with Global Regulatory Affairs Strategy Team members, Regulatory CMC, regional commercial stakeholders, and product Global Regulatory Leads.
• Maintain regulatory systems such as Veeva and ensure timely tracking and compliance deliverables.

Requirements

• Bachelor’s degree in Pharmacy, Biology, Chemistry, Pharmacology, Clinical Medicine, or a related life science field.
• 5+ years of regulatory or submission experience in the biotech or pharmaceutical industry.
• 3+ years of experience working with developmental products.
• Knowledge of pharmaceutical or biological product development and regulatory approval requirements in one or more key regions, including the EU, US, or Japan.
• Experience in complex, matrixed environments, with strong strategic thinking, risk assessment, communication, and relationship-building skills.
• Ability to work onsite at the designated US location at least 3 days per week.

Nice to have

• Advanced degree such as MS, PhD, MD, DVM, or MBA.
• Regulatory Affairs experience with direct agency interaction responsibility.
• Clinical or medical device background.

Culture & Benefits

• Project-led R&D environment focused on collaboration and innovation.
• Work supporting therapies for patients with serious and chronic conditions.
• Inclusive culture centered on belonging, curiosity, empathy, and diverse perspectives.
• Potential incentive compensation and equity in addition to base salary.