Sr Manager, Global Regulatory Affairs Cmc

About Freyr

Freyr is a global Regulatory Affairs and Life Sciences consulting organization supporting pharmaceutical, biotechnology, medical device, and healthcare companies across the product lifecycle. Our teams bring deep regulatory, scientific, and operational expertise to help clients navigate complex global requirements and deliver high-quality outcomes.

Job Title: Sr Manager, Global Regulatory Affairs Strategist CMC

Job Type: Permanent

Job Location: Princeton NJ, - Remote

Job Description:

Key Responsibilities

• Define, coordinate, and implement global CMC regulatory strategies for product-specific development and lifecycle activities.
• Provide proactive strategic guidance to product-specific global regulatory and manufacturing sub-teams for defining global regulatory CMC strategies and objectives throughout development, regulatory commercialization, and lifecycle management of drug products in the United States and international markets.
• Liaise directly with the FDA and local regulatory teams for discussions with international Health Authorities and agencies regarding CMC-related matters.
• Manage CMC regulatory strategy for high-quality and compliant regulatory CMC documentation, including BLAs, INDs, CTAs, MAAs, variations/supplements, and other relevant regulatory filings.
• Advise on regulatory strategies and solutions to scientific problems and interpretation of results in the context of product registration requirements combined with business needs and goals.
• Facilitate communication and flow of regulatory information, including regulatory framework, scope, and project timelines, to relevant stakeholders.
• Identify and resolve most effective CMC regulatory strategies to assure first-pass regulatory approval of initial applications and lifecycle supplements/variations.
• Contribute to the development and implementation of innovative CMC regulatory strategies in collaboration with relevant stakeholders and functions.
• Provide proactive guidance and regulatory strategies to support PDT product teams.
• Interface with key Global Regulatory Affairs CMC and PDT R&D functions in the preparation, review, and approval of regulatory CMC submissions.
• Develop and manage timelines supporting regulatory submissions and proactively identify risks and develop appropriate risk-management solutions in consultation with cross-functional teams.
• Evaluate CMC change controls and ensure regulatory requirements are fully assessed and implemented.
• Provide tactical and strategic regulatory input and guidance, including participation in problem-solving analysis and evaluation of alternative solutions.
• Maintain an ongoing and interactive relationship with regional and local regulatory teams to ensure regulatory activities are conducted in full compliance with applicable regulations and at the highest level of ethical standards.
• Create high-quality, compliant regulatory CMC documents within defined timelines.
• Participate in discussions and negotiations with regulatory authorities, agents, business partners, and other stakeholders as required.
• Assist in the conduct of regulatory agency inspections and compliance audits.

Qualifications and Experience

• Bachelor's degree in a scientific discipline;
  advanced degree preferred.
• 6+ years of biotechnology/pharmaceutical industry experience.
• 4+ years of regulatory CMC experience, with biologics or plasma-derived products preferred.
• Extensive experience in global pharmaceutical/biotechnological drug development and a proven knowledge of the global regulatory CMC environment.
• Demonstrated experience in authoring and managing components of regulatory submissions.
• Strong knowledge of global regulatory requirements and demonstrated ability to function as the lead interface with the FDA.
• Ability to support regional and local regulatory affairs teams in interactions with regional or local Health Authorities, including EMA, PEI, AGES, PMDA, and Health Canada.
• Demonstrated ability to develop and implement global CMC regulatory strategies, resolve complex issues, and negotiate optimal regulatory pathways and outcomes with Health Authorities.
• Ability to use precedent and previous experience to develop innovative and flexible approaches to achieve development and commercial goals.
• Extensive experience in US and/or International Regulatory Affairs, including experience with INDs, BLAs/NDAs, MAAs, drug development, and/or expedited regulatory pathways.
• Strong oral and written communication and negotiation skills.
• Ability to collaborate effectively with teams and key cross-functional areas.
• Strong understanding of global regulatory CMC requirements and Health Authority interactions and negotiations.
• Highest level of compliance integrity and business adaptability.

Leadership & Stakeholder Management

• Demonstrate strategic enterprise thinking and identify innovative ways to serve patients and build trust, reputation, and business.
• Create an environment that inspires and enables people to move the organization forward.
• Focus on key priorities and deliver superior results.
• Elevate organizational capabilities for the present and future.
• Motivate, mentor, and manage diverse teams in a matrix environment.
• Provide strategic vision, leadership, management, and oversight in defining proactive global CMC regulatory strategies.
• Demonstrate a global perspective and ability to work across functions, regions, and cultures.
• Identify potential challenges and opportunities and make recommendations and decisions.
• Collaborate effectively and establish credibility and confidence within and outside the organization.
• Build and maintain strong cross-functional stakeholder relationships.
• Demonstrate agile leadership by seeking to understand and evolving ideas as needed.

Decision-Making & Autonomy

• Act decisively and exercise sound judgment when working with limited information.
• Develop clear business arguments and strategic recommendations using quantitative and qualitative evidence.
• Seek diverse input while balancing multiple internal and external stakeholders to drive solutions and establish priorities.
• Incorporate feedback and ensure decisions are made quickly to enable effective execution.
• Develop executable plans and meet deadlines.
• Apply a data-driven approach to decision-making.
• Challenge existing approaches to overcome regulatory barriers and deliver high-quality solutions.
• Negotiate and influence without authority in a matrix environment.
• Demonstrate clear decision-making following appropriate consultation, including in situations of ambiguity.

Interaction

• Demonstrate organizational awareness and leverage internal networks to enable alignment and effective execution.
• Recognize the importance of stakeholder connections and bring appropriate stakeholders together to develop effective solutions.
• Demonstrate exceptional communication, negotiation, presentation, and influencing skills across internal and external stakeholders.
• Build effective relationships across global, regional, and local regulatory teams.

Innovation

• Continuously challenge the status quo and bring forward innovative solutions.
• Identify opportunities for process and systems innovation.
• Implement changes that enhance the overall effectiveness of the team.
• Develop innovative and flexible regulatory approaches to support development and commercial objectives.

Complexity

• Deliver solutions to abstract problems across functional areas of the business.
• Identify and solve fundamental issues through assessment of intangible variables.
• Recommend key decisions, escalate key issues through appropriate governance frameworks, and influence key stakeholders.
• Create clarity of accountabilities within a global and highly matrixed organization.
• Provide information and recommendations that resolve or simplify complexity across commercial, operational, and strategic considerations.
• Work effectively through large-scale global change management.

Core Skills

• Global Regulatory CMC Strategy
• Regulatory CMC Submissions
• CMC Regulatory Strategy for Biologics
• Plasma-Derived Therapies (PDT)
• IND / BLA / MAA Submissions
• Regulatory CMC Submission Authoring
• CMC Dossier Management
• Global CMC Regulatory Requirements
• FDA / EMA / PMDA / Health Canada Interactions
• Health Authority CMC Negotiations
• CMC Lifecycle Management
• CMC Change Control & Regulatory Assessment
• Global CMC Regulatory Pathways
• Regulatory CMC Risk Assessment
• Biologics Regulatory Affairs
• Regulatory Risk Management
• Ability to Influence Without Authority

What We Offer

• Opportunity to work on complex global Regulatory Affairs and CMC programs.
• Exposure to global pharmaceutical and biotechnology regulatory environments.
• Collaboration with experienced regulatory and life sciences professionals.
• Opportunities for professional development and career growth.
• A global and cross-functional working environment.
• Opportunity to contribute to innovative regulatory strategies supporting product development and commercialization.

Why Join Freyr

• Be part of a global Life Sciences and Regulatory Solutions organization.
• Work on challenging regulatory programs across pharmaceutical and biotechnology organizations.
• Gain exposure to global regulatory strategies, CMC submissions, and Health Authority interactions.
• Work with multidisciplinary teams across regulatory, scientific, and business functions.
• Build expertise across global regulatory markets and product lifecycle activities.
• Grow your career in a collaborative and innovation-driven environment.

Equal Opportunity Employer

Freyr is committed to providing equal employment opportunities and fostering an inclusive workplace where diverse perspectives are valued. We provide opportunities based on qualifications, experience, skills, and business requirements.