Manager, EU Regulatory Affairs

About AskBio

Asklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicines that can potentially cure genetic diseases has never wavered.

At AskBio, we’ve built a foundation of therapeutic programs, AAV manufacturing and a rich portfolio of patented technology. Our therapeutic focus includes neuromuscular, central nervous system, cardiovascular and metabolic diseases with clinical trials underway for Pompe disease, Parkinson’s disease, and congestive heart failure. Our gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library.

We became a wholly-owned, independently operated, subsidiary of Bayer AG in late 2020 as a cornerstone of its newly formed Cell & Gene Therapy (CGT) platform. Our global headquarters is in Research Triangle Park, NC. Additionally, we have significant operations in Philadelphia, PA, Columbus, OH, Scotland, France, and Spain.

Our vision: Pioneering science to create transformative molecular medicines.

Our mission: Lead innovative science and drive clinical outcomes to transform people’s lives.

Our principles:

• Advance innovative science by pushing boundaries.
• Bring transformative therapeutics to patients in need.
• Provide an environment for employees to reach their fullest potential.

Our values:

• Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need.
• Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view.
• Embrace Responsibility. We are humbled by the enormity of our mission. We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers.
• Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action.
• Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what’s right in every situation. Make clear commitments and follow through.

The Manager, EU Regulatory Affairs, reporting to the Senior Director, EU Regulatory Affairs, will serve as the regulatory strategy lead for AskBio’s Europe assigned projects/ products and provide leadership and direction for the pre-clinical and clinical regulatory strategies in Europe territories.

In this role, you’ll work closely with cross-functional Regulatory and Global Project Team members as well as subject matter experts to ensure that AskBio strategy align with Europe regulatory requirements and expectations. This is a Europe based remote role.

Responsibilities

• Provide regulatory guidance and interpretation to guide the product development efforts in good alignment with EU regulatory requirements and expectations.
• Serve as the regulatory point of contact with Europe health authority agencies.
• Formulate preclinical and clinical regulatory strategies for the assigned programs.
• Align and execute regulatory strategies in collaboration with management, regulatory and global project team.
• Lead the regulatory documents review, comments resolution and approval process to ensure readiness for publishing and submission.
• Lead the preparation and submission of regulatory documents in support of clinical studies (e.g., CTA/GMO), regulatory designations (e.g., PRIME) and registration (e.g., MAA).
• Write regulatory scientific advice, briefing documents, meeting request as well as review documents that are submitted to Europe’s regulatory authorities.
• Lead / Participate in regulatory agency meetings & engagement activities, provide direction to internal customers and manage external CRO interactions.
• Effectively communicate and negotiate with agencies and internal stakeholders
• Conduct regulatory due diligence for business licensing opportunities.
• Ensure regulatory compliance of all regulatory activities with applicable regulations and guidelines including the preparation and review of regulatory SOPs and regulatory quality procedures.

Required Education and Experience

• Bachelor’s Degree in a medical or biological discipline or equivalent work experience.
• 5+ years’ regulatory experience.
• Regulatory experience in Biologics.
• Experience preparing agency meeting briefing documents, regulatory designation applications, CTA or MAA submission(s) and handling EU regulatory agency interactions, both in-person and written.

Preferred Experience and Skills

• Regulatory experience in AAV based Gene Therapy.
• Experience in device and companion diagnostics.
• Ability to write, review and comment regulatory documents and resolve stakeholder differences and reach a path forward agreement.
• Proficient in MS Office products and computer applications commonly used in Regulatory Affairs.
• Experience working and effectively collaborating in a matrix work environment.
• Excellent verbal communication skills with ability to influence cross-functionally at all levels within the organization.
• Strong interpersonal communication and negotiation skills to effectively work with cross-functional stakeholders and interact with regulatory agencies.
• Strong sense of accountability, sound judgement, and attention to details.
• Demonstrated ability to effectively communicate both verbally and in writing in English.
• Excellent analytical and problem-solving skills to successfully address challenging regulatory questions and build sound regulatory narratives that are easily understood by target audience.

Asklepios BioPharmaceutical, Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job‐related requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at (919) 561-6210 or emailing us at [email protected].