Executive Director of Regulatory Affairs

The Executive Director of Regulatory Affairs is responsible for providing regulatory leadership, for planning and oversight of all regulatory submissions from pre-submission to approval of marketing authorizations. This position will provide the regulatory and technical expertise into the Company's development plans of its product candidates (CNM-Au8, CNM-ZnAg), including the development of regulatory strategies to support clinical trial application and marketing approvals in the US and internationally, maintain compliance with applicable regulatory requirements, provide expert regulatory opinion to ensures alignment of global regulatory strategies, and provide support for life cycle management. They will drive NDA preparations, manage health authority interactions and advise teams on asset strategy, indication strategy, clinical study designs and regulatory plans. Responsible for addressing data requirements to regulatory authorities. Prepares for and expedites early and effective approval of pharmaceutical new products in accordance with regulatory strategy, develops, and implements acceleration strategies. Proactively anticipates and mitigates regulatory risks. They will work cross-functionally with R&D, Quality, supply chain, compliance, legal, operations, marketing and other departments.
Responsibilities:

· Accountable for developing and implementing innovative global regulatory strategies to maximize the likelihood of regulatory success including submission strategy and implementation of major regulatory dossiers.

· Accountable for developing a regulatory team to plan, develop, and review submissions to regulatory authorities including FDA, EMA, and other global health authorities to support the conduct of clinical trials and approval of marketing applications (including but not limited to Investigational New Drug (IND), Clinical Trial Authorization (CTA), New Drug Application (NDA), and Marketing Authorization Application (MAA).

· Accountable for the development and maintenance of submission timelines and work with cross-functional teams to support planned company and regulatory objectives.

· Interprets and applies regulations in the creation of timely and innovative regulatory strategies for US and international markets.

· Serves as the primary point of contact with Regulatory Authorities and represents the regulatory interests of the Company.

· Interacts with regulatory agencies, coordinating the preparation and supporting documentation as well as leading meetings and other interactions; maintains correspondence and other records of regulatory interactions.

· Develops strong working relationships with counterparts of FDA, EMA, and other regulatory authorities.

· Accountable for conducting regulatory risk planning and mitigation to minimize regulatory issues and helps prevent unnecessary regulatory delays

· Participates in key interactions with health authorities and communicates health authority feedback to drug discovery and clinical development teams.

· Oversees development and maintenance of internal Global Regulatory Affairs practices and procedures.

· Remains up to date on the global regulatory environment, regulations, and guidance.

· Maintains knowledge of the Company’s targeted disease areas through regulatory intelligence and KOL interactions.

· Trains staff in the preparation of documentation for regulatory review in technical areas, and performs regular evaluation

· Ensure compliance of Company SOPs, protocols, and specifications in order to codify procedures to be used as a reference among Company employees and contractors

· Performs record review to assure quality submission of regulatory documents.

· Participates in due diligence activities and alliance management for partnered programs, as applicable.

· Represents the regulatory function on cross-functional development teams.

· Provides information to support planning and maintenance of the regulatory budget.

Qualifications You Bring:

· Advanced degree in a life science required (e.g., PhD, PharmD, or master’s degree).

· Preferred Education: Relevant graduate degree preferred. Certifications a plus

· 10+ years in Regulatory Affairs with prior leadership experience in Regulatory Affairs required.

o Some portion may include experience related to pharmaceutical regulatory work (e.g., other R&D role or specialized training). R

o Requires drug development experience in US region with 10+ years in pharmaceutical, R&D or related industry experience.

o An equivalent combination of relevant education and applicable job experience may be considered.

· Proven 5+ years in a leadership role with strong management skills, demonstrated executive presence. Experience working in a complex and matrix environment with multiple stakeholders, and on cross-functional teams.

· Significant e`xperience bringing pharmaceutical products through development review and approval. Broad experience contributing to enterprise management of a portfolio of products. Strong verbal and written communicator with strong negotiation skills and strategic thinking. Strong business acumen and the ability to work under pressure.

Must Possess

• Thorough knowledge of US and international regulations as they apply to pharmaceutical and biologic drug development.
• Previous experience managing development of INDs and other global clinical trial applications, experience developing and implementing successful global regulatory strategies, and experience interfacing with government regulatory agencies.
• Experience managing development of NDAs/MAAs as well as considerable experience leading regulatory agency interactions, meetings (including Advisory Committees or Scientific Advice procedures).
• Full lifecycle experience from early development to managing marketed products, preferably neurology focused.
• Ability to work in a cross-functional team environment and a flexible team-oriented perspective
• Excellent verbal and written communication skills as well as interpersonal, management, and organizational skills
• Skilled at negotiating with business partners or management and influencing senior-level leaders regarding matters of significance to the organization
• Proficient at creating and communicating a clear vision among team members effectively aligning resources and activities to achieve functional area and/or organizational goals