Senior Director, Regulatory Affairs - Europe

Position Summary:

This role will report to the Vice President of Regulatory Affairs, Europe and is responsible for the development and implementation of global registration strategies of medicinal produces in compliance with current laws, decrees and international guidelines including subsequent life-cycle management following approval of a Marketing Authorization Application (MAA). The Senior Director, Regulatory Affairs is integral to designing and advancing the company’s effort to discover, develop and commercialize small molecule therapeutics for rare endocrine disorders and endocrine-related tumors.

Essential Job Functions and Responsibilities:

These may include but are not limited to:

• Focus on immediate and short term (2 years) strategic planning horizon
• Accountable for creation and implementation of regulatory strategy for Crinetics’ products or indications
• Provide leadership for product teams and direction to senior management on global regulatory strategy with focus on EU for all Crinetics’ drug development programs
• Articulate complex regulatory issues to project teams and external stakeholders to support global development and commercialization of drug candidates
• Accountable for management of interactions and communications with EU regulatory authorities with the goal of achieving company objectives
• Develop and submit regulatory dossier (including responses, briefing packages, MAA’s, or other regulatory dossiers)
• Define and implement strategies and objectives for as well as author, review, and/or edit regulatory documents and presentations, as necessary
• Responsible for strategic planning and preparation for meetings and follow-up with the regulatory authorities including defining goals and desired outcomes for interactions as well as preparation of meeting agenda, briefing packages and meeting minutes. Develop regulatory program timelines
• Contribute to the monitoring, communication and management of regulatory budgets
• Set clear outcomes/deliverables for projects and own them, staying accountable to the company management team
• Develop relationships with external parties (e.g., health authorities, CROs, consultants,) and stay current on industry trends and practices
• Set high standards on deliverables while managing risks and timelines
• Manage and provide guidance/training for regulatory staff members. Provide regular feedback and coaching for their professional development
• Ensure compliance with appropriate RA SOPs and working instructions
• Develop and oversee department policies and procedures to achieve department and corporate goals
• Prepare periodic status reports
• Collaborate with cross-functional teams and global regulatory counterparts
• Other duties as assigned

Product Development and Product Lifecycle Management:

• Act as contact person for selected regulatory health authorities (e.g. EMA and MHRA) and manage regulatory interactions and negotiations
• Formulate regulatory submission strategies and operations
• Ensure timely and correct submission of registration applications in alignment with the company strategic goals
• Ensure regulatory submission strategies for geographical expansion
• Write, review and approved relevant documentation e.g. briefing books for scientific advice in collaborations with cross-functional project teams
• Regulatory life-cycle management for licensed products (e.g. preparations, coordination of submission of variations, annual reports, post-authorization measures)
• Provide in-depth knowledge of applicable regulatory affairs laws, regulations and policies, important evolving guidelines both national and internationally
• Regulatory approval of labeling for marketed products

Education and Experience:

Required:

• University degree (MSc) in life-science (pharmacy, molecular biology, regulatory affairs and/or PhD
• 13+ years’ experience in the development of human medicines in a pharmaceutical or biotechnology company, at least 7-10 years in Regulatory Affairs and a minimum of 10 years in a supervisory role
• Proven track-record of a successful submission of a MAA in Europe and/or other ICH regions
• Advanced knowledge of regulatory submission and approval process
• Proved direct interactions with health authorities (e.g. scientific advice, primary contact person)
• Excellent written and verbal communication skills
• Decision making ability
• Knowledge of regulatory intelligence sources to provide accurate regulatory advice
• Advanced experience with orphan medicinal products and pediatric investigation plans

Preferred:

• Business degree beneficial
• Rare disease experience strongly preferred
• A combination of small/start-up company experience as well as working at established biopharmaceutical companies.
• Experience launching a new product to market is highly desired
• Experience working with Development, Sales, Marketing, Commercial Operations, Market Access, Medical Affairs, and other cross-functional teams to achieve shared goals and objectives

Travel:

You may be required to travel for up to 25% of your time.