Executive Director, Regulatory Affairs International
Employment Type: Full Time
Reference Number: 2538936
Job Description Summary
Reporting to the SVP and Head of International, based in Zug, and the VP Regulatory Affairs & Quality, based in San Diego, this professional will be part of both the International Leadership and the Global Regulatory Affairs Teams with responsibility for oversight of EU and International Regulatory activities to support corporate business goals. Proactively providing regulatory guidance, developing and implementing strategies to efficiently advance pipeline compounds through to commercialization and compliant post approval lifecycle management.
Collaborates closely with cross‐functional teams to ensure effective regional as well as affiliate regulatory support. Participates in senior level interactions with external partner companies, Contract Research Organization (CRO) regulatory personnel, and external vendors. Functions as primary senior regulatory representative interacting with EMA and affiliated region regulatory agencies. Helps evaluate business impact of changes in government regulatory requirements and policies and develops responses. Helps develop infrastructure and process improvements, including implementation of applicable e‐tools, to enhance the efficiency of the Regulatory Affairs Department operations. Participates in the selection and development of personnel to ensure enhancement of Regulatory Affairs function.
- Responsible for managing and leading multi-disciplinary teams and/or Contract Service Providers, to achieve project and business goals per timelines
- Provides effective regulatory guidance to the company's research and development organization, helps identify regulatory risks and resolutions, and develops effective regulatory strategies to help efficiently advance lead product candidates
- As the Marketing Authorisation Holder representative, leads the development and reviews EU centric regulatory submissions (eg. MAA, variations, post marketing measures, PIP documents), to ensure high quality standards and regulatory requirements are met, in line with corporate objectives
- Ensures regulatory agency questions during MAA and variation reviews are responded to promptly and comprehensively to resolve issues and obtain timely regulatory approvals. Functions as senior primary regulatory representative for negotiations with EMA/MHRA and other international regulatory agencies
- Ensures coordination of Regulatory Affairs activities both at the International regional as well as local country level.
- Assesses country and regional‐specific regulations/requirements, and develops proactive regulatory plans and strategies, aligned with business goals, to expedited development of the company's proprietary products towards commercialization
- Participates in senior level interactions with external business partners to provide regulatory expertise on co‐development of products
- Oversight responsibility to help ensure compliance with EMA /MHRA/ International government regulatory requirements, International Conference on Harmonization (ICH) standards and relevant regional and/or local Codes of Conduct
- Keeps current on US and International regulatory developments and changes in government policies/ requirements to advise on impact on company projects/business and to develop appropriate response plans
- Oversight responsibility for resolving issues with regulatory impact resulting from audits of external vendors/CROs and health authority inspections.
- Helps develop the infrastructure of the Regulatory Affairs Department, including SOPs and implementation of process improvements, to enhance the efficiency of operations
- Helps manage budget and provides input into budgeting and resource requirements
- Helps select CRO regulatory consultants/personnel and manages their activities to ensure deadlines and milestones on company regulatory projects are achieved per deadlines to meet company goals
- Participates in the selection, development, management, and performance review of personnel to enhance the Regulatory Affairs functional operations
What is Required
- Demonstrated experience and ability to successfully interact and negotiate with senior EMA/ MHRA/ International Agency regulatory reviewers, and external vendors partners
- Broad experience in Regulatory disciplines (i.e., clinical, labeling, safety & CMC, ) is preferred
- Expert knowledge in EU/International regulations and guidance Up to date experience in Leading an EMA Filling (Oncology ideal) along with sound experience with CMA
- Experience in working within a nimble resource environment and closely with a US based Team
- Experience in building EU Regulatory Teams
- Capacity to work cross functionally, especially with Market Access and Medical Affairs/Clinical Development
- Must have effective Strategic and "hands-on" capabilities
- Excellent leadership and organizational skills plus effective written and verbal communication skills, and interpersonal skills are required; must be able to effectively use these skills to influence many diverse internal and external customer groups at various levels within organizations
- Must be experienced in staff and organizational development, motivating personnel / teams, and providing effective coaching, training and development
- Must be detailed oriented, self‐driven and goal‐oriented, and able to multi‐task to achieve results
- Must be able to adhere to strict project timelines and budgets, and to advise teams and management of impacts and changes in project timelines
- Ability to manage changing priorities, evaluate impact, and communicate timeline and resource impacts to project teams and management is required
- Working knowledge of e‐publishing and filing systems/document management systems are an asset
- Bachelor's degree in a scientific discipline is required, with a Masters or PhD degree preferred; equivalent experience may be accepted
- 15+ years pharmaceutical industry‐related experience is required
- 13+ years hands‐on global (EU/International) regulatory affairs experience and knowledge of pharmaceutical (drugs/biologics/devices/combination products) regulations and guidance experience
- 12+ years management experience advantageous
About Mirati Therapeutics
Mirati Therapeutics is a late-stage biotechnology company whose mission is to discover, design and deliver breakthrough therapies to transform the lives of patients with cancer and their loved ones. The company is relentlessly focused on bringing forward therapies that address areas of high unmet need, including lung cancer, and advancing a pipeline of novel therapeutics targeting the genetic and immunological drivers of cancer. Mirati is using its scientific expertise to develop novel solutions in two registration-enabling programs: adagrasib (MRTX849), an investigational small molecule, potent and selective KRASG12C inhibitor, as monotherapy and in combination with other agents, and sitravatinib, an investigational spectrum-selective inhibitor of receptor tyrosine kinases in combination with checkpoint inhibitor therapies. Mirati is also advancing its differentiated preclinical portfolio, including MRTX1133, an investigational KRASG12D inhibitor, and other oncology discovery programs. Unified for patients, Mirati's vision is to unlock the science behind the promise of a life beyond cancer.
At Mirati, we have an unapologetic and relentless focus on our mission to transform the lives of patients with cancer and their loved ones. Patients and their families motivate us to work smarter, faster and better. We are driven by the knowledge that our efforts can one-day deliver life-saving therapies for the people who need us most. Urgency, open-mindedness, accountability and collaboration ground our work. These shared values are central to who we are, what we do and how we do it.
Our people fuel our success. They are fearless and passionate in their daily pursuit of our mission. We are committed to continuing to create a company and experience that attracts and keeps the best people. When you want your days to count and the work you do to matter, discovering and delivering potentially life-changing therapies is more than a job, it's the chance to be part of something bigger.
We believe diverse professional experiences and an inclusive culture can drive better outcomes for patients. We want employees to be authentic and use their perspectives to contribute to our mission in a meaningful way.
Mirati cultivates an environment where:
- An entrepreneurial attitude is encouraged
- Our people are empowered to speak up, embrace the gray and achieve solutions
- Diverse experiences are an important of part making the best decisions
- We laugh and have fun as a work family
No matter the role, we are unified by our passion for helping patients, and are inspired by a single vision - to unlock the science behind the promise of a life beyond cancer. Together, we own Mirati's success.
Learn more at Mirati.com/careers.
Mirati is an Equal Opportunity Employer (EOE) - we celebrate diverse experiences without regard to race, color, religion, creed, gender identity or expression, age, national origin or ancestry, citizenship, disability, sexual orientation, marital status, pregnancy, veteran status, membership in the uniformed services, genetic information, or any other basis protected by applicable law.
Notice to Third Party Agencies: Please note that Mirati Therapeutics Inc. does not accept unsolicited resumes from recruiters or employment agencies.