Associate Director, Regulatory Affairs:
CAI is hiring an experienced Associate Director of Regulatory Affairs within their EMA Operations. The successful candidate will provide global regulatory affairs strategic and technical leadership that is required to be followed for the manufacturing of Medicinal Products.
Commissioning Agents, Inc. (CAI) is a rapidly expanding professional services organisation headquartered in the United States with offices in Ireland, Switzerland, Italy, Puerto Rico, Singapore and China. We work in the pharmaceutical, biotechnology, medical device, nutritional and building commissioning industries to provide industry best practices to our clients. We provide services in the areas of quality, compliance and regulatory; automation, commissioning, and qualification; validation, maintenance, and reliability; building commissioning, consulting, and information management systems.
Meeting a Higher Standard
As CAI, we are committed to living our Foundational Principles, both professionally and personally:
· We act with integrity.
· We serve each other.
· We serve society.
· We work for our future.
With employee ownership, one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a Can-Do Attitude (our core values). That is how we have grown exponentially.
You will be responsible for the management of one or more Life Science programs or projects. You will develop an execution plan, form a team, assign tasks, develop a schedule, manage the budget, resolve issues, track KPIs and develop and communicate program reports. You may be assigned to manage internal programs with cross-functional teams comprised of client employees and/or contractors. Alternatively, you may be assigned to lead programs performed by external suppliers in which you will be responsible to manage supplier performance per established contracts and quality agreements. You will interact and engage with stakeholders across the project spectrum and be responsible for driving the project to success.
Able to travel domestically and internationally as required.
Job requirements & responsibilities:
· Responsible for the execution of client global regulatory submissions to project timelines keeping the portfolio in compliance with regulations across the globe.
· Play a pivotal role in managing CMC submissions such as CMC content, development, and meet regulatory compliance guidelines established by the health authorities.
· Have good interactions with the health authorities to ensure drug development is done efficiently and appropriately across regions around the world.
· Support the client in understanding the regulatory environment by serving as an advisor on the FDA/ EMA related guidelines.
· Participate in a variety of activities such as but not limited to preparation of investigational, commercial and post approval submissions negotiating with regulatory authorities personnel to seek approval of pending registrations and respond to queries.
· Can act in a project oversight role for regulatory services, to include managing client relationships for a portfolio of products and be responsible for close liaison with the management/ other key personnel in line with time frames for approval.
· Identify upcoming key changes in regulations and standards in an evolving regulatory landscape and create a knowledge management sharing environment.
· Responsible for developing and implementing a regulatory strategy with appropriate supervision designed to be a door-opener for growing the QCR business and client portfolio.
· Is engaged in industry forums, speaking, writing articles, participating in society committees, supporting standards or guidance document creation within such groups, and has a network of industry contacts who would recognize you as being an expert in emerging regulatory requirements and intelligence to enable key stakeholders to make informed strategic decisions.
· Builds and maintains strong relationships within the European regulatory network including EU Competent Authorities, Notified Bodies and other stakeholders as appropriate to ensure ease of access and influence.
· Work collaboratively with other department colleagues and agents to share best practice and information.
· Develop and grow others in developing and implementing a mentoring plan that supports execution of compelling development plans for our agents.
· Prefer a degree in a science discipline, an advanced degree (Masters or PhD) is preferred
· 10+ years in the pharmaceutical industry with experience working in one or more of the following: QA/QC, CMC, pharmacovigilance, clinical labelling toxicology, safety or non-clinical roles is desirable.
· Must have a robust understanding and functional knowledge of manufacturing/ pharmaceutical science with an understanding of drug development and commercial manufacture.
· Extensive knowledge of EU regulatory requirements including ICH guidelines and global regulatory requirements for assigned territories.
· Must be able to speak scientifically, pick up new information quickly, have a deep understanding of product development.
· Must be able to interpret and explain regulatory guidelines, challenge the status quo, assess risk, and apply risk assessment to the regulatory strategy on behalf of our clients.
· Good planning, time management and attention to detail essential
· Strong communication skills both written and verbal.
· Clear track record of effective team work, collaboration, problem solving and demonstrated leadership ability
· Must have strong negotiating skills and perseverance to put all of their other qualities into action.
· Extensive experience of interacting with scientific committees and working parties of EMA (e.g CHMP) and with National Health Authorities
In return for your skills and knowledge, CAI offers a wide range of benefits including:
· Health insurance, company paid critical illness insurance, Life Insurance, PRSA contribution and more.
· Annual profit sharing
· Paid time off
· Continuing Professional Development and Education (internal and external)
Please contact us to discuss this exciting permanent, pensionable opportunity, during what is an exciting growth phase for CAI.