headcount AG is a Zürich based consultancy, specializing in pharmaceutical, medical technology & biotechnology recruitment, as well as employment market intelligence.
We count several top ten pharmaceutical companies as clients, as well as many further smaller biotech and medical technology organizations. Our client for this particular recruitment is US-based biotech on the verge of its first approval.
The Head of Regulatory Affairs, International is responsible for developing and proposing thoughtful and thorough European (EMA, UK, further markets) regulatory strategies to support the development and commercialization of our client's pharmaceutical products. The person in this role will manage and provide leadership for the development and commercialization strategies of our client's products in development and, when applicable, manage post-approval regulatory maintenance activities and strategies.
Further, the person in this role will need to work closely with the Global Regulatory Leaders and department management to develop effective global regulatory strategies appropriate for the stage of development as well as for long-range planning, focusing on the clinical, nonclinical, CMC, and operational aspects of the program. This person is responsible for ensuring the timely and high-quality execution of the European and international strategies.
_Support internal project development teams and interact with external business partners and EU, UK, and further international health authorities
_Define regulatory strategy in collaboration with cross-functional stakeholders.
_Working closely with the GRL's and department areas (Operations, Submission Management, CMC, and Commercial Support), ensure accurate and comprehensive development of EU and UK regulatory submission and life cycle management regulatory strategies
_Oversee development and execution of detailed tactical plans consistent with the overall strategy
_Assist in the management and oversight of relevant clinical stage and marketing authorization stage regulatory submissions and interactions;
_Review documents intended for submission to regulatory agencies to ensure they meet regulatory requirements and internal quality standards
_Experienced biopharmaceutical professional with a minimum of 10-15 years of relevant pharmaceutical/biotechnology experience
_ Experienced regulatory professional with a minimum of 8 to 10 years of relevant experience and a proven track record of EU (EMA and EU country-specific competent health authority) regulatory submissions
_Recent hands-on experience with the planning and submission of CTAs and MAAs in electronic format
_Experience leading or participating in regulatory agency interactions
_Must have a solid foundation in science obtained through academics and business experience
_Must be a strong team player, a fully engaged, hands-on professional capable of working collaboratively and independently, with excellent verbal and written communication skills
_Strong knowledge of EU Directives and guidance documents pertaining to pharmaceutical drug development, including knowledge of evolving global requirements for electronic filing of regulatory submissions
_Expert regulatory knowledge including FDA, EMA, PMDA regulations, and ICH guidance
You could be the one to really make a difference - to those patients who need life-changing medications across Europe.
I look forward to receiving your application!
Please forward your application should you meet the requirements above - applications that do not meet these requirements will not be considered