Reference Number: JO-2102-462310
Director, Regulatory Affairs
Job Type: Permanent
Location: Central London / West End
Role: Director, Regulatory Affairs
Location: Central London
Salary: Highly competitive + benefits
employment: full time, permanent
Regulatory Professionals are collaborating with a midsize, clinical contract research organization. They provide services for Phase I-IV of drug and medical device development services including regulatory services and central laboratory services. Our client is seeking a highly experienced regulatory affairs professional who will be accountable for the development and implementation of the regulatory strategy for specific Sponsor projects. In this role, you will be responsible for managing 3-4 employees therefore, line management experience would be highly advantageous.
Other duties will include:
- Responsible for the development and implementation, at a regional or global level, of the regulatory strategy for a product/ group of products and for ensuring that the strategy is designed to deliver a rapid approval with advantageous labeling in keeping with the properties of the product(s) and the needs identified by the Sponsor;
- Leads and develops a regional and/or global regulatory strategy that is reflective of applicable domestic and international requirements.
- Conducts assessments such as regulatory gap analyses, considerations, and strategy, risk planning, and mitigation.
- Serves as the single point of contact with Sponsor and internal teams for select projects, with key contributing members from department staff.
- Accountable for the delivery of regulatory milestones including assessment of the probability of regulatory success together with risk mitigation measures.
- Accountable for post-market application maintenance and compliance activities.
- Partner with department staff to influence developing views/guidance within leading Health Authorities on specific topics of relevance to their project or regulatory more generally.
- Lead the regulatory staff working on a product/project to ensure prioritized objectives that focus on the critical activities are successfully delivered to time and quality.
- Ensure effective regulatory representation in partnership with appropriate technical experts at all health authority meetings
- Monitor changes in the regulatory environment, both general and specific to the therapeutic area, and support and advise teams and department staff accordingly
- Participate in skill-development, coaching, and performance feedback of other regulatory staff working on the product/project.
- Manage relationships with competent authorities through frequent interaction.
- Plan, review, approve required documents from various departments for filing of the required information to FDA, including, pre-IND and other consultations with FDA, new IND’s, updates to IND’s, and original/supplemental NDA filings.
- Provide a regulatory review of study protocols, investigator’s brochures, labeling, and integrated summary documents.
- Collaborate with EU regulatory to develop global approval strategies.
- Provide regulatory advice and guidance to project teams to ensure submissions meet regulatory requirements.
- Supervise, develop, and mentor regulatory personnel.
Knowledge & Skills
- Right to work in the UK
- Advanced degree required. Preferred degrees include PharmD, MD, and/or Ph.D.
- More than 8 years of experience or equivalent of regulatory drug development including product approval/launch. Expert knowledge of regulatory affairs within one or more therapeutic areas
- Previous experience in attending and/or helping a team prepare for a Major Health Authority interaction (e.g. FDA advisory committee meetings, Oral explanations, Scientific Advice, Pre-NDA/BLA, EOP2 meetings, etc.)
- Broad background of experience working in the pharmaceutical business
- Proven leadership and program management experience
- Ability to think strategically and critically evaluate risks to regulatory activities
- Successful contribution to a major regulatory approval at a global or regional level
- A scientific and clinical understanding of the regulatory sciences
- Must demonstrate competencies of strategic thinking, strategic influencing, innovation, initiative, leadership, and excellent oral and written communication skills.
If you would like to apply for this position, please contact Amani via amani.yousef@CPL.com. If you are not currently looking but know someone who would be good for this role then get in touch. We offer a referral scheme at CPL Life Sciences where in which a successful recommendation will earn you £250 worth of vouchers *terms and conditions apply*