At ProClinical, we are seeking an individual to fill the role of Director, Regulatory Affairs (Pharma), based in Cincinnati, OH. The successful individual will possess strategic leadership skills and will have deep experience in North American (US and Canada) regulatory science and overall drug/biologic development processes and strategies.
- Develop and implement regulatory strategy for a product and/or group of products. Ensure that strategy is designed to deliver a rapid approval with advantageous labeling.
- Lead and develop a regional and/or global regulatory strategy that is reflective of applicable domestic and international requirement.
- Conduct relevant internal assessments.
- Serve as the single point of contact with sponsors and internal teams for select projects.
- Accountable for the delivery of regulatory milestones.
- Accountable for post-market application maintenance and compliance activities.
- Ensure effective regulatory representation in partnership with appropriate technical experts at all health authority meetings and clear documentation of the discussion and agreements.
- Lead regulatory strategic development, communication and updates and ensure appropriate consultation and peer review.
- Monitor changes in the regulatory environment, and support teams and department staff accordingly.
- Provide regulatory leadership as needed in early development and due diligence review projects.
- Participate in skill development, coaching, and performance feedback of other regulatory staff.
- Manage relationships with competent authorities through frequent interaction.
- Plan, review and approve required documents from various departments for filing of required information to regulatory bodies.
- Provide regulatory review of study protocols, investigator's brochures, labeling, and integrated summary documents.
- Collaborate with EU regulatory to develop global approval strategies.
Skills And Qualifications
- Advanced degree in related field (MD, PharmD, PhD) required.
- 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.
- Experience in attending and/or helping a team prepare for a Major Health Authority interaction.
- Broad background of experience working in pharmaceutical business.
- Strong written, verbal, and interpersonal communication skills.
- Less than 10% of travel required.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Mary Jacobs at (+1) 2674774800 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.