Job Description
This is a rare opportunity to join a young, exciting clinical-stage biotechnology company.
Our client is a clinical-stage neuroscience company focused on the discovery and development of novel therapies with the potential to fundamentally change the course of progressive, life-threatening diseases.
Job Spec
- Lead in the preparation, submission, and maintenance of regulatory applications, including clinical trial applications (CTA), routine CTA amendments, pre & post authorization regulatory submissions and annual reports.
- Lead in the preparation, review, and submission of high-quality responses to questions to regulatory agencies.
- Ensures submissions are complete, properly formatted and comply with applicable regulatory requirements and timelines.
- Assist in interactions with regulatory authorities, including coordination with external contractors.
- Ensures document management and archival systems are maintained.
- Effectively collaborates with development team counterparts to ensure submission goals are met.
- Assist Development teams and Regulatory senior management in developing strategies that are EU-appropriate and take advantage of EU regulatory systems and processes, in particular the application of innovative regulatory pathways to our development products.
- Responsible for planning and ultimately leading MAA related processes and strategy to ensure timely product approvals with competitively differentiated labelling.
- Monitor emerging legislation and guidance in the EU and contribute to ensuring company-level awareness and compliance (where appropriate).
- Provide support to department liaisons with their project specific communications and issues, including Agency meetings, responses to CTA challenges and CRO oversight as required.
- Ensure emerging issues are flagged to EU regulatory leadership in a timely manner.
- Other relevant activities as assigned by the Senior Director of Regulatory Affairs.
- Bachelor’s Degree/Science degree in a biological science is required. Equivalent combination of education and applicable job experience may be considered.
- 3-5 years regulatory affairs experience in the pharmaceutical or biotechnology industry or government health agency.
- Good knowledge of the drug development process is required.
- Ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyse data, establish facts, and draw valid conclusions.
- Experience in interpretation and application of ICH and EU guidelines relevant to product development and submission of pre/post authorization applications
- Experience in drafting and reviewing regulatory submissions (CTA, MAAs, Variations).
- Experience with the EU Clinical Trial Regulation (CTR) is desirable.
- Demonstrated leadership to drive results that are needed to achieve the company objectives in accord with the company’s culture and values.
- Ability to manage various projects, solve problems, deliver on commitments and work with multidisciplinary teams.
- Independent, self-starting individual with a demonstrated ability to thrive in smaller, biotech environment is required.
- Strong interpersonal and organizational skills and excellent verbal and written communication skills are required.
- Some flexibility in hours will be required for participating in international teleconferences.
- Ability to travel 10% domestic and internationally.
Gerry Kennedy, Managing Director, Recruitment for Technology Ltd. Cv to gerry@rftgroup.ie
Maple House, South County Business Park, Leopardstown, Dublin D18 F863