Associate Director Regulatory Affairs
- Experience Level
Exciting role as Associate Director of Regulatory Affairs in Oncology. We would love to hear from you if you are based in Europe and considering roles like this but want to be based in your home country as the location is negotiable.
Are you a regulatory professional at the pinnacle of their career and looking for a lucrative role where you have direct impact on patients? I am currently exclusively partnered with an exciting international family-owned innovative pharmaceutical company with ambitious growth plans in oncology. My client is expanding their innovative pipeline in oncology to become a future leader in the field and serve their patients to a greater extent. If you are someone that is motivated by innovation, transparency and novel molecules as well an employer that invests in their employee’s as well as patients then please read on.
In their latest recruitment drive in the company’s expansion, they are seeking a Global Regulatory Lead to sit at either Associate Director level or a Senior Manager in regulatory affairs. The ideal candidate will be innovative, forward thinking and a key player in the RA field. The role will be based in Italy but this is being discussed and negotiable and a lucrative relocation package is on offer for anyone needing to move as well as a significant financial package that sits above market rate in Regulatory Affairs.
The ideal applicant will have experience in the following:
- At least 7 years’ experience in Regulatory Affairs
- Extensive operational knowledge in Oncology Regulatory Affairs – however similar therapy areas may be considered
- Extensive experience in interacting with Regulatory Agencies, FDA, EMA et al
- Leading scientific advice interactions with agencies
- Leading strategy in previous roles
- Preferably an understanding and care for the cancer patient community
The job responsibilities include:
- Acting as a key contributor for the successful development of the company pipeline
- Responsible for the implementation of the regulatory strategies for the oncology pipeline.
- Providing overall regulatory guidance and oversight for all assigned products in order to obtain the optimal label and the shortest timing to approval by Regulatory Agencies.
- Interaction with EU and US Regulatory Agencies and define the global regulatory strategies and registration requirements for one or more products.
- Coordinate the preparation, review and submission of IND, clinical trial applications, amendments, responses to Agencies’ questions and requests, meeting requests, briefing packages, annual reports, etc.
- Coordinate the preparation, review and submission of NDAs, BLAs and MAAs.
- Managing a team of regulatory professionals
- Leadership skills in a matrix environment.
- Proven track record of success bringing new products to registration.
- Prior experience in managing and submitting INDs, CTAs, BLA, NDAs, MAAs.
- Exceptional interpersonal skills with the ability to work in a global environment, individually as well in multi-disciplinary team, and with external partners and regulators.
- Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders.
- Proven ability to consistently deliver within defined timelines, cost and quality standards
For more information or to have a confidential conversation about this role and other international, global and regional regulatory affairs opportunities, please apply or contact me at email@example.com and I will be happy to organise a call with you!