Back to Job SearchROLE OVERVIEW
An innovative clinical-stage biotechnology organisation is currently seeking a Regulatory Affairs Contractor to join their Regulatory Affairs team. As the Regulatory Affairs Contractor, you will play a key role in the development and execution of global regulatory strategy, supporting clinical development programmes across multiple regions and working closely with cross-functional stakeholders.
This is an initial 6-month contract opportunity based in the Boston, Massachusetts area. The team has a preference for US-based candidates and would ideally like someone who can spend time onsite regularly,
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Regulatory Affairs Contractor will be varied; however, the key duties and responsibilities are as follows:
1. Develop and execute regulatory strategy for assigned clinical development programmes, ensuring compliance with applicable global regulatory requirements and supporting overall programme objectives.
2. Lead and support the preparation, review and execution of global regulatory submissions, including INDs, CTAs, NDAs, MAAs, Paediatric Investigation Plans (PIPs), Orphan Drug Designations and expedited development pathway applications where applicable.
3. Act as a key regulatory representative within cross-functional teams, collaborating with Clinical Development, Medical Affairs, CMC, Quality and external partners to support successful programme delivery.
4. Support Health Authority interactions, including preparation of briefing documents, responses to agency questions, Scientific Advice procedures and regulatory risk assessment activities.
ROLE REQUIREMENTS:
To be successful in your application to this exciting role as the Regulatory Affairs Contractor, we are looking to identify the following on your profile and past history:
1. Relevant degree in Life Sciences, Pharmacy, Biotechnology or a related scientific discipline.
2. Extensive Regulatory Affairs experience within a biotechnology or pharmaceutical environment, supporting clinical development programmes and global regulatory submissions.
3. Working knowledge and practical experience of FDA, EMA and ICH regulations, with experience supporting Health Authority interactions and regulatory strategy development.
Key Words:
Regulatory Affairs / Clinical Regulatory Affairs / Regulatory Strategy / Oncology / Biotech / Biotechnology / Clinical Development / FDA / EMA / ICH / IND / CTA / NDA / MAA / PIP / Orphan Drug Designation / Scientific Advice / Health Authority Interaction / Drug Development / Clinical Trials / Regulatory Lead / Global Regulatory Affairs
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
