Associate Director, Regulatory Affairs (Oncology / Haematology)
- Contract Type
Responsible for development & execution of EU submission strategy for assigned projects and for building regulatory dossiers to achieve timely regulatory approvals & maintenance of the existing product portfolio. Liaises with Regulatory Affairs (RA) Franchise Team management & with other internal/external stakeholders. May be responsible for managing & developing staff.
- Responsible for the development of EU regulatory product strategy based on company strategic imperatives, product knowledge, global and regional regulatory requirements, including assessment and inclusion of innovative regulatory pathways to achieve regulatory approvals meeting business needs.
- Responsible for ensuring that EU regulatory product strategy and deliverables are developed in alignment with Regulatory Franchise Team Leadership, Global Regulatory Affairs (GRA) and the Global Project Team (GPT).
- Responsible for the maintenance of regulatory product strategy, proactively identifying emerging issues that may impact regulatory product strategy and the EU regional business. Adjustment of the strategy and implementation plan in response to new information or changes in the competitive landscape. Communicates issues to management as appropriate.
- Responsible for the execution of regulatory product strategy and for achieving timely regulatory approvals with competitive product labels and the maintenance of licenses for products assigned.
- Responsible for the preparation and content of high quality regulatory dossiers (eg., scientific advice requests, orphan medicinal product designation applications, paediatric plan or waiver requests, MAAs and variations), ensuring compliance with regulatory requirements. Reviews key documents before submission.
- Responsible for interactions with the European Medicinal Agency (EMA), and National Regulatory Health Authorities within the EU for product related discussions
- May have global responsibility for specific projects which will require; a knowledge of global regulatory requirements, development and ownership of the Regulatory Development Plan (RDP), responsibility for Worldwide submission plans and accountability for global regulatory documents such as clinical trial/marketing applications and for interactions with global Health Authorities.
- Bachelor's degree in scientific discipline or equivalent required
- Significant experience in the pharmaceutical industry, including considerable period in European Regulatory Affairs with significant recent experience of EU Centralized Procedure required.
- Significant experience in Haematology/Oncology, Biologics and/or ATMP required
- Expert knowledge of current EU regulatory requirements essential
- Expert understanding of CTD modules; non-clinical, CMC, Clinical
- In-depth knowledge of core processes of drug discovery, development, manufacturing & marketing required.
- Good knowledge of TA assigned
- Significant experience of interactions with European Health Authorities
- Success in matrix management experience required.
- Effective leader. Leads teams in project execution & delivery.
- Experience of leading complex regulatory submissions including MAAs.
- Demonstrates appropriate decision making
- Conveys trust in others' knowledge, skills & judgment & provides direct reports & team members with appropriate levels of autonomy & decision-making authority
- Displays a willingness to challenge the status quo & take risks
- Acknowledges others who take the initiative to try new approaches even if the results are not perfect
- Escalates issues appropriately & understands how far issues should be escalated
- Strong verbal and written communication skills at all levels of the organization & with external stakeholders
- Communicates effectively with Regulatory Authorities as required
- Obtains cross-functional alignment through effective communication.
- Ability to influence internal & external stakeholders to obtain desired outcome
- Actively engages in professional development
- Sets an example by their consistent professional behavior
Office based in West London (1-2 days from home)
6-12 month contract / Full-time
Attractive hourly rate
ABOUT PLANET PHARMA
Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.
Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.
We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.
If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone Sam Chapple on +44 (0)203 868 8607 or e-mail on email@example.com
If this role isn’t suitable for you, please let us know if you can refer anyone – any recommendations are much appreciated! Planet Pharma offers a competitive referral scheme so you will be rewarded for your help!