About the role:
Reporting directly into the Senior Director of Product Development, the key skills required to be successful in this role are an understanding of drug development and registration process in pharmaceuticals, excellent attention to detail, proactive nature and confident communication both within the business and with external partners. The ideal candidate would also be a problem solver with an inquisitive mind and appetite to develop their technical skills.
The department has an ethos of continuous improvement, refining systems and creating efficiencies. This, along with the rapid growth of the business, leads to a varied and dynamic working environment.
Main responsibilities duties:
- Review of technical documents like: Specifications, Test Procedures, Process Validation Protocols/ Reports, Batch Manufacturing Records etc., ready for regulatory submission
- Authoring the relevant technical modules for dossier compilation ready for submission
- Mapping out and review of product development and/or regulatory strategy in line with project timelines
- Review of ASMF/DMF from API supplier as per product development/regulatory strategy
- Review and authoring scientific rationale/justification to RFIs received from regulatory agencies and/or other departments
- Active involvement in building/authoring/review of pre-submission/SA/pre-IND/NDA meeting package for submission planning
- Review of Clinical/BA/BE Protocol and coordinate with relevant Subject Matter Experts
- Active involvement in building global product development/clinical development and regulatory strategies.
- Due-diligence of in-licencing and acquired products
- Communication and coordination with the internal and/or external stakeholders for preparation/review of technical documents
- Provide project updates regularly to Project Management team and Execs
About you:
Candidates with relevant technical authoring/regulatory experience within a large-scale or multinational pharmaceutical company are likely to have the skills required to be successful in this role. We are also looking for:
- Master's degree in Pharmacy (M.Pharm)
- Substantial relevant experience in technical authoring/regulatory, including Module 2 to 5 (CTD) authoring
- knowledge on recent and updated regulatory and technical guidance
- Proficiency in reviewing and authoring technical documents, including clinical package.
- Excellent analytical and problem-solving abilities
- Strong presentation skills
- Ability to work effectively in a fast-paced environment and meet tight deadlines
- Ability to build strong working relationships with internal and external stakeholders
- Exceptional verbal and written communication skills
- Self-motivated and a team player
- High level of integrity and professionalism
