Exciting role with significant opportunity for personal growth and development!!
Applications are invited for a permanent position of Senior Regulatory Affairs Associate. This regulatory role will involve the coordination, preparation and maintaining of a variety of regulatory submissions (primarily CMC related) to support both development and commercial products.
- Collection, review and preparation of documentation in support of regulatory submissions to regulatory agencies in the EU, US and other international agencies.
- Regulatory support for R&D team for development projects.
- Regulatory support for third parties for out licencing activities.
- Maintain departmental cGMP documentation (authorisations and Site Master File) and participate in cGMP project initiatives.
- Develop and maintain current regulatory knowledge.
- Participate in the management of controlled substance systems for the site.
- Create timelines and tracking deliverables to ensure that all submissions are submitted on-time.
- Review and approve change controls related to proposed products/process changes and their impact on specific regulatory applications.
- Plan and initiate projects based on consultation with Manager.
- Update and maintain regulatory information management system as part of on-going responsibilities.
- Attend relevant functional area and project team meetings as required.
- Participation in initiatives aimed at improving internal regulatory standards.
- Build productive working relationships within the global Regulatory team and other departments.
- A minimum of BSc or equivalent degree in scientific discipline.
- Minimum of 4 years relevant regulatory pharmaceutical experience.
- Clear understanding of content and organization of regulatory submissions in eCTD format, as well as ICH and FDA guidance’s.
- Demonstrated track record of hands on experience in writing and reviewing Module 2 and 3 CMC documentation for drug products and drug substances for inclusion in a wide range of global regulatory CMC filings (e.g. DMF, IND, IMPD, MAA, NDA). In particular, previous experience with authoring DMFs is highly desirable.
- Detailed knowledge and interpretation of EU regulations and working knowledge of US and other countries.
- Motivated, self-starter with the ability to work independently with minimal supervision under tight deadlines.
- Ability to work effectively in a team/matrix environment and build productive working relationships within the Regulatory team and other departments.
- Excellent attention to detail.
- Strong written and verbal communication skills including presentations.
- Demonstrates a sense of urgency around meeting commitments and timelines.
- Copes with changing priorities and a demonstrated ability to prioritize multiple projects.