We are looking for a Junior Regulatory Associate to join our expanding team. The successful candidate will:
- Be responsible for the review and finalization of Global Regulatory Strategy Documents, CTD sections for IND, CTA, BLA, NDA, and ANDA submissions to ensure effective data presentation as per guidance
- Be responsible for effective co-ordination with cross functional teams, site, and global Regulatory Affairs teams for the authoring, review, and finalization of dossiers for the pipeline products to ensure effective data presentation and quality
- Prepare quality dossiers for pipeline molecules and supplements to support product launch.
- Monitor and set timelines for filing MA transfers, variations, license renewals, product amendments/supplements, and other product life cycle management activities including annual reports and safety report filing, etc.
- Collaborate with both global and other regional regulatory client teams to author quality regulatory submissions for pipeline products
- Review Health Authority queries and co-ordinate global strategy for response
- Provide adequate support, including responding to deficiency letters, to both global and other regional regulatory client teams for securing timely approval of regulatory submissions
- Provide regulatory support to team, participate, and provide regulatory advice in technical review.
- Identify and assess regulatory risks associated with assigned projects and timely communication to the team to quickly mitigate any risks
- Drive resolution of issues. Communicate issues, impact, and outcomes to global regulatory management and core team.
- Keep up to date with international legislation, guidelines, and customer practices in all countries that the client is exporting its products to
- Undertake and manage regulatory inspections
- Be knowledgeable of current regulations and guidance, interpret and implement for assigned projects
- Responsible for ensuring compliance to clients submission standards, policies, and procedures
Desirable Skills and Experience
- 2 – 5 years’ experience in a regulated life sciences environment
- Significant hands-on registration experience associated with the development, maintenance, and commercialization activities within Regulatory Affairs (Human Medicinal Products); preferably from the perspective of CMC writing and authoring, review and approval of labeling documents
- Proven ability to successfully understand regulatory implications of product strategy with regard to the product label, assessment, and practical management of associated impacts
- Demonstrate the ability to interpret and apply regional/local regulatory guidance for CMC and safety related filing in the pre-approval and post-approval (maintenance) stages
- Demonstrate the ability to develop strong and positive working relationships across multiple cultures and locations
- Knowledge of global/regional regulatory guidelines and requirements important
- Proven strength in logical, analytical, and writing ability essential
Bachelor’s Degree in Science or industry related
22 Jul 2021