Regulatory Affairs Manager/ Strategist (Regional, Pharma/ Medical)
- Accountable for creating the post approval submissions for Drug Products for country acceptability in terms of content, according to local regulations and requirements for assigned markets. This includes HA query management.
- Ensure dossiers (Example: electronic, paper copy, and HA portal) are produced and dispatched to assigned markets according to their defined filing plan, and are submission ready.
- Ensures the processes transparency and excellence in execution of regulatory strategies.
- Maintain systems and databases per internal SOPs and policies.
- Work in collaboration across the regulatory organization with stakeholders (such as Product Strategist and in-market Strategists) to deliver efficiencies in Regulatory submissions and processes.
- Manage post approval submissions for a small group of assigned market(s)
- Manage post approval strategy (including timelines) and execution in alignment and partnering with key stakeholders (i.e. PGS, Markets, Clusters, Labeling team, Submissions Management, CMC) to ensure a submission ready dossier for the assigned market(s).
- Liaise with CMC Product Strategists. Ensure that the appropriate regulatory requirements systems and database are updated in a timely manner when changes occur in regulations for assigned markets
- Ensure a submission planning and forecasting tool is utilized to update timelines when necessary, communicate changes to relevant partners
- Capable of authoring some local submission components in relevant databases
- Ensure submission packages are reviewed against local CMC requirements for consistency and completeness
- Liaise with the manufacturing sites for obtaining supporting documents as needed
- Ensure thorough understanding and application of the Hub procedures
- Participate in local and regional regulatory initiatives promoting a culture aligned with company values and which supports compliance, innovation and talent development and retention.
- Assist in ensuring internal regulatory processes and procedures are well documented.
- Understand local regulations and trends for assigned markets, as communicated by the PCO.
- Manage adhoc initiatives or projects, as required.
EDUCATION AND EXPERIENCE
- Min Degree in any science related field
- Minimum 5 years of experience in either domestic and regional regulatory affairs would have an advantage
- Familiar with regulatory affairs such as NDA, variation and renewal of product registrations in Pharmaceutical industry (manufacturer or distributor) would be at an advantage
- Pharmacovigilance (or safety monitoring/reporting) experiences preferred but not mandatory
- Project strong initiatives to establish the operating procedures for a new start-up organization.
- Detail-mindset, responsible, well-organized
- Strong communication and interpersonal skill in shared office environment.
- Pro-active and positive mindset
- Able to Prioritize tasks and workload
If you are interested in the position, do kindly drop your most updated resume to [Click Here to Email Your Resume] (Attn: Regulatory Affairs - Leon)
Leon Leong De Cong
EA License: 99C4599
Recruit Express Pte Ltd
Recruit Express Pte Ltd