Job Description:
- Manage regulatory projects and activities in accordance with company objectives.
- Active participation/contribution in meetings pertaining to products update and strategy.
- Develop registration strategies, prioritizing assignments, implement regulatory plan and coordinate projects and activities in accordance with strategic company objectives.
- Ensure that the regulatory strategy is designed to deliver timely approval with desired labeling.
- Plan and execute regulatory submissions for new products, new indications, renewals and required changes to maintain current registration of all products, in alignment with planned timelines.
- Provide regular registration status to management
- Communicate regulatory issues and evaluate the impact on the business
- Manage development projects, including early pipeline products, from regulatory perspective, where required.
- Participate in cross-functional team meetings
- Support local business teams in activities such as tenders, as required, from a regulatory perspective.
- Provide regulatory input and support for marketing plans, product launches and other cross-functional activities.
- Provide regulatory leadership as needed in product in-license/due diligence review, where applicable.
- Maintain global regulatory systems and databases to ensure that all relevant regulatory information is updated.
- Ensure proper filing of and maintenance of local documentation as per corporate procedures.
- Streamline regulatory affairs processes to increase productivity, where applicable.
- Support local SOPs preparation and maintenance relevant to regulatory affairs to comply with global SOPs and policies and ensure compliance with regulations.
- Support sales and marketing colleagues by providing adequate and relevant regulatory information.
- Keep abreast of changes in the regulatory environment to assure accuracy and effectiveness in regulatory submissions and assess its impact on business and communicate changes in a timely manner to relevant stakeholders and management.
- Conducts regulatory risk assessment and mitigation plans.
- Maximize opportunities to expedite registration processes in each country.
Interested applicants, please email your resume to Alvin Lee Peck Keong
Email: [email protected]
CEI Reg No: R1104781
EA Licence No: 99C4599
