Purpose of the Role
The Regulatory Affairs Associate is responsible for implementation of the Regulatory Affairs Strategy. The Regulatory Affairs Associate shall support the Regional Regulatory Affairs Manager and the Regulatory Affairs team members and collaborate with the Franchise Leads and external partners to ensure achievement of Regulatory affairs objectives, in line with the business goals.
Required Competencies, Qualifications and Experience
- Graduate, with Degree in Life Sciences
- Preferable with Masters in Life Sciences, MBA, etc.
- Minimum of 2 years proven performance and experience in a regulatory executive role in an MNC Pharmaceutical/healthcare company in the MENA Region
Responsibilities & Accountabilities
Regulatory Affairs:
- Liaise with the Group Therapy Area to identify and provide regulatory guidance.
- Apply regulatory expertise for the respective products to enable preparation of high quality documentation and assure compliance with departmental procedures.
- Co-ordinate with Regulatory Affairs Team Members regarding the receipt, distribution and response to regulatory queries from target countries.
- Ensure that response targets are met.
- Assist in the preparation of regulatory strategies and plans for the relevant product portfolios, including review of regulatory guidelines and relevant literature.
- Build and assure dispatch of customized dossiers to the markets.
- Develop detailed understanding of regulatory guidelines and technical requirements in the assigned markets and a broad understanding of the global regulatory environment for the products.
- Develop specialized areas of expertise in assigned regulatory topics and countries.
- May undertake assigned regulatory projects, including review of guidelines and contribute to the improvement of departmental and divisional processes.
- Ensure business compliance and implementation of and adherence to Regulatory standards.
- Ensure that comprehensive records of communications, country requirements and regulatory status, are maintained.
- Regular follow up on progress on regulatory submissions with the regulatory Access team in the markets.
- Ensure that line management are advised of progress in regulatory filings.
Project Management:
- Ensure product strategies, submission and approval timelines, and country registration requirements/guidelines are accurately captured and current in applicable systems/regulatory databases.
- Ensure notifications of proposed regulatory changes and approvals are communicated to relevant stakeholders in a timely manner.
- Participate and/or lead cross-functional project teams, to address business needs in line with Commercial Teams, Marketing, Medical Functions, and Regional and market business objectives.
- Represent countries at relevant regulatory and project teams
- Ensure that comprehensive records of communications, country requirements and regulatory status, are maintained.
- Regular follow up progress on regulatory submissions with Access teams and/or distributors.
- Contribute to the development of filing and approval goals for the region.
- Lead and implement regulatory process and procedure improvement activities
- Ensure that line management and functional heads are advised of progress in regulatory filings for the respective product(s)
Others:
- Provide training to internal stakeholders and partners (as required)
- Expert knowledge in Regulatory Affairs for the assigned product portfolio(s) in the markets
- Support and collaborate with other Regulatory team colleagues and cross functionally, and externally with the Partners
- Support the Senior Director, Regulatory Affairs and the Regulatory Affairs Manager to achieve the goals of the function, and the business overall
