List of Responsibilities:
1- Effectively and timely support regulatory for product management:
- Stay abreast of internal and external developments, trends and other dynamics as these potentially influence Roche’s pipeline and marketed products and other business interests
- Supports regulatory activities according to the regulatory strategy to achieve the best business outcomes for Roche Iran
- Ensure all regulatory applications and activities occur within defined timelines according to regulatory guidelines and business requirements
- Assess product dossier information received
- Assess and report on fees for regulatory submissions
- Review activities on a regular basis with RAM and any other internal business partners and stakeholders
- As needed, liaise with various internal departments and personnel to request clarification or additional data
- Collate and prepare regulatory submissions
- Circulate regulatory submissions for internal approvals according to legislative and regulatory requirements, local, regional and global Standard Operating Procedures (SOPs)
- Submit final, reviewed regulatory submissions to health authorities
- Respond to regulatory questions from internal customers and/or questions from health authorities, as these may arise
- Undertake issues management as needed/when necessary
- Responsible to ensure regulatory activities across therapeutic areas are consistently completed and executed in full compliance with Roche SOPs, legislative and regulatory requirements
2- Ensure timely, accurate and compliant regulatory documentation, systems and procedures:
- Ensure Regulatory Affairs records are updated with current regulatory activities, timelines and priorities
- Develop and maintain regulatory resource documents, including SOPs, working instructions, etc.
- Ensure all work instructions and other regulatory information are current and accurate
- Manage electronic filings of regulatory documentation post-health authority approval
- Provide cross-functional teams with revised product registration details
- As appropriate or requested, participate in or otherwise supports internal and/or external audits
3- Effectively collaborate and communicate cross-functionally:
- Attend relevant meetings and contribute to cross-functional team work and effectiveness
- Complete routine and ad hoc reporting of departmental activities and statistics
- Keep internal business partners and stakeholders abreast of progress relating to submissions including communicating any real or potential risks or other issues
- Develop and maintains professional and credible relationships with internal partners/stakeholders, health authorities and customers
- Under the guidance of RAM, communicates with health authorities and key customers
- Attend a variety of external seminars and other professional programs and share information and knowledge with other team members
- When assigned, participates in special departmental projects or other initiatives, which may include continuous improvement and streamlining of departmental processes, systems and other resources
Bachelor's degree in Medicine/Pharmacy (additional business degree would be an advantage).
Nature and length of previous experience:
3+ years of experience within the pharmaceutical industry in the country, preferably in regulatory affairs.
- Past experience working with health authorities and relevant governmental departments
- Familiar with code of conduct and Pharma regulations
- Knowledge of relevant therapeutic area
- Knowledge of the overall drug development process relevant to pharmaceutical/biotechnology organizations processes
- Good Relationships with external TAEs, other thought leaders, and external organizations is strongly preferred
- Advanced knowledge of Microsoft Office suite: Word, Excel, PowerPoint
- Fluency in Farsi & English (written and verbal)
Soft Skills and Personality Traits:
- Outstanding attention-to-detail and customer service skills
- Strong business acumen: in-depth knowledge of the pharmaceutical industry, the multiple stakeholders involved and the roles each play
- Strong analytical and problem-solving skills
- Good organizational skills and time management: has a track record of consistently meeting or exceeding assigned goals and objectives
- Strong influencing skills: can influence without authority and has proven experience building and cultivating relationships with key partners/stakeholders
- Project management skills
- Results orientated
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