Regulatory Officer Roche Pars

  • Full Time

  • Tehran

      -   Tehran

Regulatory Officer

Posted Long ago

Job Description

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

Requirements

University Qualifications: 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. Specialist Knowledge: - 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