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“Senior Director of Regulatory Affairs ” – Permanent role –
Reporting to the Global Product Development Director and as part of a global team , The role as Senior Regulatory Affairs Director is responsible for ensuring that regulatory strategies and regulatory activities are effectively executed to meet the business objectives and legal requirements. The Senior Regulatory Affairs Director reports to the Executive Director Product Development, Regulatory and Quality Affairs.
This is an opportunity to work in a key role with a broad spectrum of responsibilities in a small pharmaceutical company and to contribute to the growth of the company. The vision is to support and build the portfolio of products, where the regulatory function plays a crucial role in this activity.
The work is with international focus and performed in close cooperation with international development and licensing partners. Responsibilities include different therapeutic areas, compilation of full registration files, and direct contact with global regulatory authorities. The position also includes project management and international travelling. This is a new position within a fast moving innovative company, opportunity for growth/advancement are attainable and working on a broad product portfolio.
Responsibilities and main tasks:
- Manage the activities of Drug Regulatory Affairs within the field of responsibility ensuring the implementation of appropriate and effective regulatory strategies
- Manage and oversee all relevant maintenance activities potentially including Life Cycle Management strategy
- Provide expert regulatory input to strategic decision making; including portfolio review, prioritization, and external communications
- Provide expert regulatory affairs and regulatory compliance input to in-licensing evaluations and due diligence activities
- Provide advice about drug regulations to manufacturers/scientists
- Coordinate successful submissions and approval of all drug applications
- Ensure that Global Regulatory standards are met and that the deliverables meet strict deadlines
- Coordinate the writing, review and approval of corporate regulatory and quality procedures according to international GMP regulations and assure that the companies sites are implementing procedures in compliance with the corporate procedures
- Keep up-to-date with changes in regulatory legislation and guidelines
- Write and or review comprehensible, user-friendly, clear product information leaflets and labels
- Liaise, negotiate and arrange meetings with regulatory authorities as needed to support the company’s regulatory strategy
- Develop and establish policies and standards that convey the best practices in the company
- Project management to support development of new generic products
Requirements, Skills, Experience:
- BSMS degree in a scientific discipline
- 5 to 10 years’ experience managing a regulatory team for a pharmaceutical company in the US or EU
- Deep experience from pharmaceutical industry from a regulatory affairs perspective
- Knowledge of USA and European pharmaceutical legislation, relevant guidelines – including ICH, procedures and requirements
- Thorough understanding and demonstrated ability to apply regulatory guidelines/regulations to successful dossier preparation, submission and maintenance
- Ability to develop innovative strategies and creative solutions within the regulatory context and within the scope of global requirements and available resources
- Strong initiation and organizational skills
- Outstanding written and oral communication skills, with ability to influence others and negotiate successful outcomes
- Strong analytical skill and technical/ scientific competence
- Attention to details and ability to appropriately assess risks and formulate risk-management strategies, including taking “the big picture” view on various options
- Team-player, able to positively influence team members at all levels with an entrepreneurial “can do” attitude
- Proactive, quick learner and independent worker able to effectively multi-task in a high pressure environment and follow issues through to conclusion
- Experience from working with generics is an advantage
- Experience in pharmacovigilance is an advantage
- Fluent in oral and written English
- Proficient in use of MS-Office applications (e.g. Excel, PowerPoint, Visio, MS-Project)
- Ability to travel internationally and work a flexible schedule based on project needs.
For a confidential discussion and more information on the role, please contact Mary Mullin on 09064 78104 and email your cv to email@example.com
For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie
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