Senior Regulatory Affairs Manager, Global – Oxford – Permanent
Nicholas Howard Limited are delighted to be recruiting for a new and exciting role as a Senior Regulatory Affairs Manager, Global.
Based in Oxford, the Senior Manager for Global Expansion ROW, will be responsible for leading cross-functional teams for new ROW registrations, as well as managing the on-going life-cycle maintenance activities for assigned products covering ROW markets. Regulatory filing and life-cycle maintenance activities will also be coordinated in collaboration with in-country partners.
The successful candidate will be responsible for executing the regional regulatory strategy pertaining to the development, registration and regulatory compliance of products in the ROW markets as dictated by the business objectives. This will include interacting with the relevant groups as needed to ensure timely submission and approval for products in these markets.
- Provide regulatory support and expertise for the ROW (AsiaPac, LATAM, MENA) portfolio of products.
- Ensure ROW filing strategy is appropriately represented within the Global Regulatory Team (GRT) and at other appropriate forums (Global Development Team etc.).
- Lead and manage more junior roles, as required.
Required Knowledge, Skills & Abilities:
- Minimum of 7 years’ experience in the pharmaceutical industry, with minimum of 5 years direct experience in ROW registration activities preferred.
- Planning & management of all allocated projects and ensuring timely delivery of these projects.
- Collaborate with cross-functional team to develop and implement regulatory strategies based on organisational priorities and resource availability.
- Ability to work cross-functionally and in collaboration with key internal stakeholders/customers (e.g. commercial, technical, quality, medical, supply chain etc.).
- Working knowledge of regulatory requirements and cultural differences for various country registrations and maintenance activities (e.g. local regulatory partners, local distributors and MA holders, regulatory agencies).
- In addition to working in cross-functional teams, must also be able to work successfully as an individual contributor, with a high level of professionalism.
- Proven experience in regulatory affairs with particular focus on initiating and managing new ROW registrations and life-cycle maintenance activities (e.g. Variation applications including new indications, Renewals, PSUR submissions, Notifications, MA transfers, MA cancellations).
- Act as contact point / knowledge base for scientific & technical aspects of Module 1 documents and associated regulatory activities.
- Ensure compliance with product post-marketing approval requirements.
- Timely filing of complete, high quality regulatory submissions; prompt, complete and accurate management of responses to Health Authority questions and effective communication of approvals.
- Ensure that all submissions comply with the current regulatory guidelines and legislation at all times. Ability to review regulatory documents for accuracy and adherence to regulatory requirements, noting deficiencies and inconsistencies.
- Ensure 100% accurate and complete archiving of all submissions, approvals and regulatory agency correspondence performed in ROW markets. Ensuring that regulatory document management system contains the most current and accurate information.
- Excellent verbal and written communication skills and collaborative interpersonal skills.
- Ability to travel occasionally – approximately 10-20% regional and / or international travel.
- Responsibilities may require working outside of “normal” hours, in order to meet business demands.
Required / Preferred Education and Licenses:
- Bachelor’s degree (Scientific discipline preferred) or equivalent in industry related experience.
To be considered for this position please apply below.