Our client, a Global Pharmaceutical Company has opened a new vacancy and is looking to recruit a Regulatory Regional Strategist on an initial 12 Month contract to be based at their office in Surrey.
- Accountable for supporting initial and post approval submissions for country acceptability in terms of content, according to local regulations and requirements for assigned markets including HA query management.
- To apply knowledge and interpretation of regulatory requirements in the assigned countries to enable efficient and effective registration of medicinal products consistent with the supported regions commercial objectives.
- To build local relationships and ensure communication/clarity of regulatory timelines and strategy. Ensure transparency and excellence in evaluation, definition and execution of regulatory strategies.
- Ensure dossiers are produced and dispatched to assigned markets according to their defined filing plan and are submission ready.
- Ensure uncompromised compliance and embrace corporate culture.
- Understand local regulations and trends for assigned markets.
- Manage initial and post approval submissions for assigned markets.
- Enable initial and post approval strategy (including timelines) and execution in alignment and partnership with key to ensure a submission ready dossier.
- Ensure notifications of proposed regulatory changes and approvals are communicated to relevant stakeholders in a timely manner.
- Author local submission components as needed.
- Liaise with the manufacturing sites for obtaining supporting documents as needed.
- Ensure right first-time approvals - review submission packages against local requirements for consistency and completeness as needed.
- Co-ordinate with global strategists the receipt, distribution and response to regulatory queries from target countries, consistent with departmental procedures and including liaison with RRT members as needed to ensure that response targets are met.
- Support planning and monitoring activities, update timelines when necessary and communicate changes to the relevant partners.
- Communicate changes to regulatory requirements and update the appropriate system in a timely manner.
- Work in collaboration across the regulatory organization with stakeholders to deliver efficiencies in regulatory submissions and processes.
- Maintain systems and databases per internal SOPs and policies.
Education & Skills:
- Degree in any life sciences
- Knowledge of the European and Global regulatory environment and how this impacts regulatory strategy and implementation.
- Technically competent to understand CMC submissions, interpret and communicate BoH requirements, and identify potential regulatory risks.
- Knowledge of drug development practice, rules, regulations and guidelines.
- Experience in regulatory affairs or compliance preferably in human medicines - minimum 5 years of experience.
- Regulatory experience including knowledge of Europe submission product lifecycle management processes.
- Proven ability to manage Regulatory or drug development issues and consistently deliver to time, cost and quality standards.
- Proven ability to consistently deliver to time, cost and quality standards.
- Demonstrated experience of effective delivery in a matrix environment.
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: Natasha.Rollason@srgtalent.com or +441753 589673
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