A well-known international pharmaceutical company with sites around the globe is looking to hire a Regulatory Strategist. The company specialises in developing and producing medicines and vaccines for a wide range of therapeutic areas including oncology, cardiology and immunology.
- 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.
- 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.
- 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 ensuring 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, and 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.
- Ensure training completion as per the assigned curriculum - a thorough understanding and application of GRA procedures.
- Contribute to local and regional regulatory initiatives promoting a culture aligned with the company's values and which supports compliance and innovation * Assist in ensuring internal regulatory processes and procedures are well documented.
- Identify and support efficiencies across the region through achieving consistency in initial and post approval strategies and its execution.
Skills and Requirements
- Bachelor's degree or equivalent (i.e. degree in Chemistry, Pharmacy, or a related life sciences).
- MSc, MBA or PhD may be an advantage.
- Prior experience in the pharmaceutical or related industry in Regulatory Affairs, Conformance or Compliance.
- Strong knowledge/background of EU regulatory procedures and requirements.
- 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.
- A minimum of 5 years of experience in regulatory affairs or compliance, preferably in human medicines.
- 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. Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency in computer skills, such as MS Office.
- Fluent in English - written and spoken communication skills.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Elise Stewart at 0207 440 0633 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.