Principal, Strategic Regulatory Affairs

An international pharmaceutical company is currently recruiting a Principal, Strategic Regulatory Affairs on a home-based capacity. The organisation offers a full range of consulting, development, and commercialisation services across 37 countries, with a global team of experts that have extensive experience across a broad range of therapeutic areas. This is an exciting opportunity to work with a dynamic and innovative establishment that accelerates the development of drugs and devices that save lives and improve patient's quality of life.

Job Responsibilities:

• Effectively manage/execute/oversee the preparation of regulatory submission documents demonstrated by a deep knowledge of applicable legislation and guidelines for submission to government agencies and continued client compliance.
• Facilitate submission approvals and amendments through leading communications (face to face meetings, teleconferences, etc.) and negotiations with client, government agencies, and project teams.
• Build positive working relationships with clients, and government agency contacts.
• Actively anticipate and develop initial or alternative regulatory strategies, consulting with other resources within the organisation as required.
• Provide clients with strategic advice in response to their queries, based on regulatory experience and area of expertise.
• Responsible for managing workflow including prioritising project objectives and establishing timeframes for projects with clients.
• Responsible for overseeing progress and completion of projects with project team members, ensuring timeframes and deadlines are met.
• Lead, participate in, and support project teams, and advise other departments on regulatory issues and strategies related to EU filings and maintenance activities across a broad range of product types.
• Effectively prioritise and complete multiple projects within established timeframes and within budget.
• Train, coach, and develop assigned individuals to build team expertise across various product types (preparation of files, regulatory strategy, client management, agency/client communications and project management).
• Enthusiastically monitors for new regulatory requirements and shares key findings.
• Lead and/or participate in the preparation of quotations for projects that may cross multiple service areas within the company and manage projects within budget, preparing change orders as needed.
• Publish and/or present at training seminars or lead workshops at industry conferences.
• Participate actively in other business-related projects (business opportunities, client specific issues etc.).

Skills and Requirements:

• Bachelor's degree in a relevant discipline, preferably in a life sciences, or other healthcare field.
• Advanced degree (MSc., PhD., M.D., Pharm.D., MBA) in the biological, medical, chemical or engineering field may be beneficial.
• Relevant experience i.e. pharmaceutical, biologics, medical device with regulatory experience in the local environment (Europe).
• Certification in regulatory affairs (RAC) or post-secondary institution beneficial.
• Thorough working knowledge of local and global Health Authority regulations, guidelines, policies, GCP and GxP, ICH Guidelines.
• Through knowledge of budgetary and financial management (budget, development, time and cost, forecasting, revenue, margin, profit and loss, invoicing, etc.).
• Knowledge of business development process.
• Shown ability to understand and communicate corporate policies and procedures.
• Relevant experience in any Therapeutic Area will be considered; experience in Oncology is considered advantageous.
• Experience supporting business development activities and people management an asset.
• Experience presenting at applicable industry conferences and/or publications in regulatory affairs.
• 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 with computer skills, such as MS Office.

To Apply:

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 Alex Czuprynski at +44 203 869 2329 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.

Proclinical Staffing is an equal opportunity employer.

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