Senior Regulatory Affairs Consultant - NEW ROLE- Do you have European Product launch experience?
- Experience Level
- Senior Management
Role: Senior Regulatory Affairs Consultant ( Senior Manager Level role equivalent )
Some remote working is offered.
The role holder may have responsibility for managing standalone projects, including negotiating deadlines and expectations with the client on a day to day basis.
As well as these responsibilities, the Senior Consultant will also be expected to act as an ambassador of the Company, contributing to journals, and networking actively with peers as well as potential clients while presenting a strong technical and commercial understanding of the industry.
B. Key Accountabilities and Duties
The Senior Consultant is a source of regulatory expertise in the development, registration and post-licensing activities of pharmaceutical products or other Health products. Within the global regulatory team, the role actively provides tailored consultancy services for a range of clients, from ad hoc advice to long term partnerships.
Technical duties will include but are not limited to:
• Act as a subject matter expert with regards to a wide range of regulatory projects, including but not limited to:
- Development and regulatory strategy (e.g. scientific Advice, ODD, PIP, CTA);
- Registration (e.g. project management of submission, audit, responses to questions,
writing of CTD documents MAA/NDA);
- Post MAA (e.g. preparation and submission of variations, advice on classification and
documentation required, MA holder transfers, renewals, launch activities and
coordination of local partners);
- Writing of regulatory documents;
- Interaction with agencies and partners.
Ensure high quality and on time delivery of consulting services to clients.
As part of the role activities, expertise to all teams and contribute to various projects.
Contribute to the effective functioning and to the business growth
Non-Technical duties include, but are not limited to:
• Act as a key representative on behalf of company ensuring that client expectations are managed in line with the business needs and that all communications are of an excellent
professional standard. Demonstrates a sound understanding of both capacity and the issues and challenges faced by the client.
• Demonstrate consistently excellent presentation skills by contributing if required to professional presentations which address the needs to the target audience, and clearly and concisely translate the features of the services of in order to maximise commercial potential.
• Demonstrate ability to balance the needs of the business against service levels required by client by maintaining regular contact, and developing rapport with client. Actively seeks out feedback regularly from client and produces relevant performance reporting with regards to client service levels
• Maintain an excellent understanding of services, and constantly seek to improve this, contributing new ideas as appropriate, and communicating appropriately to key personnel within Regulatory and Commercial.
• Demonstrate a sound understanding of Quality Management System processes and procedures ensuring that all work undertaken follows guidelines set out by the business.
• Prepare regulatory papers for journals as and when required. Conduct thorough investigations and second source information as appropriate.
Network with peers outside the business in similar sectors, for example SPIN Groups, TOPRA
Assist in the training of Consultants and Associates, liaising with the Senior Manager as
• Establish and maintain personal log of training and skills development with regards to international legislation, guidelines and client practices. In addition log sources consulted in the research process so that active learning and development can take place.
• Remain committed to self-improvement by conducting self-appraisals after all relevant unit tasks, and assess strengths and weaknesses and address these accordingly. Demonstrate a commitment to improvement by maintaining and developing current skill set.
• Maintain consistent communication with the commercial team, ensuring it is aware of all
commercial opportunities and changes within projects.
Key Behavioral Indicators
• Demonstrates subject matter expertise by being able to coach and train others to improve performance, by being perceived as an expert. Is consulted with regarding specialist knowledge from inside and outside team as well as contributing to knowledge base of professional discipline outside of the business and within the sector, cascading relevant market/sector developments. Anticipates risks and issues, networking with peers outside the business in similar sectors and translating industry and technological changes into commercial opportunities. Remain committed to self-improvement by conducting
self-appraisals after all relevant external meetings and assess strengths and weaknesses and address these accordingly. Demonstrate a commitment to improvement by maintaining and developing current skill set.
• Demonstrates a high level of analytical skill; leverages financial knowledge; keeps up to date with market trends and professional expertise; exercises sound judgment and decision making.
• Demonstrates sound decision making identifying and understanding issues, problems and opportunities; comparing data from different sources to draw conclusions; using effective approaches for choosing a course of action or developing appropriate solutions.
• Demonstrates an ability to employ a variety of project management techniques, tools, and methodologies, able to utilise tasks to achieve not just one outcome but several positive outcomes (i.e. training and coaching) and actively monitors and reports on self and team progress and communicates to peer group and team appropriately (e.g. resource utilisation and tracking projects with regards to targets and milestones, and margins).
• Demonstrates sound business acumen by possessing an excellent understanding of core business, products and services; appreciates the added value that our products and services bring to the client, recognises own role and how that contributes to commercial success, talks confidently about Company aims, objectives and strategy and knows how own objectives are linked to the team and how team objectives link to the overall business strategy.
• Demonstrates effective team working by positively contributing ideas and solutions, shares own skills and knowledge, builds rapport and develops good relationships with colleagues in a cross functional and diverse environment. Chairs meetings in a constructive, direct and organised way, makes team work fun, takes a positive attitude to tough challenges and consults with others to engage them in the planning process.
• Demonstrates effective negotiation skills by speaking confidently with senior colleagues, maintaining good personal credibility and convincing others, communicates regularly and appropriately when required at all levels. Demonstrates integrity and conviction in own views, setting clear and achievable negotiating objectives and identifies areas of compromise and fallback positions, adjusts quickly to changing circumstances and information. Compromises without losing sight of key objectives, seeking a win-win situation in all negotiations and discussions and produces well prepared communications, concise and persuasive arguments identifying key issues, options and proposing way ahead.
• Demonstrates excellent organisation skills, including a methodical approach to work with excellent prioritization and time management with multiple tasks and activities, is deadline orientated, and ensures that work is completed efficiently in a fast-paced environment.
Demonstrates a sound understanding of Quality Management System processes and procedures ensuring that all work undertaken follows guidelines set out by the business.
Demonstrates a customer focused attitude and ability to build trusted working relationships. Able to work with complete confidentially and discretion, giving confidence to colleagues and clients alike. Has a consultative approach; strong customer orientation and engagement; implements services to meet customers’ and organization’s needs. Is proactive to client needs in a changing environment and takes action on customer feedback resolving difficult issues in a timely manner.
Has a respect for administration processes, is able to explain, manage and gain agreement to manage workload, demonstrates capability in managing changing priorities as projects progress without losing sight of budgets and resources, sees the value of planning, acts proactively in the work environment, contains, manages and delegates reactive situations effectively, develops realistic and flexible contingency plans which can be utilised effectively when required.
Essential Skills and Abilities
Microsoft Office trained in Word, Outlook, PowerPoint, Excel
Proven ability to work across a wide spectrum of activities.
Extensive, proven regulatory experience gained within a fast-paced environment
Good experience with project management tools and methodologies
Excellent written and verbal communication skills across multiple levels of an organisation.
Established relationships and proven negotiation skills with management, colleagues and
Excellent scientific writing skills
Very good level in English (Native English speaker or fluent in English)
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