We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex UK is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.
Manager/Senior Manager, Development Consulting and Scientific Affairs
We are currently looking for a Manager / Senior Manager, DCS to work in our UK Development Consulting and Scientific Affairs (DCS) team. Ideally candidates must have experience with pharma/biotech product development, working with the regulatory bodies, and the ability to provide both strategic consulting to clients in the all stages of innovative medicines development and support for milestone regulatory submissions and agency interactions. The successful candidate will bring with them a high level of ownership over their work, an enthusiastic attitude and a collaborative mindset to provide regulatory and development consulting solutions for pharmaceutical and biotech companies of all sizes.
- Support and/or lead project teams from client kick-off to final deliverable, contributing to and overseeing technical and regulatory activities
- Support project leads with any delegated responsibilities
- Research and recommend development and regulatory strategy, as well as navigating clients through the development process
- Assess scientific data, including technical and regulatory review of CMC, nonclinical, and clinical summaries for regulatory strategies and submissions
- Represent clients to the regulatory authorities including acting as the primary contact point and taking a leading role in teleconferences and face-to-face meetings with regulators
- Utilize project management skills to meet project objectives and milestones, including management of client expectations and deliverables and budget
- Anticipate problems before they arise in a project and implement risk mitigation steps as appropriate
- Identify scope changes in projects and manage or bring to project lead attention
- Employ and develop an awareness of the pharmaceutical industry and clients’ circumstances
- Interpret regulatory guidance documents and apply their meaning to client development strategies
- Provide recommendations on regulatory and development issues for clients
- Communicate with health authorities on behalf of clients in a clear and concise manner
- Structure and independently prepare complex final deliverables, with on-time delivery
- Review and edit work of others, providing constructive feedback
- Make effective presentations to client/sponsors and health authorities as appropriate
- Communicate with client and health authorities at the appropriate level of detail
- Establish a working relationship with the client according to the scope and nature of the project co-ordinating with other PharmaLex team members as required
- Work with client personnel to resolve issues/problems, responding to client requests in a timely manner
- Manage client relationship when there are changes in scope or the project plan
- Challenge strongly held client assumptions with well-researched justifications, as appropriate
- Maintain meaningful relationships with clients after project is completed, keeping PharmaLex business development apprised
- Actively seek out new client relationships/new business opportunities on behalf of PharmaLex
- Provide appropriate structure for team
- Provide timely and constructive feedback to team members
- Identify opportunities for follow-on / expansion of work within current projects
- Establish useful venues to take action on developing the opportunities into proposals
- Support selling efforts for obtaining work from new and existing clients.
- Bachelor’s degree in pharmacy, pharmaceutical regulatory affairs, medicine, chemistry or a life science discipline
- Ideally - ‘hands on’ regulatory affairs role and experience in a broad range of regulatory submission types with a thorough grasp of European regulatory requirements and an awareness of differing regional and national requirements
- Experience of participating in meetings with regulatory bodies
- Hands-on experience of preparing key regulatory submissions e.g. Scientific Advice, Orphan Drug applications, PIPs as well as contributing to CTD dossier components (directly or indirectly)
- Good organization, analytical, and problem-solving skills
- Autonomous, concentrated and high-quality work with attention to detail
- Ability to work in a team and experience in leading project teams
- Display solid ethics and fully comply with all regulatory, legal and industry codes of conduct
- Ability to navigate and be successful in a fast-paced environment while delivering high quality results
- Adaptable to changing plans when situations require it
- A willingness to accept new challenges, with appropriate support and mentoring
- Able to share learning/experience with other PharmaLex colleagues
- Sense of responsibility and accountability
- Ability to adapt under regularly changing conditions
- Very good command of English, written and verbal and excellent written and verbal communication skills, including effective and professional client-facing interactions.
- 25 days holiday, increasing with length of service plus BH
- 8% employer pension contribution
- Healthcare or Health cash plan
- The role can be based at any of our UK and European locations
- An opportunity to work within an organisation with a positive work/life balance environment
- Continuous development opportunities through knowledge and experience as well as training.
If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receiving your CV and a covering letter, explaining how you meet or exceed the specifications for this position, including your salary expectations on-line.
To apply, please use the "apply now" button below
Agencies only by prior agreement for the specific job opportunity.