Senior Manager Marketed Products
A worldwide and innovative pharmaceutical company is seeking to recruit for a Senior Manager, Marketed Products position. Specialising in multiple therapy areas, the company boasts a superb pipeline with products that include treatments for diabetes, cancer and asthma. Based in Switzerland, this is an exciting opportunity to bring expertise and skills to an established and in-demand company.
- Collaborates to define and develop regional strategies to maximise regulatory and patient access success to enable patient access to meaningful medicines in alignment with program objectives.
- Effectively communicates objective assessments of the likelihood of success of these regulatory strategies.
- Assists the Senior Director MP to help him/her provide strategic and tactical advice and guidance to teams to achieve timely and efficient conduct of development programs, while maintaining full compliance with applicable regulatory requirements.
- Provide regulatory expertise for multiple projects and/or one highly complex project for assigned development project of responsibility.
- May be called upon to attend internal leadership team meetings, as appropriate
- Monitors and informs on emerging trends, regulations and changes, with emphasis on those related to project areas and/ or region of responsibility enabling proactive approach and planning to future business requirements.
- For Europe based roles, primary EMA contact for project(s)/products of responsibility or can delegate to staff and/or vendor with oversight. Informs the business.
- Manages interactions with EMA and national health authorities (and HTAs jointly with value and access team in context of parallel consultation) in the Europe Union and European Economic Area for specific product(s).
- Helps to Lead the regulatory working team globally or for own region and represents as needed at project team and ensures global and/or regional regulatory lifecycle management strategy and submission planning written and executed according to plan - or oversees if delegated to vendor.
- Partner with the regional/LOC market access and LOC RA colleagues to understand market access and reimbursement topics and support opportunities to drive consolidated inputs into regional product development plans.
- For the project(s)/product(s) of responsibility, collaborates with Global and Regional colleagues for the authoring of global regulatory strategies and ensures own critical deliverables as agreed within the global regulatory strategy and planning.
- Accountable for working with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule within region (s) of responsibility (E.g. EMA submissions for Europe).
- Understands importance of regulatory documents for value and access discussions and partners with access functions to support access applications as needed.
- Identifies relevant regional regulatory requirements and provides regulatory guidance, and expertise to internal team on the assigned project(s) of responsibility.
- Authors and reviews regional regulatory strategies as well as executes day-to-day activities for projects or may delegates to vendor with oversight.
Skills and Requirements:
- A minimum of 8 years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 7/8 years regulatory and/or related experience.
- BSc degree or equivalent in science; advanced degree preferred.
- Considerable pharmaceutical industry experience. This is inclusive of thorough regulatory experience or a solid combination of regulatory and/or related experience in both development and /or post-marketing phases.
- Solid working knowledge of regulations and guidance's governing drugs and biologics in all phases of development, including post-marketing, in the US and/or EU (relevant to role).
- A good understanding of basic regulatory requirements in emerging markets preferred. Awareness of evidence requirements beyond the regulators (e.g. HTA bodies).
- Understands and interprets complex scientific issues across multiple projects as it relates to regulatory requirements and strategy.
- Preferred experience in managing major regulatory filing(s); and significant contributor to regulatory and/or development strategies.
- Generally strong in most and acceptable in all basic skill sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
- Generally strong in working well with others and within global teams; and acceptable at communicating with senior leadership.
- Generally strong leader who is effective manager and is able to bring working teams together for common objectives. Able to mentor and develop skills of team members.
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 Kelechi Dyke at 0203 854 0200 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.