Senior Manager Gastrointestinal & Neuroscience
A leading and global pharmaceutical company is currently hiring a Senior Manager Gastrointestinal & Neuroscience. 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.
- Provides strategic and tactical regional regulatory advice and guidance to teams to achieve timely and efficient conduct of development programs and/or oversight of marketed product support, while maintaining full compliance with applicable regulatory requirements.
- Effectively communicates objective assessments of the likelihood of success of these regulatory strategies.
- Provides regulatory expertise and strategic focus for assigned development projects and /or marketed product life cycle management.
- 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.
- 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 in context of parallel consultation) in the Europe Union and European Economic Area for specific product(s).
- Helps the Lead of the regulatory working team for own region and represents region as needed at project team and ensures regional regulatory lifecycle management strategy and submission planning written and executed according to plan - or oversees if delegated to staff and/or 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.
- Where responsibility includes a marketed product, provides oversight to ensure regulatory compliance, including oversight of the product related data in the registration database.
- 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.
- May be called upon to support in due diligence for licensing opportunities, development and /or marketed product opportunities.
- Builds/strengthens external stakeholder (Regulatory Agency, external experts, industry organisations, etc) contacts/influence to support the company's strategic goals and objectives.
- Identifies regulatory requirements across area(s) of responsibility, and provides regulatory guidance, and expertise to global development team and /or Region in these areas.
- Identifies and proposes solutions to the management of resource gaps for areas of responsibility.
Skills and Requirements:
- 6+ years of pharmaceutical industry experience. This is inclusive of 4 years of regulatory experience.
- BS degree or equivalent in science; advanced degree preferred.
- Experience within the pharmaceutical industry including direct experience in regulatory affairs in development and /or post-marketing phases.
- Working knowledge of regulations and guidance's governing drugs and biologics in development, including post-marketing in the US and/or EU (relevant to role).
- A good understanding of basic regulatory requirements in emerging markets is a plus. Awareness of evidence requirements beyond the regulators (e.g. HTA bodies)
- Understands and interprets complex scientific issues and capability to relate to regulatory requirements and strategy.
- Proven regulatory submissions capability in a region (Europe, US, EM).
- 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.
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.