Regulatory Affairs Manager

Regulatory Affairs Manager

Mindlance Clinical has been providing scientific and clinical research staffing and outsourcing services to leading pharmaceuticals, biotechnology, medical devices and CROs for over a decade. Due to the ever changing complexities associated with supporting a successful study from the inception of drug development planning to regulatory submissions to market, we understand it is the talent and quality people that make the difference. With the additional emphasis placed on time-to-market and reduction in the drug development life cycle, clinical support becomes even more crucial to the success of the study and ultimately the ability to commercialize the product. Our Clinical recruitment team has over 40 years combined clinical/scientific recruitment expertise to understand your hiring needs for clinical trials.

Job Description

Job Position: Global Regulatory Affairs – Strategy Manager

Duration: Fulltime Permanent

Manager, Global Regulatory Strategy (GRS) will be a forward-facing role, representing GRS on project teams and communicating strategic options, issues and risks to a broad range of Stakeholders in an end-to-end pharmaceutical business model (R&D through commercial).

The candidate will have the opportunity to research, develop and implement regulatory strategies to facilitate global approval of new medicinal products. There will be an opportunity to contribute to a New Drug Application (NDA) submission, as well as other global registration submissions for a New Chemical Entity (NCE).

• The candidate in this position will be a key contributor to the planning, execution and assessment of product life cycle management activities and strategies - all with a global focus. The candidate will have the opportunity to lead interactions with the US Food and Drug Administration. Opportunity for interactions with ex-US Health Authorities is also possible within this role.

• The candidate will work with autonomy to provide advice on US regulatory clinical trial and marketing authorization requirements to the Regulatory Sub-team and the International Project Team (IPT). In addition, the candidate will have ownership of the preparation and submission of documents to Regulatory Authorities (Meeting Requests, Annual Reports, and Protocol Amendments etc.). Responsibilities include but are not limited to: 1. Organizing resources and processes across multiple teams / functions to develop and deliver complete regulatory submissions within agreed time frames. Providing regulatory support to project teams for assigned projects 2. Developing and implementing regulatory strategy for the assigned projects. Leading issue resolution of regulatory risks by identifying, escalating and monitoring issues 3. Contributing to the planning, execution, and assessment of product life cycle management activities and strategies 4. Contributing to, and implementing strategy for interactions and negotiations with health authorities. May autonomously handle routine communications with regulatory authorities 5. Contributing to the department-wide work-stream/initiatives, as assigned

Qualifications

• Four (4) years of broad pharmaceutical industry experience, including 2 years' experience of new drug regulated product strategy and submissions.
• Ability to assume accountability for a project goal/objective
• Ability to distill and succinctly communicate strategic options, issues and risks to a broad range of Stakeholders in an end-to-end pharmaceutical business model (R&D through commercial).
• Candidate must be adept at tailoring and translating key messages based on Stakeholder need and issue at hand. Stakeholders will be both internal and external (such as Health Authorities).
• Candidate must be adept at leading team discussion to resolve and reach agreement on project issues.
• Candidate should be comfortable working independently to create Health Authority correspondence (including request for Health Authority consultations), and attending specific project team meetings (such as Clinical Study Team Meetings) as the Regulatory Affairs Representative and providing guidance to project teams on all areas of pharmaceutical drug development (ICH, 21CFR).
• A working knowledge of relevant drug laws, regulations and guidance's/guidelines is highly desirable.
• Global experience is a plus
• Candidate will work with autonomy, however must be comfortable escalating strategic or operational issues to the hiring manager as appropriate.

Additional Information

All your information will be kept confidential according to EEO guidelines.

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