Senior Associate Global Regulatory Affairs

Job Summary:

Senior Associate Global Regulatory Affairs - ASAP to send of year
Requirements:

Title: Senior Associate Global Regulatory Affairs

Location: Buckinghamshire

The Regulatory Professional provides support to the Regional Strategic Implementation Leader (RSIL) and Regulatory Regional Leader (RRL) for regulatory activities for products in the assigned portfolio. Key responsibilities include the following:

1. Input in development, post-approval and life cycle management

Participates in Working groups to ensure timely regional and local input into product objectives, to align regions with CDT/global strategy.
Advises the Regulatory team on applicable regulatory requirements, project specific regulatory issues as assigned;
Develops an understanding of the regional regulatory environment, competitor intelligence and therapeutic area.

2. Interaction with the Regional groups and Local Operating Companies

Works with the regional staff and LOCs to support regional and local activities;
Assists in the preparation of meetings with Regulatory Agencies.

3. Input in document and process development

Assists in the development of processes related to regulatory submissions;
Drafts and reviews document content (depending on level of regulatory knowledge/expertise);
Provides input to documentation to ensure they are in line with product strategy and thoroughly and accurately answers the questions being posed;
Tracks dates of submissions and Regulatory Agency responses.

4. Clinical Trial Applications (CTA)

Advises team on required documents in preparation of CTAs;
Provides operational support for the assembly and distribution of submissions ( e.g., Clinical trial applications for China, Health Authority Responses);
Ensures CTA submission packages are complete and available according to agreed timelines.

5. Marketing Authorization Applications

Provides regulatory support throughout registration process and life-cycle management (e.g. iCTDs, ACTDs, renewal applications, Health Authority Responses, site registrations and routine marketed product submissions including PSURs, RMPs);
Advises team on required documents in preparation of submissions as assigned;
Assists with timely registration dossier availability, ensures that all document components are in place on time, identifies and tracks critical path activities;
Compiles Module 1 for iCTDs to be dispatched to countries;
Manages and tracks the assembly of country-specific submission packages to the LOCs in accordance with agreed plans.

6. General

Responsible for the critical review of submission documents to ensure compliance with regulatory requirements;
Provides regulatory support for and appropriate follow-up to inspections, audits, litigation support and product complaints (depending on level of regulatory knowledge/expertise);
Serves as the Regulatory representative on specific multi-discipline teams;
Keeps abreast of current and pending approvals in specific therapeutic areas and is knowledgeable of laws, guidance and requirements related to those areas.

Principle responsibilities for the Regulatory Professional, include:

Supports all regulatory activities associated with the development, post-approval and life-cycle management for designated products. Provides regulatory support for products by interacting with project teams, LOCs and regional teams and supporting CTA and registration dossier related submissions as appropriate.
Provides other general support on an as-needed basis e.g. provides regulatory input and follow-up for inspections, audits, litigation support and products complaints (as appropriate)
Participates in the development of departmental processes and procedures.

Required Leadership Competencies:

Results consistently delivers results that meet or exceed expectations; makes the customer central to all thinking; keeps the focus on driving customer value
Analytical Thinking: Understanding a situation by breaking it apart into smaller pieces, or tracing the implications of a situation in a step-by-step way. Analytical Thinking includes organizing the parts of a problem, situation, etc., in a systematic way; making systematic comparisons of different features or aspects; or systematically breaking down multidimensional, complex problems or processes into component parts, and using several analytical techniques to assess several solutions and weigh the value of each
Communication: The ability and intent to effectively explain, describe or convey information orally or in writing to individuals and to a wide variety of large and small groups. Includes speaking with authority, confidence and conviction. Also includes using visual aids - e.g., charts, graphs - effectively, and responding effectively to questions
Concern for Quality and Order: An underlying drive to reduce uncertainty in the surrounding environment. It is expressed in such forms as monitoring and checking work or information, insisting on clarity of roles and functions, and putting systems and processes in place to meet information needs
Self Awareness has personal modesty and humility; willing to learn from others; patient, optimistic, flexible and adaptable
Intellectual Curiosity (GLP): Sees the possibilities; willing to experiment; cultivates new ideas; comfortable with ambiguity and uncertainty
Sense of Urgency (GLP): Proactively senses and responds to problems and opportunities; works to reduce "cycle" time; takes action when needed
Collaboration works well across functions and groups; builds team effectively; inspires followership; instills a global mindset; champions best practices