Regulatory Project Manager (Chemist, Manufacturing and Controls) - Multiple Opportunities

Location
Brentford (City/Town), London (Greater)
Salary
£Competitive
Posted
08 Apr 2021
Closes
30 Apr 2021
Ref
285068
Contract Type
Permanent

We are seeking a number of highly motivated Regulatory Affairs professional to join our CMC (Chemistry, Manufacturing and Controls) Regulatory Affairs Group. Within Global Regulatory Affairs, the CMC organisation provides regulatory leadership to CMC teams encompassing Pharma Supply Chain (PSC), Technical and Quality representatives and Local Operating Companies to enable an uninterrupted supply of our medicines to patients. Our work spans all formulation types and markets for marketed small molecules.

We currently have a number of excellent opportunities to work on exciting projects as well as influence and shape new ways of working. As Regulatory Project Manager (CMC), you will be responsible for the provision of CMC support to a defined portfolio of marketed drug substances and products (small molecules) for global markets. This is an interesting and fast paced role which will provide opportunity for you to use and develop your CMC technical skills and regulatory knowledge for all regulatory active countries.

Key responsibilities include maintenance of the global regulatory information for assigned products by leading CMC Regulatory Matrix teams and representing CMC in the cross-functional Regulatory Product Matrix teams. In delivering your objectives you will partner with the manufacturing organisation (both Technical and Quality) to provide strategic regulatory advice for change controls, develop regulatory strategies and plans (through to implementation), and lead authoring of the variation dossiers and responses to Regulatory Agency questions.

LOCATION - This role can be based at GSK House (Brentford, West London) or at the Research Triangle Park (RTP) (North Carolina, USA).

About You:

This role involves the development of regulatory strategy and implementation of changes to global processes across multiple locations and stakeholders from the Manufacturing business-units. The roles would suit a driven and motivated individual who has strong experience of working in a complex Regulatory environment. You will have excellent people skills and be able to work across boundaries. You will need to be open-minded, with excellent communication skills and have proven experience dealing with diverse stakeholder groups. You should be comfortable dealing with issues which may initially appear ambiguous or unclear and demonstrate an ability and willingness to help resolve complex problems as they arise.

Basic Qualifications

  • Degree Qualified in suitable discipline (eg; Pharmacy, Chemistry or related scientific discipline)
  • Relevant experiences and/or qualifications in regulatory oversite (in multiple counties).

When applying for this role, please use your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you provide in your CV will be used to assess your application.

Company Details:

At GSK, we're a company with a special purpose, to help people do more feel better and live longer. Realising our purpose starts with us. When we feel at our best, we perform at our best.

When you set out on your adventure at GSK, we make a deal. You commit to living GSK's values and expectations and performing against our Innovation, Performance and Trust priorities. And in return, GSK commits to providing the right environment for you to thrive. Put simply, it's about you being motivated to do your best work, in a place where you can be you, feel good and keep growing.

Together we build an environment where we can all thrive and focus on what matters most to each of us. It is only through the energy, dedication, drive and passion of all of us that we can be the very best for GSK, and importantly, for our patients and consumers.

As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

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