Regulatory Project Manager (Fixed term contract 1 year), Open to flexible working
2 days left
- Contract Type
- Contract - interim/fixed term
GlaxoSmithKline (GSK) is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to create a platform for the delivery of strong growth in a rapidly changing healthcare market. Our mission is to improve the quality of human life by enabling people to do more, feel better and live longer.
In this role you will be responsible for the regulatory management of a portfolio of products across the product lifecycle and you will be the primary interface with the local regulatory authorities. You will also be involved in proactive leadership in defining and implementing effective regulatory strategies and influencing as needed to reflect business needs and responsible for assigned non-product activities of significance to the department /company. These may be of a complex nature.
Key Responsibilities include, but are not limited to:
- Responsible for the regulatory management (delivery and maintenance) of clinical assets and MAs for a portfolio of products for Ireland and UK
- Is the primary interface with the local regulatory authorities
- Ensure product information is compliant with MA. Ensures that GSK product Summary of Product Characteristics (SPCs) and Patient Information Leaflets (PILs)/ labeling are compliant with MA and with regulatory requirements
- Co-ordinates national input into responses to regulatory questions and regulatory commitments, ensuring these are in alignment with regulatory requirements and agreed strategy and timelines.
- Responsible for the local management of product registration documents in regulatory databases and repositories.
- Manage regulatory agency correspondence in accordance with company procedures
- Notify to Regulatory agencies product quality and safety issues in an expeditious manner in accordance with company procedures
- Completes Marketing Authorization Holder (MAH) review of Periodic Quality Reviews for all registered products in responsible portfolio for which GSK Ireland is MAH
- Effective planning of regulatory activities for portfolio
- Provides considered regulatory advice, leadership and expertise to brand teams and to other regulatory and cross functional groups.
- Co-ordinates meetings with regulatory authorities and plays a key role in these interactions
- Builds and maintains effective relationships with (not limited to) internal regulatory, medical, commercial, supply chain and clinical groups.
- Takes a proactive lead and shows an ability to focus and identify key issues early and contribute fully to the development of solutions
Closing Date for Applications: Thursday 15th April 2021
Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.
During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.
We are looking for professionals with these required skills to achieve our goals:
- Graduate/PhD level or equivalent, with experience in the pharmaceutical industry, including regulatory experience.
- In depth understanding and practical experience of national or/and EU regulations, guidelines and working practices and of the regulatory issues relevant to the portfolio.
- Knowledge of drug development process and regulatory affairs,
- Knowledge of the commercial and medical issues pertaining to the assigned portfolio, including an awareness of competitor products and activities
- Ability to work in a complex environment
- Good interpersonal and influencing skills
If you have the following characteristics, it would be a plus:
- Understands the impact of the regulatory environment and proposed changes which are likely to impact the business in the medium term
- Can define regulatory strategy
- Has an in-depth understanding of regulatory governance, medical and safety
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being.
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness.
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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