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Regulatory Manager - Biopharm CMC Regulatory AffairsCompany GlaxoSmithKline
Location United, PA
Update 7 Day ago
• CMC Regulatory Affairs or CMC development experience in Biopharmaceuticals or Cell & Gene Therapy gained with direct involvement in regulatory submission preparation.
• Experience of authoring or preparing and submitting CMC content for clinical trial applications and/or marketing applications.
• Strong verbal and written communication skills with good attention to detail.
• Capable of working and making decisions independently.
• Successful track record of delivering CMC strategies and submissions content that comply with global regulatory requirements.
• Excellent team working abilities and effective influencing skills.
• Good time management skills with the ability to effectively plan, prioritise and co-ordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines.
• Ability to find innovative solutions to complex problems and involvement in continuous improvement initiatives.
The successful candidate will:
• Represent Biopharmaceutical CMC Regulatory Affairs on regulatory networks and matrix teams, providing regulatory advice and guidance to product development teams and the global manufacturing organisation.
• Be responsible for the global CMC regulatory activities for projects teams, setting the strategy for CMC regulatory content of clinical trial applications and marketing applications.
• Understand, interpret and advise on regulations, guidelines, procedures and policies relating to development, registration and manufacture of Biopharmaceutical and/or Cell & Gene Therapy products.
• Support license maintenance, change control requests, and post-approval submissions, ensuring delivery to agreed timelines.
• Maintain high quality standards and a continuous improvement and innovative approach in responding to the evolving regulatory environment.
• Communicates across the company to influence CMC project and policy issues that are aligned with business needs.
This role would suit a self-motivated individual who can demonstrate initiative, high learning agility and adaptability. You will be resilient and calm under pressure, with strong people skills and a proven ability to influence people to achieve objectives and drive performance. You will have a strong continuous improvement mindset.
The role would also suit an individual who has experience of working in a cross-functional, global supply organisation. During the application process, we are looking to see that applicants have a clear understanding of the complexities and importance of supporting production within a pharmaceutical manufacturing process.
GSK is a science-led global healthcare company that researches and develops a broad range of innovative medicines and brands. Our products are used by millions of people around the world, helping them to do more, feel better and live longer. Employing over 100,000 people globally, we have 71 manufacturing sites around the world. For more information on GSK please refer to our website: www.gsk.com
This role can be based in or Upper Merion, Pennsylvania, USA or Ware, Hertfordshire, UK this role requires you to interact across all the functions of Global Regulatory Affairs to ensure global approaches and strong connectivity.
CLOSING DATE for applications: Friday 12th October (Close of Business) 2017.
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.
You may apply for this position online by selecting the Apply now button.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, 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.
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