- Today's career recruitment can be quite competing, that's why you need to do the job properly in fact it is not really a hard course of action. will give you chance to undertake it so that you could help to make the right selection with much better strategy to acquire rapid as well as greater effect. This way you'll get better probability and also more secure reside down the road. GlaxoSmithKline is one of the corporations you can confidence to give family and friends ideal along with better live sometime soon. Subscribing to the corporation can make an individual capable of accomplish the goal less difficult along with help to make the desire come true.

To create the business imaginative and prescient vision as well as quest happens accurate; GlaxoSmithKline will be available with regard to new position while Position as Regulatory Manager - Biopharm CMC Regulatory Affairs Companies GlaxoSmithKline in United, PA in January 2018 within United, PA originate from January 2018. Everyone who's thinking about answering this specific empty, you should take part in this kind of Position as Regulatory Manager - Biopharm CMC Regulatory Affairs Companies GlaxoSmithKline in United, PA in January 2018 January 2018 recruitment throughout United, PA. It truly is advised for many members to arrange all needed needs with this career recruitment process, because practice requires that you allow suitable specification that the company desires just for this situation. If you think you are the one that could fill up the options, you can attempt to learn more information about Position as Regulatory Manager - Biopharm CMC Regulatory Affairs Companies GlaxoSmithKline in United, PA in January 2018 January 2018 in United, PA below.


Regulatory Manager - Biopharm CMC Regulatory Affairs

Company GlaxoSmithKline
Location United, PA
Update 4 Day ago
• BSc in life sciences or equivalent qualification/experience.
• 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.

Preferred qualifications:
• 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.

About You:
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.

About GSK:
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:

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.


Contact information:
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.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.