Senior Manager, CMC Vaccines Mature Products, Regulatory Affairs

工作内容

Site Name: Belgium-Wavre, USA - Maryland - Rockville, USA - Pennsylvania - Upper Providence

Posted Date: Oct 11 2021

We currently have an opening for an experienced CMC professional and are looking for a Senior Manager Regulatory Affirs, CMC Vaccines for Mature Projects.

Key Responsibilities

• You drive the CMC strategy, coordinates the timely preparation and authors, as needed, technical (CMC) regulatory documents to support development and registration of new vaccines or lifecycle activities and maintenance of registered vaccines, in accordance with the applicable regulatory & scientific standards, and taking into account the evolving regulatory requirements.
• You provide regulatory advice and guidance to the Technical Development Team and/or Technical Life-Cycle Team (TLCT), Implementation Committee, Specification Review Committee, Technical Review Board, CMC Expert Panel, and provides regulatory support to their partners in R&D, Quality Control, Manufacturing, QA and Supply.  Ensures adequate interaction and partnership with the Global Regulatory Lead’s team in order to define proper regulatory CMC filing strategy.
• You lead CMC Regulatory discussions during interactions with Worldwide regulatory authorities. 
• You ensure, in a continuous improvement mindset, regulatory compliance is maintained and shares best-practices and learnings within the CMC Regulatory teams and other impacted functions. 
• You engage and lead CMC Subject Matter Expert activities, both internally (for increased compliance, harmonisation and efficiency) and externally (external advocacy and shaping the regulatory environment). He/She, in a continuous improvement mindset, will ensure regulatory compliance is maintained and share best-practices and learnings within the CMC Regulatory teams.
• You mentor or train staff. You may have direct line or lead management responsibility.
• You may participate in corporate evaluation and provide CMC regulatory support/advice to in-licensing and divestment projects.
• You deliver CMC regulatory strategy to support major inspections (eg PAI’s) or quality incidents (PIRCs).
  

Why you?

Basic Qualifications

We are looking for professionals with these required skills to achieve our goals:

• Bachelor’s degree in Sciences or Medical Sciences with relevant experience
• Detailed knowledge of drug development and manufacturing and supply processes and may have a specialized area of expertise.
• Detailed working knowledge of complex worldwide CMC regulatory requirements and demonstrated ability to influence the global internal/external regulatory environment.
• Proven project management and multi-tasking skills.
• High ability to manage and direct multiple projects/teams
• Track record of effective influencing and negotiating with regulatory agencies, industry bodies, and personnel in a variety of settings
• Demonstrated ability to handle complex global CMC issues through continuous change and improvement.
• Strong communication and influencing skills
• Fluent in English
  

Preferred Qualifications

If you have the following characteristics, it would be a plus:

• Master’s degree or above in Chemistry, pharmacy, biological or closely related science advanced degree.
• Regulatory Affairs Certification (e.g. RAPS).
• Significant experience in Pharmaceutical industry or Research organizations, established in Regulatory Affairs and with demonstrated experience of team leadership
• Continued professional growth in global regulatory affairs including communication of evolving/emerging trends and policies. Has identified opportunities to further educate colleagues and formulate approaches to most effectively meet new requirements.
• Identified as CMC Regulatory expert in a specific subject area.
• Highly developed interpersonal, presentation and communication skills.
• Proven experience in supervising and training staff within an organisation
• Li-GSK
  

VxRD*

Why GSK?

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 in a culture of Innovation, Performance and Trust.

Patient-focused Research and Development (R&D) is the heart of our business. Our R&D department seeks to discover and develop new vaccines, to protect against diseases where vaccines are not yet available and to improve on those vaccines that already exist. Part of our R&D programme targets diseases particularly prevalent in the developing world, including the World Health Organisation’s three priority diseases - HIV/AIDS, tuberculosis and malaria. Research into candidate vaccines for other diseases of the developing world, such as dengue are at an earlier stage of development.

When it comes to developing the vaccines of the future, we’re looking for real experts in their respective fields who are interested in working in the stimulating environment of an international healthcare company.

We emphasise the value of teamwork and we look for people ready to share our values of transparency, respect, integrity and patient focus.

If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.

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