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Senior Manager, CMC Vaccines Development Projects

Job in Wavre - Belgium
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Company: GSK
Full Time position
Listed on 2021-04-22
Job specializations:
  • Science
  • Pharmaceutical
    Pharmaceutical Manufacturing, Pharmaceutical QA, Pharmaceutical Sciences
Job Description & How to Apply Below
We currently have an opening for an experienced CMC professional and are looking for a Senior Manager, CMC Vaccines Development 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
Note that applications are not being accepted from your jurisdiction for this job currently via this jobsite. Candidate preferences are the decision of the Employer or Recruiting Agent, and are controlled by them alone.
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