17 May

Manufacturing Site Cmc Associate Director Vacature bij Msd Haarlem

Manufacturing Site Cmc Associate Director
Haarlem NH
17 May, 2018 4 days ago

Msd Haarlem met spoed nodig onderstaande werk positie als de Manufacturing Site Cmc Associate Director. Lees deze personeelsadvertentie zorgvuldig alvorens het aanbrengen van. Er zijn enkele kwalificaties, ervaringen en vaardigheden eisen dat de werkgevers nodig hebben. Doet je carrière geschiedenis passen deze eisen? Ervoor begrijpen dat u de rol die je solliciteert en dat zorg ervoor dat het geschikt is met uw vaardigheden en kwalificaties te.

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Manufacturing Site Cmc Associate Director Vacature bij Msd Haarlem Vacatures Detail:

Role Description

The candidate will be part of MSD’s corporate Regulatory CMC organization and will act as the Regulatory CMC Lead within the (Harlem) manufacturing site. The establishment of site CMC is a key component of MSD’s strategy to build effective linkage of the CMC RA organization with the MMD.

The site CMC role will support the conformance of MSD’s products with the approved Marketing Authorisations and will support regulatory submission activities associated with the site. The CMC Associate Director will act as the key CMC liaison with the Site leadership.

Appointment to this position will be on local salary and benefits package.

Core function

– manage the interface between the Manufacturing site and Regulatory CMC to maintain product regulatory conformance. Specific responsibilities include:
– Ensuring that the information included in filings is aligned to plant information and supports future compliance and maintenance
– Ensuring that regulatory-impacting changes are correctly identified and assessed for regulatory impact. Work with other CMC teams to ensure that regulatory post-approval changes are prosecuted efficiently through to last market approval and implementation.
– Ensuring that regulatory information is correctly maintained, updated and interpreted, using MSD’s Regulatory Information systems and tools
– Working with site Quality, Technical and Supply chain functions to ensure that product is released in accordance with the relevant Global Marketing Authorisations

Other activities

– Co-ordinates submission component authoring (mainly for post-approval CMC changes) with site SMEs and CMC product leads. Co-ordinates responses to BoH questions on submissions. Sources and provides technical data and reports, ancillary submission documents to support regulatory submissions and BOH questions.
– Participates in major project teams where there will be significant regulatory impact, e.g. product transfer teams.
– Ensures that BOH commitments are captured in site commitment tracking and are fulfilled
– Supports BOH notifiable events and investigations
– Supports BOH inspections
– Drug Master File, Site Master File authoring / updates
Desired skills & experience

  • The candidate must possess a relevant Bachelor’s degree or higher in science, (e.g. pharmacy, chemistry, biotechnology, microbiology, biomedical sciences etc.) with a minimum of 5 years of experience in the pharmaceutical industry in a regulatory, compliance technical or quality role.
  • The candidate must have a minimum of 3 years’ experience in CMC Regulatory Affairs, ideally in a manufacturing site environment or in a Regulatory Agency.

    o Exceptional candidates without direct CMC experience will be considered where they possess a significant technical and scientific background and they have prior experience of significant engagement with Regulatory CMC projects and Regulatory Agencies
  • The candidate must have a good understanding of and experience working with a busy commercial manufacturing organization. He / she must be able to effectively manage the competing demands of site and corporate stakeholders.
  • He/she will demonstrate effective problem solving, understanding of regulatory strategies, excellent interpersonal skills, detail oriented, and able to prioritize multiple tasks.
  • Must have a proven ability to communicate effectively in both a written and verbal format.
  • Ability to influence and work both independently and collaboratively in a team structure.
  • Proven ability to work well under pressure.

About MSD
MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

MSD. Inventing for Life. For more information, visit our website: www.werkenbijmsd.nl

A good place to work
Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At MSD, we’re inventing for life.

For further information regarding this position, please contact Juliet McGillycuddy, Director Regulatory Affairs, phone +353214939839

If you are interested in this challenging role, you are requested to apply online by uploading your resume and application letter in English.

Search Firm Representatives Please Read Carefully:
MSD is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at MSD via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of MSD. No fee will be paid in the event the candidate is hired by MSD as a result of the referral or through other means.

Job: Regulatory Affairs - CMC

Primary Location: EMEA-Netherlands-NH-Haarlem

Employee Status: Regular

Travel: Yes, 20 % of the Time

Number of Openings: 1

Company Trade Name:MSD

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