EMEA Regional Regulatory CMC – Specialist / Senior Specialist Job

Date: Jan 16, 2019

Location: Hoddesdon, ENG, GB

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Requisition ID: REG003898

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’s Regulatory Affairs division helps bring new medical advancements to the world by facilitating the communications and procedures that allow swift, organized compliance across regulatory agencies. As a team of energetic, results-driven individuals, we’re a global network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices, and solutions to the world on time, every time.

We have exciting opportunities for Senior Regulatory Specialists, Regulatory Affairs, International CMC EU/EMEA region, in the Vaccines/Biologics/Small Molecule space to join our team based in Hoddesdon, Hertfordshire.

As Senior Regulatory Specialists you will be proactively involved in MSD’s strategy to build strong and collaborative relationships with EU/EEMEA Regulatory Agencies and develop innovative, robust regional CMC strategies. Team members ensure communication and alignment of regional CMC strategy with global CMC strategy by developing strong partnerships with Global CMC Product Leads, MSD Country RA Affiliates, Regional Commercial and Operations (supply chain) and the Quality organisation. Our goals are to achieve high quality, right first time submissions, successful launches and reliable patient supplies throughout the product lifecycle. Each team member typically manages a portfolio of products, and adopts a lessons learned approach for regional EU/EEMEA submissions. All candidates will have a sound knowledge and direct regulatory experience of EU and/or at least one sub-region of the EEMEA countries and be aware of current regulatory policy hot topics relevant to the development, registration or maintenance of products in regional markets. Candidates may be required to travel to other MSD sites.
Responsibilities:
• For assigned product portfolio, supporting the EU/EEMEA RA CMC Leads who have primary responsibility to develop robust CMC regional regulatory strategies for new marketing applications, Scientific Advice and post-approval changes, as appropriate.
• Working collaboratively with Global CMC RA Product Leads, the team will ensure right first time submissions, high approval rates, on target launches and successful implementation to maintain patient supplies throughout the lifecycle.
• Ensure that the regional CMC regulatory strategy is aligned with the global regulatory strategy, Therapeutic Area portfolio, commercial and operational strategies and the Target Product Profile issues impacting product approval, launch or patient supplies will be appropriately escalated to CMC Regulatory Affairs Management.
• Support MSD Country RA affiliate interactions with their local Regulatory Agencies to facilitate Scientific Advice and the prompt review and approval of submissions (as CMC content subject matter expert).
• Act as Regulatory CMC SME in regional post approval requirements and maintain/update the regulatory intelligence repository for Regional markets including communicating proactively with Global CMC Product Leads on regional registration requirements, new legislation and guidance and providing timely update of the CMC change management systems to support right first time submissions.
• Ensure high quality and timely responses to Regulatory Agency questions in Regional markets and fulfillment of regulatory commitments to Regulatory Agency deadlines.
• Support product compliance by ensuring local registrations and lifecycle management align with product manufacturing details.
• Drive continuous process improvement activities within the organization and participate in forums to ensure efficient processes and best practice.
• Influence CMC initiatives by internal and external engagement including trade associations and regulators to pursue priority advocacy plans impacting the business.
Qualifications

Minimum Qualifications
• Bachelor’s or Master’s Degree in chemistry, pharmacy, biology or a related science.
• At least five (5) years of relevant regulatory CMC experience (covering at least one sub-region of the EU/EEMEA countries). Additional prior experience in the pharmaceutical/device industry including manufacturing, testing, research; or licensure of products would be an advantage.
• Direct Health Authority experience would be an advantage.
• Knowledge of current ICH and local Regulatory Agency legislation and guidance and current hot topics related to pharmaceutical, biological and/or vaccine products.
• Ability to communicate effectively in English (written and verbally proficient).
• Ability to influence and a keen eye for detail.
• Ability to work well under pressure independently and collaboratively in a team.
• Additional qualifications such as PhD degree and language skills are an advantage but not essential.


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.

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.



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Job: Regulatory Affairs - CMC
Other Locations:
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings: 5
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


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