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Director, EU Regulatory Affairs, International CMC, Vaccines/Biologics Job

Date: Nov 4, 2017

Location: Hoddesdon, ENG, GB

Company: MSD

Requisition ID: REG002424

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 an exciting opportunity for a Director, EU Regulatory Affairs, International CMC, Vaccines/Biologics to join our team based primarily in either Hoddesdon, Hertfordshire and also other EU locations.

The Director, EU Regulatory Affairs, International CMC Vaccines/Biologics will develop and execute EU/EEMEA regional CMC strategy for pipeline and marketed vaccines and biotechnology products. Today, MSD has more than 50 prescription products in various therapeutic areas, such as cardiovascular disease, respiratory disease, oncology, neuroscience, infectious diseases, immunology and women's health. Vaccines are one of the greatest public health stories in history. MSD and its legacy companies have been discovering and developing vaccines for more than a century. Our unique vaccines have helped prevent a number of diseases, including ones never thought preventable. Today, we remain dedicated to the complex business of researching and producing vaccines and biotech/biotechnology products. Our marketed product portfolio and pipeline is diverse including small and large molecules, vaccines, a variety of dosage forms and drug-device combination products which offer exciting opportunities and challenges for regulatory CMC professionals.
Position Overview:

The Director, EU Regulatory Affairs, International CMC for Vaccines/Biologics will report to the Head, Regulatory Affairs, CMC and will be responsible for leading strategy development and execution of European region CMC life-cycle submissions as well as new product registrations for MSD Vaccines/Biologic products. It will ensure a focus on local needs of EMEA Country Regulatory Affairs (RA) teams and the needs of HQ CMC teams for these products. The position will be part of the MSD International CMC EU/EEMEA Regional hub. This role will be preferentially based in the MSD UK offices in London or Hoddesdon. Flexibility in location in Europe is possible for suitable candidates.

The International CMC Regional Hub is a key component of MSD’s strategy to build regional CMC regulatory knowledge and effective local relationships with MSD country RA offices, in order to deliver appropriate regulatory strategies, deliver right first time regulatory submissions, and support ongoing conformance of MSD’s manufacturing practices with the registered product details.

• For EU Vaccines/Biologics, the Lead will have primary responsibility to develop robust and well-planned CMC regulatory strategies for the management of post-approval technical changes and for the initial EU registration of new MSD Vaccines.
• In coordination with global CMC Regulatory Product Leads, the EU Vaccines Lead will develop and execute regulatory strategy for Vaccines/Biologic product lifecycle submissions in the EU/EEMEA regional markets, for management of CMC changes originating at manufacturing sites or affiliates, by maximizing submission efficiency and quality to ensure right first time and a high rate of submission approvals by Health Authorities.
• The Lead will be the primary regulatory (CMC) point of contact for the Regional/Affiliate DRAs and as such he/she will work closely with them and the regional Supply Chain teams as well as with the HQ CMC product leaders and all parts of the MSD Regulatory network.
• Act as subject matter expert in EU/EEMEA Vaccines/Biologic product CMC regulatory requirements post approval submissions and maintain the regulatory intelligence repository for regional markets under responsibility. Communicate proactively with HQ CMC staff on Vaccines registration requirements.
• For EU/EEMEA Vaccines products, participate and influence the CMC strategy by engagement with industry forums and BoH to pursue high priority advocacy plans.
• Drive continuous improvement activities within organization and excellent partnership within company wide CMC and international partners to ensure efficient processes and best practices.
• Support the company’s Product Conformance of all products in the region by ensuring local registrations and lifecycle management align with product manufacturing details.
• Ensure timely responses to Health Authority questions resulting from lifecycle submissions in regional markets under responsibility.
• Coordinate strategic planning with Regional Supply Chain and Affiliate DRAs for change management alignment and early visibility/communication/planning of changes impacting markets in the region.
• Manage tracking of Health Authority commitments as result of license/dossier approval and ensure commitment due dates are met.
• Ensure timely update of the CMC change management electronic systems, using the regulatory information provided from the submission/approval externally by a Health Authority, or internally by the appropriate functional area.
• Upon request, support country DRA interactions with regulatory authorities to facilitate the prompt review and approval of submissions (as CMC content Subject Matter Expert).
• The candidate may be required to travel to other company sites on a periodic basis.


Minimum Qualifications
• BSc. in a biological science, engineering, or a related field (or equivalent) (advanced degree preferred). Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry.
• At least 10 years of relevant experience, including biological/pharmaceutical research; manufacturing, testing, or licensure of biological products; or related fields.
• The candidate will have strong experience in Regulatory Affairs for the EU/EEMEA regional markets, with a focus on CMC requirements for Vaccines or Biologic products, development, manufacturing and/or quality assurance.
• Must have a proven ability to communicate effectively in both a written and verbal format. The candidate must be proficient in English; additional language skills are a plus.
• Ability to influence and work both independently and collaboratively in a team structure.
• Proven ability to work well under pressure

Additional qualifications such as PhD degree and language skills are an advantage.
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.


Job: Regulatory Affairs - CMC
Other Locations:
Employee Status: Regular
Travel: Yes, 20 % of the Time
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD

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