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EMEA Regional Regulatory CMC – Senior Specialist Job

Date: Sep 7, 2017

Location: Dublin, IE

Company: MSD

EMEA Regional Regulatory CMC – Senior Specialist-REG002976

Description

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.

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. MSD and its legacy companies have been discovering and developing vaccines for more than a century and 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, manufacturing and licensing 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.

These key positions are part of the RA CMC UK/Ireland Regional Centre of Excellence which is a key component of MSD’s strategy to build strong and proactive 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 to enable 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 to build a centre of excellence 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 our 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 either independently or collaboratively in a team.

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

Job: Regulatory Affairs - CMC Job Title:EMEA Regional Regulatory CMC – Senior Specialist

Primary Location: EMEA-Ireland-Leinster-Dublin

Employee Status: Regular

Travel: Yes, 10 % of the Time

Number of Openings: 3

Company Trade Name:MSD


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