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Executive Director (Distinguished Scientist) Regulatory Affairs EuropeTherapeutic Area Lead, Job

Date: Oct 29, 2017

Location: London, ENG, GB

Company: MSD

Requisition ID: REG002919

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.


 


We have a newly created opportunity for an Executive Director, Regulatory Affairs Europe, General Medicine to join our expanding team, based in Kings’ Cross London, U.K.

The Executive Director will report to the Associate VP, Regulatory Affairs and is responsible for developing EU product regulatory strategy for General Medicine, with the aim to optimize label and obtain shortest time to approval by regulatory agencies. Our General Medicine portfolio entails new registration and maintenance products in Neuroscience, Womens’ Health, Respiratory, Dermatology, Immunology, Bone, Cardiovascular and Diabetes.The person in this role will also lead a team of Regulatory Affairs liaisons focusing on regulatory activities in the EEA, Switzerland and Balkan countries.
Role responsibilities:

• Manage a team of Regulatory liaisons / Associate Regulatory liaisons and provide advice and support to teams cross-functionally/cross-divisionally on existing projects.
• Member of the core Regulatory Affairs Leadership team for the EMEA region – representing MSD for EU, Switzerland and the Balkans (Non-CES) counties.
• Define, develop, and ensure execution of innovative regulatory strategies for development and registration of the products in scope.
• Ensure high quality regulatory submissions, including original marketing authorization applications, post-approval variations, scientific advice briefing documents, and PIPs.
• Optimize the life-cycle management of all products in the therapeutic area and ensure regulatory compliance for the assigned products in the region.
• Contribute to the development of the portfolio in close collaboration with key stakeholders within MSD, in the subsidiaries and regional / global teams, as well as externally with the Regulatory Agencies for the projects assigned.
• Monitor, prioritize and supervise projects’ strategy, time lines, and milestones in compliance with applicable regulation, and ensure effective communication to / engagement from stakeholders.
• Take ownership of new projects in this context; projects may be complex, broad in scope, with multiple indications or formulations, and may involve external business partners.
MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.


 


Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.


 


 


 

Qualifications

• M.D., Pharm.D. or Ph.D. in life science, complemented with 6+ years of relevant experience is required.
• M.Sc. degree with substantial additional experience (6+ years) or a B.Sc. with an additional 8+ years experience in regulatory affairs or related discipline could suggest an equivalent ability to function in this position.
• Subject matter expert related to regulatory/risk communications and submissions, and advising on effective data and presentation approaches.

Competencies/Skills:

• Excellent interpersonal, written and verbal communication skills.
• People management skills at various levels.
• Demonstrate the ability to translate deep knowledge and experience in the global/regional/local regulatory landscape to advise on and drive MSD’s crossfunctional regulatory strategy.
• Able to effectively influence and negotiate with regulatory agencies related to MSD’s submissions, clinical risk management and pharmacovigilance strategies to achieve positive regulatory outcomes.
• Ability to build and maintain relationships with external scientific advisors on behalf of R&D.
• Viewed as a subject matter expert by internal and external stakeholders related to emerging trends/innovations and treatment best practices specific to a disease and therapeutic area.
• Applies extensive knowledge of translational medicine to make strategic ‘go/no-go’ decisions related to disease area studies.


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. 


Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.


 


 


 


 



Job: Regulatory Affairs Liaison
Other Locations:
Employee Status: Regular
Travel: Yes, 25 % of the Time
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


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