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Senior/Manager, Regulatory Affairs - Europe - Home or Office Based

Remote:

Full Remote

Contract:

Full time

Experience:

Senior (5-10 years)

Work from:

United Kingdom

Offer summary

Qualifications:

Four-year degree in relevant science or related field, Two-year college or equivalent education with eight years experience, Minimum five years in pharmaceutical/CRO industry, Proficient in spoken and written English.

Key responsabilities:

Review budgets, negotiate contracts, and prepare regulatory proposals
Manage ethics committee submissions across multiple regions
Provide expert regulatory advice and status updates to stakeholders
Prepare technical documentation in compliance with regulations
Train, coach, and possibly manage junior staff

Lifelancer Information Technology & Services Startup https://lifelancer.com/

11 - 50 Employees

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Job description

We believe everyone playsan important rolein making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day.Join us!

What you will do

Review study budgets and costing pertaining to contract negotiation, participate in business development activities, prepare regulatory sections of proposals and feasibility reports and attend bid defense meetings to meet business needs
Coordinate manage regulatory ethics committee submissions and maintain approvals throughout EMEA, Asia Pacific and Latin America regions and ensure accurate compilation, management and tracking of submissions
Provide expert regulatory advice and contribute to regulatory project work. Effectively communicate status of submissions with the Sponsor, Project Manager, CRAs, Medical Scientific Affairs staff. Contribute towards the preparation of technical documentation such as IMPDs and IBs, review and make recommendations on all relevant documentation to ensure compliance with ICH GCP country specific requirements
Provide training, coaching and mentoring to junior members of staff, may be required to line manage junior members of staff

What you will bring to the role

Clearly, proven leadership and organizational management skills are essential attributes
Strong planning, strategizing, managing, monitoring, scheduling, and critiquing skills
Excellent written and verbal communication skills to clearly and concisely present information
Relationship-building competency combined with demonstrated comfort supporting Business Development at face-to-face meeting
Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
Excellent ability to handle multiple tasks in a fast-paced and constantly changing environment

Your experience

A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science, OR
Two-year college curriculum or equivalent education / training (nursing degree or equivalent life science degree) and eight years experience within clinical research (e.g. CRA, Reg Affairs.)
Minimum 5 years within pharmaceutical/CRO industry, with demonstrated senior level regulatory or clinical start-up experience
Proficient in cross-cultural communication and proficient in both spoken and written English

Lifelancer ( https://lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech, data science and IT domains.

Please use the below Lifelancer link for job application and quicker response.

https://lifelancer.com/jobs/view/876f34d1222ff285bbfad4f21effb034