Sponsor Dedicated Regulatory Portfolio Snr. Regulatory Consultant; GRO RPSM) Spain, Portugal

Sponsor Dedicated Regulatory Portfolio Snr. Regulatory Consultant (GRO RPSM) open to Spain, Portugal and UK location

Updated: Yesterday
Location: Remote, LND, United Kingdom
Job :-OTHLOC-3526-2DR

Description

Sponsor Dedicated Regulatory Portfolio Snr. Regulatory Consultant (GRO RPSM) open to Spain, Portugal and UK location

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.

Discover what your 25,000 future colleagues already know:

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities

The Regulatory Project Manager role will work dedicated to a single Sponsor and will be responsible for providing regulatory project management support to the growing Sponsor Portfolio. This person will be a part of the Regulatory Project Management Function with the Sponsor and will support Global Regulatory Affairs.

Desired Experience
:

• Bachelor’s degree in life sciences, pharmacy, regulatory affairs, or related field; advanced degree preferred.
• Minimum of 8 years of experience in regulatory affairs or project management within the pharmaceutical/biotechnology industry
• Experience should include 7-10 years of participation in cross-functional project management activities.
• Expertise in global regulatory submissions and familiarity with FDA, EMA, and ICH guidelines.
• MUST have managed multiple Marketing Applications and/or LCM submissions at the same time and in multiple regions from submission to approval.
• MUST have pharmaceutical development and regulatory global submissions experience.
• MUST have prior experience with both small molecule and biologics.
• Strong organizational, communication, and problem-solving skills, with a focus on continuous improvement.
• Familiarity with the following regions for filing submission:
  Asia Pacific, Europe, United Kingdom, Switzerland, Russia, South America, Middle East, China, Japan, United States.
• Strong PM fundamentals (meeting facilitation & management, timeline management, critical path assessment, risk and issues management).

Other Qualifications
:

• PMP or similar certification preferred.
• RAC or similar certification preferred.
• Working knowledge with common project management systems required.
• Ability to multi-task and determine appropriate priorities…