Pharming Healthcare Inc
Pharming Healthcare Inc Warren MI United States
2 weeks ago
Pharming is a fully integrated biopharmaceutical company, developing innovative products for the treatment of rare diseases and unmet medical needs. Headquartered in the Netherlands the company also has locations in France and the US and is listed both in Amsterdam and the US on the NASDAQ stock exchange...
Our growing team of 300 is ready for further scientific, technological, and new product development, as well as global commercial rollouts.
We are an open organization with ambitious and passionate people who are committed to the company, the colleagues, and the patients we serve. A good base of self-awareness, leadership, respect and teamwork, is a platform to support high performance and a pleasant workspace.
Together to get ther(e)
"We hire for attitude and train for skills" is our simple mantra, but one that has a profound impact on how we select new employees.
Purpose of the role
The Global Regulatory Affairs Project Management role is responsible for supporting the development of global regulatory strategies to ensure the timely delivery of regulatory submissions and Heath Authority interactions, including all aspects of planning and project management. The GRA-PM works cross-functionally with global team members, coordinating the regulatory work stream elements for submission document preparation activities, while proactively identifying any regulatory risks. The GRA-PM plays a key role in supporting regulatory strategies for Pharming products whether in research and development or in post-marketing
Areas of Responsibility
• Lead the coordination of regulatory submissions by preparing and communicating comprehensive timelines which contribute to meeting the end goal.
• Project manages regulatory submission activity by developing and maintaining tools to assist in timeline tracking and submission management.
• Tracks progress against developed timelines and holds cross-functional Team meetings to assess progress and identify gaps or risks, preparing reports and communicating timelines to management.
• Has an in-depth understanding of complex scientific information and development data to expertly develop and maintain regulatory timelines.
• Lead interactions, interfaces, and collaborations with a diverse group of content authors to discuss planned submission preparation and ensure that documents comply with regulatory guidance/template specifications.
• Liaise with clinical operations and CMC to capture interdependencies and contribute to developing timelines.
• Assist in the creation of content plans alongside the Global Regulatory Affairs Strategists, track content, and prepare reports for cross-functional communication purposes.
• Coordinates with the Regulatory Operations team to ensure timely and accurate submissions to Health Authorities.
• Work collaboratively with the Corporate Project Management Team to ensure the timely delivery of updates on key regulatory milestones and activities.
• Partners with Legal and Finance Teams to manage Global Regulatory Affairs contracts and other financial documentation.
What you'll need to succeed
• Bachelor's Degree
• 8+ Years' experience in Project Management
• 4+ Years'experience in a pharmaceutical industry
• Ability to work effectively collaborating across a global organization
• 6+ Years of Experience in a rare disease space
• Knowledge of eCTD submissions and standards.
• Excellent organization, project management and multi-tasking/prioritization skills
• Strong verbal and written communication, and interpersonal skills
• Proven track record for consistently meeting or exceeding goals and objectives
What you'll get in return
We offer you a permanent position with an excellent remuneration scheme, including:
• A highly Competitive Salary
• Annual Bonus
• 20 Days PTO
• Excellent Health Care Benefits
• 401k Package
You will also join our Learning & Development program, which can offer a tailor made development plan, based on your personal and professional needs. Learning opportunuities are everywhere, in all forms imaginable and we want to create learning memories for all "Pharmers."
Also important - We truly value a healthy life-work balance with a lot of flexibility.
Apply for the job
Does this sound like you and you want to join our team? Then we'd love to hear about you
Warren MI USA
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