Regulatory

Precision Health Economics Bethesda , MD 20813

Posted 3 months ago

We are excited to offer this newly crafted role leading Regulatory Affairs for Precision For Medicine, part of Precision Medicine Group, LLC. Precision Medicine Group, LLC is the leading global provider of precision medicine research services and creative commercialization solutions for life sciences companies. After completing the largest private investment raise of a life sciences services company in 2012, we have rapidly grown through a series of acquisitions and 20%+ annual organic growth to more than 1,500 people in over 25 offices across North America and Europe.

We are unusually positioned for growth as we expand the company's footprint and develop leadership in the most creative areas of life sciences as we help our clients develop and deliver lifesaving treatments to patients across the world. This is where you come in to make a difference.

The day to day view:

You will provide worldwide, leadership in and direction of the government regulatory requirements for product development utilizing knowledge and expertise to ensure compliance, including providing intelligence that may lead to development opportunities in this highly regulated environment. Directing all corporate Regulatory functions and facilitating business and proposal development for these areas.

  • Developing global regulatory strategy for clinical programs ensuring successful initiation, execution and submission for global registration.

  • Crafting and leading internal growth and resourcing strategy and mentoring regulatory staff.

  • Leading team preparation for regulatory agencies/Health Authority meetings.

  • Facilitating communications with regulatory agencies; preparing briefing and regulatory documents for regulatory agencies, such as Dossiers, NDAs, INDs/BLAs, and Annual reports. Providing oversight to filing and study teams regarding regulations/guidelines and company SOPs to ensure successful and high quality regulatory applications.

  • Coordinating critical reviews and providing strategic input on regulatory filing documents (e.g., eCTD Module 2 summaries, integrated summary documents, statistical analysis plans and clinical study reports).

  • Developing USPI/SmPC labeling activities with cross functional teams for planned regulatory submission

  • Leading business development activities

About You:

  • You have specialized knowledge of regulatory activities such as HAs, including NDA/ BLA/MAA, INDs/CTAs, IND/CTA amendments, safety reports, pre-meeting packages, and post-approval submissions consistent with global regulatory requirements

  • You understand clinical and pre-clinical study results to help in its interpretation for global regulatory positions and strategy

  • You are sought out by others to guide, train, and mentor others, fostering a flexible attitude with respect to work assignments, and new learning opportunities

  • You are committed to learning because the work of regulatory professionals is continuously shifting and expanding due to evolution in law, regulatory environments, technology, and global economics

  • You take a dedicated approach to sharpening your skills focusing on refining skills that complement this type of work, such as good communication, critical and analytical thinking, negotiation techniques, project management methods, and a collaborative mindset.

  • You champion a global perspective knowing that many policies still diverge significantly. You can synthesize this information on a global scale to produce efficient, culturally agile programs.

Qualifications:

Minimum Required: 4-year college degree, or equivalent experience ideally in a scientific or healthcare discipline

Other Required:

  • 20 + years relevant regulatory and/or clinical development pharmaceutical/biotechnology experience

  • Experience growing and running a global regulatory

  • Deep understanding of the drug development process

  • Significant experience in all aspects of meeting with Regulatory/Health Authorities supporting drug development

  • Proven ability applying knowledge of FDA, EMA, Global Heath Authority requirements and ICH guidelines both strategically and operationally, and providing direction to resolve complex regulatory issues

  • Proven experience developing global development strategies of groundbreaking and unique therapies

  • Expertise in preparing complex regulatory documents such as INDs, briefing packages (EOP2, EOP3, pre-NDA/BLA, Scientific Advice), NDAs/BLAs, and other major regulatory submission

  • Successful history leading business development activities

  • Ability to drive and travel domestic and internationally, including overnight stays (up to 40%)

Preferred: Advanced degree in life sciences or medical (MD, PhD, PharmD)Prior experience growing and managing a global regulatory CRO function, prior experience in device and companion diagnostics and hematology/oncology. RAC certification or Masters in regulatory sciences or related.


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Regulatory

Precision Health Economics