Director, Regulatory Affairs (Remote - United States)

Company Description

Sirtex Medical is a global healthcare business with offices in Boston, Sydney, Germany, and Singapore, working to improve outcomes in people with cancer. Our current lead product is a targeted radiation therapy for liver cancer called SIR-Spheres® Y-90 resin microspheres. More than 100,000 doses have been supplied to treat patients with liver cancer at more than 1,300 medical centers in over 50 countries. We’re a fast-growing dynamic organization and we seek an experienced Manufacturing Technician to help us with our growth.  

At Sirtex, we’re transforming our industry through our leadership with interventional oncology and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. We offer stimulating careers and development, encourage innovation, and strive for excellence in everything we do. We will always foster a diverse and inclusive workplace, in which our global teams are united by an unwavering commitment to improve the quality and longevity of patients’ lives by providing innovative interventional oncology solutions. 

Our facility in Wilmington, MA is responsible for the manufacturing of time sensitive high-energy beta radiation to support the treatment of inoperable liver tumors.  We are looking for a high energy, self-motivated, team player, with a passion for making a difference to join our diverse team.

Job Description

The Director of Regulatory Affairs will be responsible for overseeing the development and implementation of regulatory strategies for product development and commercialization in emerging disease areas. This person will play a role in shaping cohesive regulatory strategies across all programs and ensure the effective integration of broad regulatory idea/strategies supporting Sirtex's overall strategic intent and company goals. 

Key Responsibilities Include:

• Lead and carry out the regulatory strategy for complex projects in development
  (first-in-human through commercialization and post marketing)
• Responsible for assisting in the preparation and compilation of global product
  submissions. This may include but not limited to: INDs, NDAs, IDEs, PMAs,
  CTAs, MAAs, expedited regulatory pathways and/or CE technical files
• Assess project plans and timelines and assign and manage resources effectively to
  ensure all projects are appropriately prioritized and key company goals are met on
  time
• Represent regulatory on project teams to ensure unified regulatory input across the
  development program
• Address complex issues, providing innovative regulatory solutions and guidance
  to cross-functional teams
• Ensure the regulatory strategy for a project is consistent with the business
  objectives and has been negotiated with relevant health authorities as appropriate
• Review and approve regulatory submission documents and regulatory agency
  communications
• Ensure compliance of regulatory strategies and submissions with current
  regulations and guidance
• Contribute to the continuous improvement of existing department procedures and
  processes, providing recommendations for areas of growth
• Review design and product information changes and develop proactive strategy
  accordingly
• Advise senior leadership team of regulatory affairs strategies and tactics, procedures and practices
• Provide overall leadership to the regulatory affairs team in the skill development, coaching and performance feedback for members
• Lead and participate in regulatory inspections as required
• Undergo all formal Training Events as may be Directed from time-to-time
• Observe and Comply with all Sirtex Corporate Policies
• Work within, and ensure adherence to Quality System procedures, work instructions and other Quality System requirements.

Qualifications

• Bachelor's Degree - Minimum 8 years experience in the medical device/pharmaceutical industry, with 4+ years of leadership experience
• Demonstrated experience in preparing and gaining approval for all types of US and international based submissions
• Proven track record of increasing responsibilities within regulatory affairs
• Strong understanding of global pre & post market regulatory requirements
• Be a self starter and have the ability to work independently to drive projects when needed
• Strong organization and time management skills
• Excellent negotiation skills
• Excellent oral and written communication skills with attention to detail

Additional Information

All your information will be kept confidential according to EEO guidelines.

Do you want to be part of something bigger? A team whose impact stretches across the globe making a real difference to the quality of people’s lives.  Sirtex recognizes