Director, Regulatory Affairs
Location: Woburn, MA
Posted Date: 10/21/2022
Who We Are
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.
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
- Represent regulatory on project teams to ensure unified regulatory input across the
- 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
- 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
- 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.
Who You'll Be
- 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
What to Expect from Us
If you have the right skills and experience and want to work for a company making a real difference to the quality of people’s lives, Sirtex will offer the right candidate:
- Diverse and flexible employment and working arrangements to achieve the optimum balance between work and personal responsibilities and objectives.
- A working culture of respect, diversity, and performance to help facilitate an inclusive culture.
- Attractive compensation and benefit packages which are practical, robust, fair, and equitable.
- A place to grow through career development and training opportunities.
- Challenging work to continue to develop new and better ways to improve clinical outcomes for oncology treatment around the world.
Conditions of Employment
- Sirtex Medical has implemented a mandatory vaccination policy effective November 1, 2021, requiring the COVID 19 vaccination for all employees. In accordance with Sirtex’s duty to provide and maintain a workplace that is free of known hazards, we are adopting this policy to safeguard the health of our employees and their families, and the community at large from infectious diseases that may be reduced by vaccinations.
- Individuals seeking an exemption from this requirement for medical or religious reasons should complete a request for accommodation form and submit the form to the human resources department.
Sirtex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law. Sirtex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Diversity drives innovation; inclusion fosters belonging, growth and success. Sirtex believes that it takes multiple perspectives and voices to create a culture and workplace which fosters engagement, teamwork, and employee satisfaction to perform our best and deliver on commitments. We are dedicated to fostering an environment where all employees feel valued, included, and can share their ideas so that we can exceed even our own expectations.
Be part of an amazing team that is helping to save lives, every day.