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Director; Regulatory Affairs
Gelesis is developing a novel hydrogel platform technology to treat overweight and obesity and chronic diseases related to the GI pathway. Gelesis’ proprietary approach is designed to act mechanically in the GI pathway to potentially alter the course of certain chronic diseases. In April 2019, Gelesis received FDA clearance for its lead product candidate, Plenity™, as an aid for weight management in overweight and obese adults with a Body Mass Index (BMI) of 25-40 kg/m2, when used in conjunction with diet and exercise. Plenity is currently available in limited supply in the U.S. Additionally, Gelesis is developing its second investigational candidate, Gelesis200, a hydrogel optimized for weight loss and glycemic control in patients with type 2 diabetes and prediabetes. Novel hydrogel mechano-therapeutics based on the Gelesis platform technology are also being advanced in other GI inflammatory conditions, such as non-alcoholic steatohepatitis (NASH) and Chronic Idiopathic Constipation (CIC).
Gelesis was also named one of Fast Company’s Most Innovative Companies for 2020.
The Gelesis executive and advisory team includes some of the world’s leading experts in obesity, materials science, chronic disease research, and commercialization. Gelesis was co-founded by PureTech Health (LSE: PRTC). For more information, visit gelesis.com or connect with us on Twitter @GelesisInc.
Director of Regulatory Affairs
Reporting directly to the Sr. Director/ Head of Regulatory & Quality, the Director of Regulatory Affairs will develop global regulatory strategies for the Gelesis products, execute regulatory plans to support the Gelesis business goals, and promote regulatory compliance throughout the organization and throughout the lifecycle of our products. Working in cross-functional teams this position will ensure that labeling and promotional material complies with applicable laws and regulations. Key responsibilities of this function include but are not limited to:
- Develop domestic and global regulatory strategies and plans which support company goals
- Author regulatory filings in cooperation with Operations, Development, and Clinical teams to obtain timely market authorizations.
- Directly communicate and collaborate with regulatory authorities (FDA, Health Canada, Notified Body and others)
- Manage programs for device and establishment registrations and UDI/GUDID compliance
- Perform regulatory impact assessments of process and product changes to determine reportability. Prepare documentation for no-filing decisions.
- Define regulatory policies and processes in written procedures. Promote and monitor compliance to these processes.
- Represent Regulatory Affairs in cross functional product development teams, identify regulatory requirements, and participate in design reviews.
- Participate and support compliance related activities, including internal Quality System Audits and inspections by regulatory authorities.
- Manage initiatives to maintain or obtain compliance to new or emerging regulations, such as EU MDR, MDSAP.
- Maintain corporate regulatory files.
- Represent Regulatory Affairs in cross-functional teams for the review and approval of promotional material and labeling.
- Represent RA on cross functional teams for review and approval of training and non-promotional customer facing material.
- Promote awareness of evolving regulations and guidance documents relating to promotional materials and labeling, including advisory and enforcement letters.
- Manage/prepare pre-clearance and regulatory submissions relating to labeling and promotional material to regulatory authorities.
Education and Training
- A Bachelor’s Degree in a science field required; PhD or PharmD preferred
- A minimum of 10 years of experience in Medical Device Regulatory Affairs environment, including proven experience with:
- The review of advertising/promotional materials for medical devices.
- regulatory submissions (510k, de novo, class III design dossiers)
- European and international regulations (MDD, MDR, CMDR, MDSAP)
- Proven experience presenting to the FDA and foreign regulatory bodies
- Detailed knowledge of FDA regulations and guidance documents pertaining to labeling and advertising/promotional materials.
- Working knowledge of international standards for risk management, design controls, biocompatibility, usability engineering etc.
- Understanding of hydrogel technologies would be very advantageous (but not required)
Skills and Abilities
- Strong critical thinking and problem-solving skills.
- Data driven, ethical decision-making skills.
- Excellent communication and presentation skills
- Excellent time management and organizational skills
- Flexible and adaptable to changing project priorities, work assignments and deadlines.
- Detailed oriented
- Experience in working in a fast paced, high-volume & cross functional environment handling multiple tasks
- Reliable, conscientious and discreet
- Proven ability to prioritize and multitask
- Self-motivated, shows initiative, is proactive and able to work independently as well as in a team.
- Strong computer skills including knowledge of Excel, Word, and PowerPoint
- Flexible to take on other duties as assigned
Gelesis is an equal opportunity employer. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, veteran status, a person’s size or weight, or any other status protected under federal, state, or local law.
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