Senior Manager / Associate Director, Regulatory Affairs

Lowell, MA     ·      Full time

Job Summary:

Alcyone Therapeutics is a therapeutic technology company developing precision delivery platforms for the treatment of neurological and oncological disorders. Reporting to the Director of Regulatory Affairs, the Senior Manager/Associate Director, Regulatory Affairs will be responsible for the strategy development and management of all regulatory activities.

This position is responsible for the day-to-day execution of Regulatory requirements of the company, including regulatory strategies, regulatory submissions, CRO management and support of verification and validation testing to support regulatory submissions; as well as compliance audit support and regulatory body inspection/audits.

This role will also support clinical trial submissions and reporting as applicable, and support quality functions involving complaint handling and reporting, CAPAs, and NCRs.

Open, effective, and proactive communication of regulatory activities is critical for success in this role. Must have an excellent understanding of the drug/device development process in order to effectively manage internal and external cross-functional teams. Must have strong work ethics and be able to work independently and productively. Must be willing to travel for agency meetings and/or device development activities..

Essential Responsibilities/Functions:

To perform this job successfully, an individual must be able to perform each essential function satisfactorily:

• Work with Executive Management and the Director of Regulatory Affairs to identify, analyze and communicate new or changing regulatory requirements to the company and its impact on the business.
• Actively manage CRO global regulatory activities to ensure on time regulatory submissions.
• Take direction, lead, serve as the primary contact and execute regulatory activities and responsibilities for all domestic and international regulatory activities (IDE’S, PMA’s, 510(k)’s, CE Design and Technical Dossiers, etc.)
• Represent regulatory affairs at applicable project team meetings and work effectively with a cross-functional team to develop a strategic regulatory plan for each program.
• Perform eMDR submissions to FDA for all MDR reportable events/circumstances.
• Work with members of the regulatory team to ensure regulatory submissions are completed on time and according to the associated requirements.
• Work with Product Development, Marketing, Clinical Operations, and other departments as needed to ensure that all product labeling, instructional and promotional materials are in compliance with regulatory requirements.
• Actively comply with Alcyone’s Quality System.
• Participate in regulatory audits as required to maintain ISO/QSR compliance.
• Perform all administrative activities associated with the department. This will include supporting the department’s goals and objectives.

Education/Qualifications:

• University/college degree required, Master’s Degree preferred in biomedical engineering or the life sciences.
• In lieu of this required educational background the following relevant work history may be considered:
  • Minimum of five to 7 (5-7) years supervisory experience in a regulatory affairs in a pharmaceutical or medical device company or CRO, preferably with experience in Class III IDE/PMA submissions and combination products.

Further Qualifications Include:

•  Regulatory Affairs Certification (RAC) preferred

Skills and Abilities:

The ideal candidate will possess the following skills and abilities:

• Comprehensive knowledge of current GCPs, GMPs and GLPs and ICH regulations.
• Class III IDE/PMA experience. Master Access Files (MAF), eMDR reporting, 510(k), EU Tech File and De Novo Filings a plus.
• Experience with combination device products.
• Ability to manage, mentor and develop staff in order to maximize their capabilities and contributions to the company.
• Experience and understanding working with US FDA, European, and Global regulatory authorities (ex: Japan PMDA). Understanding of said regulatory requirements.
• Must be capable of succeeding in a small company environment. The required skills will include strong leadership, and effective communication style, excellent organizational skills and a good blend of discipline and creativity.
• Evidence of leadership and a management style characterized by vision, teamwork, preparation, communication and negotiation.
• Successful management of relationships at all levels of the organization
• High energy and results-oriented individual who is mature and successful in a business environment and is skilled in motivating and inspiring people.
• Strong written, verbal and presentation skills, including accomplished public speaking skills with the ability to present, persuade and convince regulators, investors and key opinions leaders with respect to the company’s products and regulatory strategies.
• Skillful and effective delegation of tasks to others, while maintaining responsibility for performance and outcomes.
• Excellent verbal and written communication skills.
• Team-oriented individual with strong interpersonal skills, management and leadership skills
• Strong leadership, excellent organizational skills, and a good blend of discipline and creativity.
• Solid analytical skills and the ability to identify risk and problem solve quickly.
• Commitment to company with ability to function within a start-up environment.
• Skilled in Microsoft Office (Word, Excel, PowerPoint, Project, and Outlook).
• Makes good decisions in a timely manner, based upon a mixture of analysis, wisdom, experience, judgment and direction.

Please click here to apply.