Associate Director, Regulatory Affairs and

2 days ago

Laval, Canada Altasciences Full time

Your New Company
At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them. No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team Whether you’re a recent college graduate or seeking your next career opportunity, it’s time to discover your future at Altasciences.

We are better together and together We Are Altasciences.

About The Role

The Associate Director, Regulatory Affairs and Submissions, is responsible for providing regulatory guidance to Sponsors related to drug development and submission requirements, leading the initiation (requests), preparation (meeting packages), and conduct of a variety of Agency interactions (Type A - C, INTERACT meetings), leading regulatory submission preparation (including assessing for gaps in requirements) and filing activities, may act as a project resource for junior staff/peers to ensure workload is managed, strategies are aligned, and submissions are of the highest quality.

What You’ll Do Here- Work closely with business development team and sponsors to understand sponsor’s needs and interests, and to provide regulatory guidance related to drug development and submission preparation- Interact with sponsors as a regulatory consultant to build trust and encourage engagement- Evaluate, develop, plan and prepare regulatory submissions (INDs primarily) for new drugs under development with the collaboration of multiple cross-functional teams- Provide critical review of key Health Authority submissions such as pre-IND, IND, meeting requests, briefing documents and response documents- Perform gap analysis for drug development programs and to inform regulatory strategies- Interpret laws and regulations (FDA, Health Canada, ICH, EMA, and MHRA)- Lead, manage and prepare clinical trial submissions- Lead, manage, prepare, and submit meeting requests and meeting information packages to health agencies- Communicate, consult and negotiate with health authorities- Respond in a timely manner to health authority requests- Resolve issues in a timely manner- Participate to sponsor’s audits and regulatory inspections- Provide regulatory input into client-provided proposals- Maintain a positive, result orientated work environment, build partnerships with cross-functional teams/departments, maintain a positive team-based culture- Support business development for proposals and costing; support bid defense meetings- Participate in the development of standard operating procedures (SOPs)- Coordinate with internal teams to deliver high-quality documents in accordance with agreed upon timelines- Conduct all work in compliance with SOPs, Good Clinical Practice (GCP), and all regulatory guidelines- Participate in departmental or interdepartmental quality improvement initiatives- Train and mentor other team members- Maintain and participate in the objectives of the department

What You need to Succeed- MSc/MS, PhD in a relevant field; 5+ years of predominantly US regulatory experience in an industry setting- Strong knowledge of drug development and regulatory policy including ICH, FDA, and Health Canada guidelines related to early phase drug development- Demonstrated experience with leading IND submissions in US, experience with other regulatory agencies an asset- Ability to assess nonclinical data for gaps in an IND-enabling package- Leadership skills- Excellent verbal and written communication skills-
- Professional attitude and strong interpersonal skills- Ability to work well with a multi-disciplinary team of professionals- Client-focused approach to work- Flexible attitude with respect to work assignments and new learning- Ability to prioritize workload- Thorough understanding of clinical research, drug development process and applicable regulatory guidance- Strong computer skills (Microsoft Word, Excel, and Power Point) and ability to understand and adapt to various information technology (IT) systems- Experience with Health Canada is an asset. Willingness to learn is required.

What We Offer

Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.

Altasciences’ Benefits Package Includes:
- Health/Dental/Vision Insurance Plans- 401(k)/RRSP with Employer Match- Paid Vacation and Holidays- Paid Sick and Bereavement Leave- Employee Assistance & Telehealth Programs- Telework when applicable

Altasciences’ Incentive Programs Include:
- Training & Development Programs- Employee Referral Bonus Program- Annual Performance Reviews

MOVING IN UNIS

  • Regulatory Affairs Officer

    3 days ago

    Laval, Canada Basse Freres Alimentation Orientale (2013) INC. Full time

    **Management Consultant Specific Skills**: - Propose improvements to methods, systems and procedures - Conduct research to determine efficiency and effectiveness of managerial policies and programs **Business Equipment and Computer Applications**: - MS Excel - MS PowerPoint - MS Word - MS Outlook **Additional Skills**: - Supervise staff **Area of...

  • Research Associate

    4 hours ago

    Laval, Canada Charles River Laboratories Full time

    For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will...

  • Scientist - Bioanalytical

    5 days ago

    Laval, Canada Charles River Laboratories Full time

    For 70 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will...

  • Client Account Associate

    4 days ago

    Laval, Canada Jones DesLauriers Insurance Management Inc. Full time

    **WHAT WE OFFER** - Great learning and growth opportunities - Hybrid remote work flexibility - A competitive compensation package - Full Benefits Package - RRSP Matching Program - Professional Development Courses & Designations - 100% tuition re-imbursement for business relevant courses and training - Half volunteer day to make a difference and give back to...

  • Associate Scientist Bacteriology Lab

    6 hours ago

    Laval, Canada IQVIA Full time

    **Associate Scientist Bacteriology Lab Operations*** **Job Overview**: Responsible for performing routine analysis and laboratory testing procedures to obtain data for use in drug development and clinical trials research. **Essential Functions**: - Responsible for performing and documenting analytical procedures in accordance with SOPs and regulatory...

  • Research Associate Pharmacy

    4 days ago

    Laval, Canada Charles River Laboratories Full time

    For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will...

  • Quality Assurance

    7 days ago

    Laval, Canada Bausch Health Companies Full time

    Quality Assurance & Compliance Specialist (Regulatory Compliance-CMC) (8296) **Career Opportunities: Quality Assurance & Compliance Specialist (Regulatory Compliance-CMC) (8296)** Requisition ID **8296** - Posted - **Canada** - **Quality** - **CA - Laval** - City (1) Bausch Health Canada is the international head office of Bausch Health Companies, one of...

  • Business Development Associate

    6 days ago

    Laval, Canada Thryv Therapeutics Inc. Full time

    **Associate - Business Development** - Thryv Therapeutics Inc., previously called LQT Therapeutics Inc., is a privately owned company based in Montreal, Quebec, Canada. They have been pioneering a precision medicine approach to treat Long _ - QT Syndrome via SGK-1 inhibition since 2019 and have since evolved their portfolio to include the treatment of...

  • Personal Banking Associate

    6 days ago

    Laval, Canada BMO Financial Group Full time

    23 boul Samson Laval Quebec,H7X 3S5 Delivers exceptional service to BMO customers and prospects. Identifies customer needs and provides advice and guidance regarding financial solutions that are in the best interests of customers. Works collaboratively within the branch and with BMO partners to deliver the desired customer experience and achieve overall...

  • Avocat Corporatif

    8 hours ago

    Laval, Canada GA International Full time

    Leader de l'industrie depuis vingt ans, GA International offre des solutions complètes d'étiquetage et d'identification des laboratoires aux secteurs biomédical et biopharmaceutique, ainsi qu'aux secteurs universitaire, gouvernemental et commercial. Notre siège social est situé à Laval, au Québec, et nous sommes présents aux États-Unis, aux Pays-Bas...

  • Product Marketing Advisor(Wealthtech saas)

    9 hours ago

    Laval, Canada Croesus Full time

    **Position**: **Strategy** - Define markets, target segments, and personas. - Define the positioning, narratives, and key messages of our solutions. - Define differentiators for each solution. - Play a central role in the strategic planning process. - Contribute significant elements to the company's strategic thinking, based on facts and trends. - Define...

  • QHSE Manager

    4 days ago

    Laval, Canada Fed Manutech Canada Full time

    Introduction : Hello, I'm Maxime Somaglino, consultant at FED Manutech, a specialist in permanent recruitment for the manufacturing, engineering and engineering professions.We support our candidates throughout their careers by offering them stimulating opportunities tailored to their profiles and ambitions.Your functionOur client, a Laval-based company...

  • QHSE Manager

    2 days ago

    Laval, Canada Fed Manutech Full time

    Hello, I'm Maxime Somaglino, consultant at FED Manutech, a specialist in permanent recruitment for the manufacturing, engineering and engineering professions. We support our candidates throughout their careers by offering them stimulating opportunities tailored to their profiles and ambitions. Your function Our client, a Laval-based company specializing in...

  • QHSE Manager

    2 days ago

    Laval, Canada Fed Manutech Full time

    Hello, I'm Maxime Somaglino, consultant at FED Manutech, a specialist in permanent recruitment for the manufacturing, engineering and engineering professions. We support our candidates throughout their careers by offering them stimulating opportunities tailored to their profiles and ambitions. Your function Our client, a Laval-based company specializing in...

  • Fed Manutech | QHSE Manager

    6 days ago

    laval, Canada Fed Manutech Full time

    Hello, I'm Maxime Somaglino, consultant at FED Manutech, a specialist in permanent recruitment for the manufacturing, engineering and engineering professions. We support our candidates throughout their careers by offering them stimulating opportunities tailored to their profiles and ambitions. Your function Our client, a Laval-based company specializing in...

  • QHSE Manager

    2 days ago

    Laval, Canada Fed Manutech Full time

    Hello, I'm Maxime Somaglino, consultant at FED Manutech, a specialist in permanent recruitment for the manufacturing, engineering and engineering professions. We support our candidates throughout their careers by offering them stimulating opportunities tailored to their profiles and ambitions. Your function Our client, a Laval-based company specializing in...

  • Immunology Scientist I

    9 hours ago

    Laval, Canada Charles River Laboratories Full time

    **Req ID #**:223556**Location**:Laval, Quebec, CA, H7V 4B3- For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life...

  • Associé(E) Des Opérations Administratives

    6 days ago

    Laval, Canada Groupe Belmont Inc. Full time

    Groupe Belmont est une entreprise dynamique et en pleine croissance, spécialisée dans les services d’aménagement paysager, y compris les systèmes d’irrigation, l’éclairage de fêtes et l’éclairage paysager. Nous sommes fiers de fournir un service exceptionnel et de maintenir des relations solides avec nos clients. Nous recherchons une personne...

  • Specimen Management Associate

    6 hours ago

    Laval, Canada IQVIA Full time

    Dotés d’une expertise inégalée en immunologie et présents en Amérique du Nord (côte Est et Ouest) et en Europe, Nexelis est l’un des principaux prestataires de services dans le domaine du développement et l’analyse de tests biologiques spécialisés en infectiologie, métabolisme, et cancérologie. Notre équipe polyvalente de scientifiques,...

  • Capital Equipment Specialist

    7 days ago

    Laval, Canada Bausch Health Companies Full time

    Solta, a division of Bausch Health, is committed to improving patients quality of life by delivering sophisticated technology in simple, elegant designs, providing true aesthetic and therapeutic benefits. For more than a decade, we've been developing innovative treatment technologies to provide proven and effective aesthetic care options to consumers and...