Associate Project Manager Regulatory Affairs

2 days ago

Brossard, Canada Mantra Pharma Full time

_**Why join us?**_
- Hybrid position with a flexible schedule;
- Regular, full-time position;
- Group insurance, including telemedicine and a health spending account;
- Vacation and paid time off during the holiday season;
- Group RSP with employer contribution;
- 4 sick days per year;
- Free indoor parking;
- Office near the DIX30 REM station;
- And much more

Reporting to the Regulatory Affairs Manager, the Associate Project Manager Regulatory Affairs will participate in the preparation and submission of various regulatory documents to ensure timely approval and regulatory maintenance/compliance of the product portfolio (DIN and NHP) in accordance with applicable laws, regulatory guidelines and policies.
- **Main tasks and responsibilities**_
- Registration of generic pharmaceutical products and Natural Health Products according to the Health Canada Standards and predefined timelines, involving:

- Critical assessment of scientific data and gap analysis for Module 2 and Module 3 to meet Canadian requirements;
- Responses to clarification request within deadlines set by Health Canada;
- Maintain the regulatory compliance for approved/marketed products on the Canadian market, in compliance with the Food and Drugs Act, its Regulations, and all relevant Canadian guidelines;
- Ensure the management of aspects related to the development of product label content;
- Participate in the development and implementation of regulatory strategies;
- Negotiate and create efficient bonds with Health Canada (pre-submission meetings, Clarifax, etc.);
- Ensure follow-ups and updates of various databases and post-approval activities related to regulatory documents;
- Participation in due diligence activities;
- Effectively conduct follow-ups with corporate partners;
- Participate in the regulatory reviews of other departments;
- Compile and develop regulatory files (submissions, responses ), in eCTD format:

- Uploading files in eCTD software;
- Publishing in eCTD format;
- Submitting through CESG;
- Perform other related tasks required by the manager.
- **Qualifications**_
- Master's degree in life sciences (chemistry, biology, biotechnology) or other relevant fields;
- Minimum of 5 years of experience in a regulatory position within the generic pharmaceutical industry;
- Excellent oral and written communication skills in French and English (to interact with partners and employees outside Quebec and to send submissions to Health Canada);
- Proficiency in Microsoft Office, Adobe and ERP systems;
- Strong analytical skills in CMC and clinical aspects;
- Excellent knowledge of Canadian regulations and ability to interpret policies and guidelines;
- Strong technical writing skills, ability to evaluate and critique regulatory documents.
- **Applicant’s profile**_
- Detail-oriented with strong analytical and organizational skills;
- Ability to work effectively in a team and manage multiple projects simultaneously;
- Ability to perform under pressure and meet tight deadlines.

**Job Types**: Full-time, Permanent

**Benefits**:

- Casual dress
- Company events
- Disability insurance
- Employee assistance program
- Extended health care
- Flexible schedule
- Life insurance
- On-site parking
- Paid time off
- RRSP match
- Store discount
- Work from home

Schedule:

- 8 hour shift
- Day shift
- Monday to Friday
- No weekends

Work Location: Hybrid remote in Brossard, QC

  • Directeur, Affaires juridiques

    1 day ago

    Brossard, Quebec, Canada ZSA Canada Full time

    Directeur, Affaires juridiques8-11 ans | BrossardDes transactions complexes et sophistiquées à souhait, mais en entreprise?Lisez ce qui suitNotre client,Novacap, est un chef de file nord-américain dans le domaine du placement privé, avec plus de 15 milliards $ canadiens d'actifs sous gestion. Novacap a investi dans plus de 100 sociétés et réalisé...

  • Technical Project Manager

    5 days ago

    Brossard, Canada Acuity Brands Full time

    Distech Controls’ success and reputation are fueled by our world-class team of employees. We look for qualified individuals who are striving to succeed and that wish to actively contribute to our continued growth. Distech Controls values its team members and offers them a modern, motivating work environment, and competitive salaries and benefits. **Who is...

  • Directeur, Affaires juridiques

    2 weeks ago

    Brossard, Canada ZSA Canada Full time

    Directeur, Affaires juridiques 8-11 ans | Brossard Des transactions complexes et sophistiquées à souhait, mais en entreprise? Lisez ce qui suit! Notre client, Novacap , est un chef de file nord-américain dans le domaine du placement privé, avec plus de 15 milliards $ canadiens d’actifs sous gestion. Novacap a investi dans plus de 100 sociétés et...

  • Directeur, Affaires juridiques

    2 weeks ago

    Brossard, Canada ZSA Canada Full time

    Directeur, Affaires juridiques 8-11 ans | Brossard - Des transactions complexes et sophistiquées à souhait, mais en entreprise? Lisez ce qui suit! Notre client, Novacap, est un chef de file nord-américain dans le domaine du placement privé, avec plus de 15 milliards $ canadiens d’actifs sous gestion. Novacap a investi dans plus de 100 sociétés et...

  • Directeur, Affaires juridiques

    2 weeks ago

    Brossard, Canada ZSA Canada Full time

    Directeur, Affaires juridiques 8-11 ans | Brossard Des transactions complexes et sophistiquées à souhait, mais en entreprise? Lisez ce qui suit! Notre client, Novacap , est un chef de file nord-américain dans le domaine du placement privé, avec plus de 15 milliards $ canadiens d’actifs sous gestion. Novacap a investi dans plus de 100 sociétés et...

  • Directeur, Affaires juridiques

    3 days ago

    Brossard, Canada ZSA Canada Full time

    Directeur, Affaires juridiques 8-11 ans Brossard Des transactions complexes et sophistiquées à souhait, mais en entreprise? Lisez ce qui suit! Notre client, Novacap , est un chef de file nord-américain dans le domaine du placement privé, avec plus de 15 milliards $ canadiens d'actifs sous gestion. Novacap a investi dans plus de 100 sociétés et...

  • General Manager-Multi-Project Operations

    3 weeks ago

    Brossard, Canada H&M Global Consultation Full time

    General Manager – Multi‑Project Operations We are launching a new, multi‑project initiative within a large commercial building, bringing together several complementary business units under one operational umbrella. Our goal is to build a dynamic, efficient, and scalable ecosystem that delivers exceptional customer experience and strong financial...

  • General Manager-Multi-Project Operations

    3 weeks ago

    Brossard, Canada H&M Global Consultation Full time

    General Manager – Multi‑Project Operations We are launching a new, multi‑project initiative within a large commercial building, bringing together several complementary business units under one operational umbrella. Our goal is to build a dynamic, efficient, and scalable ecosystem that delivers exceptional customer experience and strong financial...

  • General Manager-Multi-Project Operations

    4 weeks ago

    Brossard, Canada H&M Global Consultation Full time

    About our Company We are launching a new, multi-project initiative within a large commercial building, bringing together several complementary business units under one operational umbrella. Our goal is to build a dynamic, efficient, and scalable ecosystem that delivers exceptional customer experience and strong financial performance. Position Overview We...

  • General Manager-Multi-Project Operations

    4 weeks ago

    Brossard, Canada H&M Global Consultation Full time

    About our Company We are launching a new, multi-project initiative within a large commercial building, bringing together several complementary business units under one operational umbrella. Our goal is to build a dynamic, efficient, and scalable ecosystem that delivers exceptional customer experience and strong financial performance. Position Overview We are...