Specialist, Regulatory Affairs

4 months ago

Boucherville, Canada Sandoz Full time

As a **Specialist, Regulatory Affairs **and part of a high-performing and inclusive team of regulatory experts, you will work on exciting projects that deliver affordable, quality medicines to patients every day.

**Your Key Responsibilities**:
Your responsibilities include, but not limited to:

- Develop scientifically sound regulatory strategies for products in development, in line with regulatory guidance for ANDS/NDS/SANDS/SNDS submissions related to generic and biosimilar products.
- Perform gap assessments of regulatory dossiers (Modules 2 and 3) and ensure that Health Canada regulatory requirements are met.
- Compile high quality product regulatory documents for new submissions/variations for various dosage forms to ensure timely approvals.
- Mentor and assist Associates in understanding new regulatory requirements and further build their regulatory skillset.
- Build strong relationship with Health Authorities, development partners and key stakeholders.

**What you’ll bring to the role**:
**Essential Requirements**:

- BSc in Pharmacy, Chemistry, Biochemistry, or related field.
- 5-8 years of direct experience pharmaceutical industry and in Canadian regulatory affairs, including successful dossier submissions to Health Canada.
- Very good knowledge of the MS Office Suite.
- Fluency in oral and written French is mandatory. Due to the nature of our operations, oral and written fluency in English is required for regular communication with customers, partners, and/or colleagues, whether in Canada or internationally.
- Excellent organizational skills including documentation and records management.
- Very good competency in the knowledge, understanding and interpretation of the submissions of the forms of Health Canada.
- Ability to prioritize multiple tasks, time management, and attention to detail.
- Strong customer focus, negotiation skills, and teamwork.
- Autonomous, very good initiative, oriented towards results and objectives.

**Desirable Requirements**:

- Knowledge of FDA, EMA requirements.
- Experience and/or interest in coaching.
- Experience in projects management.

**You’ll receive**:

- A minimum of three weeks’ vacation.
- Paid time off in addition to your annual vacation and statutory holidays.
- Time back between Christmas and New Year’s Day with full pay.
- Group pension plan with substantial employer contributions.
- Generous and flexible group insurance coverage through our private plan.
- Employee and family assistance.
- Telemedicine services.
- Parental leave - supplemental top-up payments up to 100% of base salary, regardless of gender or sexual orientation.
- Career enhancement and development, including learning, training and professional recognition opportunities.

**Why Sandoz?**:
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

The future is ours to shape

**Commitment to Diversity & Inclusion**:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

**Join our Sandoz Network**:
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: Sandoz Talentpool

**#Sandoz**

null
null

  • Associate, Regulatory Affairs, Operations

    4 months ago

    Boucherville, Canada Sandoz Full time

    As an **Associate, Regulatory Affairs, Operations **and part of a high-performing and inclusive team of regulatory experts, you will work on exciting projects that deliver affordable, quality medicines to patients every day. **Your Key Responsibilities**: Your responsibilities include, but not limited to: - Prepare and submit Safety Product Monograph...

  • Associate, Regulatory Affairs Bd&l

    4 weeks ago

    Boucherville, Canada Sandoz Full time

    As an **Associate, **Regulatory Affairs BD&L **and part of a high-performing and inclusive team of regulatory experts, you will work on exciting projects that deliver affordable, quality medicines to patients every day. **Your Key Responsibilities**: Your responsibilities include, but not limited to: - Gather and review all required documents for...

  • Regulatory Compliance Expert

    4 weeks ago

    Boucherville, Quebec, Canada Danone Full time

    This is a part-time Regulatory Affairs Specialist position with Danone, offering a unique opportunity to contribute to the growth of our business while ensuring compliance with Canadian regulations.As a key member of our team, you will play a crucial role in validating product labelling and supporting new product launches through regulatory advice. Your...

  • Associate, Regulatory Compliance

    4 months ago

    Boucherville, Canada Sandoz Full time

    As an **Associate, Regulatory Compliance **and part of a high-performing and inclusive team of regulatory experts, you will work on exciting projects that deliver affordable, quality medicines to patients every day. **Your Key Responsibilities**: Your responsibilities include, but not limited to: - Gather and review all required documents for preparation...

  • Associate, Regulatory Affairs

    2 weeks ago

    Boucherville, Canada Sandoz Canada Full time

    Job DescriptionEn tant qu’Associé(e), Affaires réglementaire BD&L et membre d'une équipe performante et inclusive d'experts réglementaires, vous travaillerez sur des projets passionnants qui fournissent des médicaments abordables et de qualité aux patients chaque jour.Vos Principales ResponsabilitésVos responsabilités inclus, mais ne se limitent...

  • Associate, Regulatory Competency Center

    2 months ago

    Boucherville, Canada Sandoz Full time

    As an **Associate, **Regulatory Competency Center **and part of a high-performing and inclusive team of regulatory experts, you will work on exciting projects that deliver affordable, quality medicines to patients every day. **Your Key Responsibilities**: Your responsibilities include, but not limited to: - Gather and review all required documents for...

  • Analyste en Accès Aux Marché Des Médicaments

    2 days ago

    Boucherville, Canada Groupe JAMP Pharma Full time

    N.B Le masculin est utilisé pour alléger le texte, et ce, sans préjudice pour la forme féminine. JAMP Pharma est une entreprise privée québécoise dont le siège social est situé à Boucherville, à 20 minutes de Montréal. La compagnie connaît une croissance phénoménale et figure parmi les principaux acteurs de l’industrie pharmaceutique...

  • Gestionnaire Des Finances, Contrat Commercial

    2 days ago

    Boucherville, Canada Groupe JAMP Pharma Full time

    N.B Le masculin est utilisé pour alléger le texte, et ce, sans préjudice pour la forme féminine. JAMP Pharma est une entreprise privée québécoise dont le siège social est situé à Boucherville, à 20 minutes de Montréal. La compagnie connaît une croissance phénoménale et figure parmi les principaux acteurs de l’industrie pharmaceutique...

  • Global Patient Safety Manager

    2 weeks ago

    Boucherville, Quebec, Canada Healthcare Businesswomen's Association Full time

    Job Title: Global Patient Safety Manager About the Role:We are seeking an experienced and skilled Global Patient Safety Manager to join our team at Healthcare Businesswomen's Association. This is a key role that will lead pharmacovigilance activities as the primary point of contact for Patient Safety. About the Job:The successful candidate will be...

  • Marketing Specialist

    7 months ago

    Boucherville, Canada Finloc 2000 inc. Full time

    **Description de l'entreprise** About Finloc 2000 Inc**: In business for over 45 years, Finloc 2000 Inc is a finance company specializing in the field of freight transportation equipment. Continually working to expand our expertise into other industries, we have developed a technology start-up called vHub/FinPark that aims to become the global truck sharing...

  • Mechanic and Maintenance Specialist

    4 weeks ago

    Boucherville, Quebec, Canada Penske Truck Leasing Full time

    About the JobWe are seeking a skilled Mechanic and Maintenance Specialist to join our team at Penske Truck Leasing. In this role, you will be responsible for performing preventative maintenance and repairs on our fleet of vehicles.Job ResponsibilitiesAs a Mechanic and Maintenance Specialist, your primary duties will include:Performing routine maintenance...

  • Clinical Safety Lead

    4 weeks ago

    Boucherville, Quebec, Canada Healthcare Businesswomen's Association Full time

    About UsAt the Healthcare Businesswomen's Association, we strive to make a positive impact on people's lives by providing innovative healthcare solutions.Salary Range$90,000 - $120,000 per annum, depending on experience and qualifications.Job DescriptionKey Responsibilities:Build strong relationships with cross-functional stakeholders in Canada, including...

  • Nurse Care Specialist

    4 weeks ago

    Boucherville, Quebec, Canada beBee Professionals Full time $45,000 - $65,000

    Job Title: Nurse Care SpecialistWe are seeking a compassionate Registered Practical Nurse to join our healthcare team in Canada.Responsibilities:Assess patients' needs and develop individualized care plans to ensure quality nursing services.Administer medications and treatments as prescribed by physicians, maintaining the highest standards of patient...

  • Payroll Specialist

    3 days ago

    Boucherville, Canada PPG Industries Full time

    As a **Payroll Specialist**, you will be working in Payroll Operations supporting Payroll Tax Filings, Payroll Accounting, Kronos Team and People Operations for Canada. You will work collaboratively with all aspects of People Operations on Payroll, Compensation, Benefits Administration, and other related technical and employee relations issues in a fast...

  • Patient Safety Lead

    4 weeks ago

    Boucherville, Canada Sandoz Full time

    As a **_Patient Safety Lead _**, you will lead pharmacovigilance activities as the primary and key internal and external point of contact in the affiliate for Patient Safety. **Your Key Responsibilities**: Your responsibilities include, but not limited to: - Build strong relationships with cross-functional stakeholders in Canada, including regulatory...

  • Spécialiste en Marketing

    7 months ago

    Boucherville, Canada Finloc 2000 Inc Full time

    **Spécialiste en Marketing** Poste permanent, temps plein Basé à Saint-Georges de Beauce ou Boucherville **À propos de Finloc 2000 Inc**: En affaires depuis plus de 45 ans, Finloc est une société de financement spécialisée dans le domaine des équipements de transport de marchandises. Travaillant continuellement à étendre notre expertise à...

  • Communication Specialist, Corporate Affairs

    6 months ago

    Boucherville, Canada Sandoz Full time

    Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. _ - Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its...

  • Personal Banking Associate

    4 months ago

    Boucherville, Canada BMO Financial Group Full time

    1001 boul Montarville, Unit 34 Boucherville Quebec,J4B 6P5 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...

  • Conseiller(ère) à La Clientèle

    6 months ago

    Boucherville, Canada BMO Financial Group Full time

    1001 boul Montarville, Unit 34 Boucherville Quebec,J4B 6P5 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...

  • Customer Service Representative

    7 months ago

    Boucherville, Canada BMO Financial Group Full time

    1001 boul Montarville, Unit 34 Boucherville Quebec,J4B 6P5 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...