Regulatory Affairs Associate

4 weeks ago

Toronto, Canada Apollo Health And Beauty Care Full time

Apollo Health & Beauty Care (Apollo) is a premium developer of private label and control label health & beauty care products and leverages unique expertise and experience in developing national brand-equivalent products designed to compete equivalently with the most popular national brands. The largest private label and control label personal care manufacturer in Canada, Apollo has formidable penetration and distribution in the North American marketplace and also services customers throughout Central and South Asia, Mexico, Europe and Asia. Building on our core values of Excellence and Commitment, Apollo has established itself as a market leader that attracts the industry's top talent. We are currently searching for an energetic, motivated _**_Regulatory Affairs Associate _**_to join our Team_

***:

- The Regulatory Affairs and Compliance Associate participates in the project management and maintenance of regulatory licensing, new product launch, label review and post-market surveillance responsibilities in support of the development and lifecycle of Apollo products.

**RESPONSIBILITIES AND DUTIES**:

- Point of contact and accountability for regulatory affairs and management of third-party Regulatory Affairs provider. Manages quality agreements and NDAs.
- Functions as the global regulatory lead for assigned projects, working with the external Compliance to form a virtual Global Regulatory Team, including Operations, Labeling, Advertising/Promotion and other functions as required to drive global regulatory strategies.
- Provides proactive guidance to internal groups based on technical and regulatory knowledge towards the development of strategic and tactical plans for change management involving new product launch.
- Identify and assess the regulatory risks associated with product development for assigned projects.
- Manages submission activities of regulatory documents, e.g., NPNs, NDCs, DINs, PIFs, no change notifications, HC/EPA/FDA Establishment Licenses, Biosecurity and HPTA Licenses, NHP site licence, Cosmetic notification, voluntary cosmetic reporting program, import/export/free sale/toxic control act/BCB certificates, SDSs, and other relevant regulatory filings.
- Reviews all labels for regulatory and customer quality compliance.
- Assessing all complaints and Handling, Evaluating and Reporting of Adverse Drug Reactions complaints
- Manage Apollo’s Pharmacovigilance (PV) activities.
- Generate Annual Safety Reports for Apollo’s OTC products from Solicited and Unsolicited study, literature, and regulatory databases.
- Manages Supplier’s qualification and quality agreements
- May serve as a corporate liaison with regulatory Health Authority (HA) agencies to develop effective professional relationships as well as our positive company image.
- Can effectively lead key meetings with Formulations Development to ensure full discussion of issues and opportunities.
- Provides guidance to all appropriate departments to assure compliance with applicable regulations.
- Remains knowledgeable about current regulations and guidance and interprets and notifies appropriate personnel.
- Responsible for creating and reviewing regulatory SOPs

**JOB SPECIFICATIONS**:
**KNOWLEDGE/EDUCATION/EXPERIENCE**: 5+ years of GMP-related experience in biopharmaceutical or pharmaceutical manufacturing facilities. Bachelor’s degree or diploma in Chemistry, Biology, Engineering or related field; thorough knowledge of cGMP/GDP international regulatory compliance in addition to Regulatory/Operations experience in a GMP environment; ability to prioritize daily activities in order to meet internal and external customer needs in a fast-paced environment; ability to work on Quality projects where analysis of data requires evaluation of identifiable factors.

**INTERPERSONAL SKILLS/CONTACTS**: Regular access to confidential or sensitive information; frequent and regular internal interactions and frequent external interactions; purpose of internal/external contacts is regularly related to complex matters and may have high levels of consequence and costs associated with errors; occasional selling, negotiating, consulting, teaching/instructing, or advising; above average level of written and verbal communication skills required for successful job performance.

**PROBLEM SOLVING/JUDGMENT**: Position has significant amount of autonomy in terms of level of monitoring and decisions generally do not follow prescribed guidelines; regular and frequent analysis required; regularly and frequently makes recommendations or referrals; responsible for frequently solving complex technical problems or personnel issues.

**MENTAL EFFORT**: Requires high levels of concentration and/or attentiveness; sustained duration and/or intensity of efforts; requires high levels of thinking, watching, listening, verifying, checking numbers, creating or designing.

**PHYSICAL EFFORT**: Occasional duration or intensity of physical effort; moderate energy required

  • Regulatory Affairs Associate

    4 weeks ago

    Toronto, Canada Mundipharma Full time

    Company Description - Elvium Life Sciences focuses on our existing products in the areas of CNS (ADHD), cancer supportive care, and ophthalmic conditions while continuing to advance on research and enhance treatment options for Canadians. **Job Description**: - We are looking for a Regulatory Affairs Associate to join our team at the Elvium Life Sciences...

  • Regulatory Affairs Associate

    4 weeks ago

    Toronto, Canada Translational Research in Oncology Full time

    Translational Research in Oncology (TRIO) is a global academic clinical research organization dedicated to advancing translational cancer research in the clinical trial setting. Our passionate team is committed to providing cancer treatments of the future to the world of today. TRIO is looking for a **Regulatory Affairs** **Associate to** join...

  • Regulatory Affairs Associate

    3 days ago

    Toronto, Canada Nora Pharma Full time

    Regulatory Affairs Associate - Permanent Full Time (Remote) Nora Pharma is a Canadian pharmaceutical company specializing in the distribution of generic drugs across the country. The company offers a range of generic products and related services to ensure customer satisfaction. Position Overview: We are seeking a motivated and experienced Regulatory...

  • Regulatory Affairs Associate

    3 days ago

    Toronto, Canada Nora Pharma Full time

    Regulatory Affairs Associate - Permanent Full Time (Remote) Nora Pharma is a Canadian pharmaceutical company specializing in the distribution of generic drugs across the country. The company offers a range of generic products and related services to ensure customer satisfaction.Position Overview: We are seeking a motivated and experienced Regulatory Affairs...

  • Regulatory Affairs Associate

    3 days ago

    Toronto, Canada Nora Pharma Full time

    Regulatory Affairs Associate - Permanent Full Time (Remote) Nora Pharma is a Canadian pharmaceutical company specializing in the distribution of generic drugs across the country. The company offers a range of generic products and related services to ensure customer satisfaction.Position Overview: We are seeking a motivated and experienced Regulatory Affairs...

  • Associate Director, Regulatory Affairs

    1 week ago

    Toronto, Canada Johnson & Johnson Full time

    Johnson & Johnson Innovative Medicine is recruiting for an Associate Director, Regulatory Affairs, to be located in Toronto, Ontario, under the flexible working model (at least 3 days in office).At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented,...

  • Associate Director, Regulatory Affairs

    7 days ago

    Toronto, Canada Johnson & Johnson Full time

    Johnson & Johnson Innovative Medicine is recruiting for an Associate Director, Regulatory Affairs, to be located in Toronto, Ontario, under the flexible working model (at least 3 days in office).At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented,...

  • Associate Director, Regulatory Affairs

    1 week ago

    Toronto, Canada Johnson & Johnson Full time

    Johnson & Johnson Innovative Medicine is recruiting for an Associate Director, Regulatory Affairs, to be located in Toronto, Ontario, under the flexible working model (at least 3 days in office).At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented,...

  • Associate Director, Regulatory Affairs

    7 days ago

    Toronto, Canada Johnson & Johnson Full time

    Johnson & Johnson Innovative Medicine is recruiting for an Associate Director, Regulatory Affairs, to be located in Toronto, Ontario, under the flexible working model (at least 3 days in office).At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented,...

  • Senior Associate Regulatory Affairs

    4 days ago

    Toronto, Canada Attaineo Full time

    Reporting to the Regulatory Affairs Director, the Senior Associate Regulatory Affairs will prepare regulatory submissions for complex injectable generic products and biosimilars; and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory requirements. The Senior Associate Regulatory Affairs will...

  • Associate Director, Regulatory Affairs

    2 weeks ago

    Toronto, Canada Johnson & Johnson Full time

    Apply NowApply NowSaveSavedOpen sharing optionsShareDescriptionJohnson & Johnson Innovative Medicine, is recruiting for an Associate Director, Regulatory Affairs, to be located in Toronto, Ontario, under the flexible working model (at least 3 days in office).At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers...

  • Regulatory Affairs Associate- Contract

    3 weeks ago

    Toronto, Canada Colgate-Palmolive Full time

    No Relocation Assistance Offered 162652 - Toronto, Ontario, Canada **Who We Are** Colgate-Palmolive Company is a caring, innovative growth company that is reimagining a healthier future for all people, their pets and our planet. Focused on Oral Care, Personal Care, Home Care and Pet Nutrition, we sell our products in more than 200 countries and territories...

  • Regulatory Affairs and Compliance Associate

    1 week ago

    Toronto, Canada Apollo Health And Beauty Care Full time

    Apollo Health & Beauty Care (Apollo) is a premium developer of private label and control label health & beauty care products and leverages unique expertise and experience in developing national brand-equivalent products designed to compete equivalently with the most popular national brands. The largest private label and control label personal care...

  • Associate Director, Regulatory Affairs

    4 weeks ago

    Toronto, Canada Johnson & Johnson Full time

    Johnson & Johnson Innovative Medicine is recruiting for an Associate Director, Regulatory Affairs to be located in Toronto, Ontario under the flexible working model (at least 3 days in office). For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day....

  • Associate Director, Regulatory Affairs

    1 week ago

    Toronto, Canada Johnson & Johnson Full time

    Johnson & Johnson Innovative Medicine, is recruiting for an Associate Director, Regulatory Affairs, to be located in Toronto, Ontario, under the flexible working model (at least 3 days in office). For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every...

  • Regulatory Affairs Lead

    6 days ago

    Toronto, Ontario, Canada Medison group Full time

    Job OverviewAs a Senior Associate in Regulatory Affairs at Medison Group, you will play a critical role in developing and implementing the Canadian regional preclinical, clinical, and CMC regulatory strategy for products in development and/or post NDS approval.Key Responsibilities:Developing and implementing regulatory strategies in collaboration with the...

  • Regulatory Affairs Strategist

    6 days ago

    Toronto, Ontario, Canada Medison group Full time

    Job DescriptionAs a Senior Associate in Regulatory Affairs at Medison Group, you will play a key role in developing and implementing the Canadian regional preclinical, clinical, and CMC regulatory strategy for products in development and/or post NDS approval.Key Responsibilities:Lead the planning, coordination, and preparation of regulatory submissions and...

  • Regulatory Affairs Specialist

    2 weeks ago

    Toronto, Canada McCain Foods Full time

    **Position Title**: Regulatory Affairs Specialist **Position Type**: Regular - Full-Time **Position Location**: Toronto HQ ; Florenceville-Bristol, New Brunswick, Canada **Grade**: Grade 04 **Requisition ID**: 32400 **Position Summary**: The Regulatory Affairs Specialist is responsible for product composition and label regulatory compliance for finished...

  • Regulatory Affairs Specialist

    2 weeks ago

    Toronto, Canada McCain Foods Limited Full time

    **Position Title**:Regulatory Affairs Specialist **Position Type**: Regular - Full-Time **Position Location**: Toronto HQ ; Florenceville-Bristol, New Brunswick, Canada **Grade**: Grade 04 **Requisition ID**: 32400 **Position Summary**: The Regulatory Affairs Specialist is responsible for product composition and label regulatory compliance for finished...

  • Regulatory Affairs Leader

    6 days ago

    Toronto, Ontario, Canada Johnson & Johnson Full time

    Job Summary:We are seeking a seasoned Regulatory Affairs professional to lead our compliance efforts in Canada. As Director, Regulatory Affairs, you will be responsible for ensuring that all regulatory activities are conducted in accordance with Canadian laws and regulations, as well as corporate policies and procedures. Your primary focus will be on...