Regulatory Affairs Associate

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_

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- 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