Regulatory Affairs and Compliance Associate

**POSITION SCOPE**:
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 & 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.
- 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 in terms of standing, walking, lifting, keyboarding, pushing, pulling, sitting, packing, assembling, bending or twisting; includes moderate fine or coarse movements.

**Material Resources**:High level of consequence and costs associated with errors as related to losses of time, money, or property; high responsibility for significant machinery, work aids, equipment, materials, properties, products, stock, inventory or tools.

**Information Resources**: High level of consequence and costs associated with quality errors as related to losses of time, money or property; moderate responsibility for information and or services; regular access to confidential, sensitive or proprietary information.

**People/Policies/Practices**: Quality assurance responsibility for people, policies or practices in terms of assuring compliance in accordance to company policies. Regularly demonstrates work practices to others or is required to influence others to achieve output goals; overall responsibility for departmental output.

**Financial Resources**:Regular responsibility for financial data, money or financial transactions, budget management financial recor