Regulatory Affairs Manager

In this vital role you will provide expertise in translating chemistry, manufacturing and control (CMC) regulatory requirements into practical, workable plans.

The primary responsibilities of this role are to support the planning and execution of the site-specific aspects of the preparation of CMC sections for new marketing applications, and post-market supplements and preparation CMC sections of annual reports of minor changes for specific products.

You will also act as key Regulatory Affairs (RA)-CMC representative for managing change control, deviations and serve as the point of contact for communications with business partners and global regulatory authorities for requests related to the site.

Specific responsibilities include but are not limited to:

• Support the develop and implementation of regulatory strategies as they relate to changes at the site.

• Lead submission process for site initiatives

• Provide strategic expertise regarding regulatory requirements for manufacturing related projects.

• Collaborate with Regulatory Authorities as appropriate and in coordination with Global and International representatives.

• Support regulatory authority inspections as required by Site Quality Compliance.

• Serve as RA - CMC representative on Cross Functional Teams.

• Lead or collaborate in the creation site related regulatory components for global submissions.

• Support the generation of facility and GMP related documents to be used in product registrations activities.

• Review and approve regulatory documents.

• Review and assess the regulatory impact of proposed manufacturing related changes, deviations and other GMP related documents.

• Maintain facility related files.

• Develop and maintain regulatory awareness through meetings, conferences and regulatory contacts.