Biopharma Cmc Regulatory Affairs Consultant

2 weeks ago

Canada G&L Scientific Inc. Full time

G&L Scientific is the world’s fastest-growing independent scientific consultancy providing Pharmaceutical and Biotechnology clients throughout the world with expert Regulatory Affairs consultancy and Quality Assurance solutions.

As demand for our services and solutions continues to increase, we have multiple openings in our global team for Regulatory Affairs professionals with Biopharma CMC experience.

**The Role**:

- Life cycle management for pharmaceutical, biologics or vaccine products.
- Working in global regulatory affairs, particularly EU and Asia Pacific regions, including working on evolving and emerging trends and new policies.
- Potentially supervising and training junior staff within G&L’s organisation.
- Preparing a variety of CMC regulatory documents.
- Working with manufacturing sites on change control projects; providing regulatory advice and strategic guidance.
- Managing multiple projects simultaneously; provide data assessment and conclusions.
- Identifying risks associated with submission data and information packages and then proposing mitigation plans.
- Efficiently interacting with G&L’s clients and internal stakeholders as required.
- Identifying improvement opportunities for CMC Regulatory processes, policies and systems.
- Contributing to process improvement and regulatory intelligence projects.

**Required Skills**:

- 5-10 years working experience in Post Approval CMC.
- Previously experience working for a consultancy company would be a benefit.
- Biopharma experience, ideally across multiple therapy areas.
- CMC authoring experience essential (previous coordination role is not sufficient), including authoring module 3 and CMC variations.
- Impeccable communication skills and flexible approach; diplomacy and negotiating skills.
- G&L Scientific is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status or race._
- We recruit based on talent alone and firmly believe that an individual’s background should play no part in the recruitment and selection process._
- G&L is committed to everyone having the right to work in an environment free from the threat of discrimination, intimidation, harassment, and abuse._
- All employees at G&L share the responsibility to challenge discriminatory behaviour and promote equality of opportunity._

**Job Types**: Full-time, Permanent

Schedule:

- Monday to Friday

**Experience**:

- Post Approval CMC: 5 years (required)
- CMC module 3 authoring and CMC variations: 2 years (required)
- biologics/vaccine products: 1 year (required)

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