Job Description

About us: 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 an exciting new opportunity for a Manager, Regulatory Affairs to join our North American team.The Role: This role requires a strong knowledge of the drug development process, regulatory affairs, and/or other regulatory functions and requires an ability to work independently with minimal supervision and a quality approach to documentation and an eye for detail. This role may also include the use of specific client operating systems.
Responsibility for regulatory activities including, but not limited to:

• approvals of NDS/Variations and maintenance,
• marketing authorization transfers,
• communication with various Health Authorities
• artwork approval,
• ensuring regulatory compliance in the applicable market(s).

• Performing and undertaking regulatory tasks in either Regulatory Strategy (which could include filing of NDS, aNDS, CTA, MAH, coordinating renewals and variations, labelling changes, artwork approval); CMC (pre- and post-approval maintenance) or Regulatory Operations/Submission Management projects independently.
• In addition to working to strict industry and client guidelines, the job holder will be expected to use their initiative to continually develop their own knowledge and skills.
• Working as part of a team, the job holder will be expected to support colleagues to achieve results.
• Managing local regulatory submission preparation in collaboration with internal and external stakeholders based on the agreed strategy for designated countries.
• Preparing and delivering submissions including renewals/variations/new applications filings/MAH transfers to the local Health Authority and following up on the local regulatory approval process for designated countries.
• Preparing of local Product Labelling (e.g. SmPC, PIL), in local language for designated countries.
• Reviewing Artwork and approvals in client systems.
• Reviewing promotional materials and approving them in client systems.
• Managing multiple pharmaceutical products.
• Acting as a subject matter expert in regulatory processes.
• Keeping up to date on latest local pharmaceutical legislation, relevant guidelines and requirements.
• Performing other tasks or assignments, as delegated by Regulatory management.
• Managing meetings with Regulatory Agencies.
• Performing other duties, as business needs require.

Candidate Requirements:

• Bachelor's Degree in Pharmacy, Life Sciences, or professional equivalent.
• 5-7+ years regulatory expertise in country-specific requirements for medicinal products including the supervision and creation of country-specific regulatory submission documents and coordinating delivery to submission plans, artwork review, communication with the Health Authority.
• Excellent written and verbal communication skills in English and French are essential.
• Experience with working in a large regulatory organization where some tasks are managed centrally and some at a local level.
• Knowledge of local pharmaceutical legislation, relevant guidelines and requirements.
• Excellent regulatory project management skill set.
• Regulatory technology experience is a benefit.
• Excellent organization and communication skills.
• Ability to work to tight timelines.
• Good team player.
• Strong computer skills, including MS Office applications, and preferably, experience with Regulatory Information management and artwork systems.
• Ability to perform the job in accordance with the G&L and clients Quality Systems and Procedures, including the Equal Opportunities and Harassment Policy.

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 Type: PermanentBenefits:

• Company pension
• Dental care
• Disability insurance
• Extended health care
• Life insurance

Schedule:

• Monday to Friday

Education:

• Bachelor's Degree (preferred)

Experience:

• Regulatory Affairs: 5 years (required)

Language:

• French and English (required)