Senior Cmc Specialist - Aubenas, France - Bausch + Lomb

Bausch + Lomb

Entreprise vérifiée

Aubenas, France

il y a 2 semaines

Posté par:

Sophie Dupont

beBee Recruiter

Description

Bausch + Lomb is hiring

Bausch + Lomb have brought visionary ideas to eye health since 1853.

With products available in more than 100 countries worldwide, Bausch + Lomb offers the world's most comprehensive portfolio of eye health products to consumers and eye care professionals.

The Global Regulatory CMC Bausch + Lomb team plays a critical role as part of the strategy for Bausch+Lomb. For this reason, we are currently recruiting for a Senior CMC Specialist m/w.

Purpose:

The CMC Senior Specialist independently manages all regulatory CMC aspects of our products throughout their lifecycle.

He/she is responsible for the regulatory CMC strategies of all submissions for products under his/her responsibility as well as managing interactions with regulatory authorities on CMC issues.

The Specialist is the first point of contact for all concerned products, which includes also the corresponding contact to the Regulatory Affairs Product Leads group.

He/she has the functional responsibility for the Berlin site ́s personnel who is responsible for these products.

Reports to:
Head, Global Regulatory CMC, EMEA (located in Berlin)

Main tasks:

As part of the European CMC team, you will be in contact with the local Regulatory Affairs team and the production site members on the following activites:

Formulate, lead and drive CMC regulatory strategy for development projects or marketed products with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance.

Proactively communicate CMC regulatory strategy, key issues and any other critical topics throughout the life cycle to interdisciplinary project teams and to appropriate management level in Regulatory Affairs, R&D, TechOps and Supply Chain as appropriate in a timely manner.

Lead and drive all CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products. Make quality regulatory decisions, balancing risks and benefits.

Identify as early as possible, the required documentation and any content, quality and/or timeline issues. Negotiate the delivery of approved technical source documents in accordance with project timeline.

Coordinate with Regulatory Operations to ensure timely and accurate submissions to Regulatory Authorities.

Manage interactions with authorities on CMC issues.

Provide regulatory support to other company functions during Regulatory Authority inspections.

Serve as Regulatory Affairs representative on facility/site Local Change Management Boards.

Participate in assigned due diligent business activities.

Review and provide input on proposed health authority guidance documents on CMC issues.

Coordinate in a timely manner assigned projects and tasks including supervision of CMC team responsible for Aubenas ́ products.

Profile:

Experience in the pharmaceutical industry with multi-annual experience in the CMC field

Scientific educational background (Pharmacy, Master Degree in Chemistry, Food chemistry, Biology etc.)

Organizational talent as well as reliable and structured work style

High precision combined with goal orientation

Good abilities in description of complex circumstances

High abilities in teamwork and communication skills

Fluent in English and French

Location:
Montpellier, France

Travels:
around 10%, our French production site is located in Aubenas (Ardèche)