Regulatory Affairs CMC Expert (M/F)

Job description

Regulatory Affairs CMC Expert (M/F)Job Description - Regulatory Affairs CMC Expert (M/F) (170009MW)

Job Description

Regulatory Affairs CMC Expert (M/F)(

Job Number:

170009MW)

Description

Nestlé Skin Health is a global leader in improving the quality of life by delivering innovative medical solutions for the health of skin, hair and nails throughout people's lives. Nestle Skin Health aims to meet the needs of healthcare professionals and consumers through constant innovation in technology and products to protect and improve the health of the skin and treat skin diseases.

Nestlé Skin Health is a subsidiary of Nestlé.

For our Global SIG Rx organisation, we are currently looking for:

Regulatory Affairs CMC Expert (M/F)

Based in the Lausanne region of Switzerland, in an innovative and dynamic environment, you will be attached to the Head of Regulatory Affairs CMC and will be:

The RA CMC expert is responsible for preparing and updating the CMC sections of assigned products (Rx or non-monograph OTC drugs). Support the RA Managers for regulatory strategy of development and commercial products. Prepares CMC sections for investigational and commercial products (IMPD, IND, MAA, NDA, ...). Establishes data requirements for CMC changes with Pharmaceutical Experts and Operations (MTO) teams. Follows new CMC activities from initial project plan, dossier preparation, support for registration and confirmation of revised status.

Activities and responsibilities :

Main Responsibilities:

Writes/assembles pharmaceutical sections of Investigative Product CMC sections.

Writes/assembles CMC sections of registration dossier for Rx and non-monograph OTC drugs.

Prepares responses to Questions from Competent Authorities, if needed.

Advise/validate regulatory feasibility and strategy of proposed CMC modifications with Pharmaceutical Experts and Operations (Change control)

Reviews data provided to support updates/variations; prepares variation dossiers, supports registration and communicates final outcome.

Ensures all CMC dossiers are stored in the company database and are kept current.

Responsible for management of the service provider contracted to support a project, if appropriate.

Quality :

Prepare SOPs, forms, etc. to describe processes in the team.

Propose/participate in improvements to processes to improve efficiency and to ensure continued compliance with applicable regulations.

Regulatory :

Monitor internal and professional communications concerning relevant regulations (ICH, GMP, …)

Propose/participate in steps required to maintain regulatory compliance

Expected qualifications :

BSc, MSc in a scientific discipline or Pharmacist

3 to 5 years in a Pharmaceutical Company in a Pharmaceutical Development, Quality or Regulatory Compliance Departments, as well as 2 years CMC Regulatory experience.

Experience with systemic drugs (Biologics);

Focused on effective delivery of objectives, even when working with tight deadlines;

Planning, organising and time management skills;

Problem solving and analytical skills;

Ability to identify opportunities/major issues and to communicate impact;

Demonstrated ability to deal with rapid change;

Effective verbal and written communication skills in a cross functional environment;

Fluent in English

Location: Lausanne Region, Switzerland.

Date: As of Q3 2018

Primary Location

: Switzerland-VD-Lausanne

Job

: Regulatory Affairs

Organization

: Galderma

Schedule

: Full-time

Job Posting

: May 23, 2018, 4:09:03 AM