Regulatory Affairs Manager - CMC

Job Description

12 month contract

1.0 FTE

Applicants MUST be based in Belgium to be considered for this role

Scope of work
Execution of European Regulatory CMC strategies, submissions and compliance activities for biopharmaceutical projects/products from development to market and post-marketing, including the preparation and submission of correspondence and applications (IMPD's, MAA's…) to regulatory agencies.

Potential project responsibilities may include monoclonal antibodies, other recombinant proteins, vaccines, peptides and nucleotides.

Depending on experience, may act as CMC liaison with regulatory authorities to discuss and define submission contents and strategies.

Preparation of CMC information for submission to EU regulatory agencies, generates CMC strategies, assesses risks and develops contingency plans.

Ensures that CMC regulatory submissions are complete, properly formatted, and comply with applicable regulatory requirements.

Support preparation of interfaces with Boards of Health, including scientific reviewers, administrative staff… in order to discuss and define regulatory applications (Quality Module, Responses, Commitments.

Depending on experience, may act as CMC representative in formal meetings and teleconferences with regulatory authorities.

Life Cycle Teams and compliance of commercial products.

May operate independently to resolve issues and manage regulatory risks and ambiguous situations within project teams.


Experience
Scientific degree in a relevant subject (minimum PharmD or science related BSc or MSc)

An experienced regulatory CMC professional or an individual with regulatory expertise in pharmaceutical science development and/or biopharmaceutical manufacturing and/or specific regulatory domain (3-5 years prior international regulatory with experience in CMC or in Quality Assurance).

Ability to interpret and apply global / regional CMC regulatory policies and requirements for assigned projects.

Consultant is required to have a broad functional knowledge of pharmaceutical sciences / the Biopharmaceutical industry, with a clear understanding of drug development/commercial manufacturing of biopharmaceuticals.

Consultant is required to have a recognized demonstration of

• Leadership skills, influencing and persuading skills
• Excellent cross-cultural awareness and understanding
• Fluency in the English Language is essential
• Excellent communication, interpersonal and relationship building skills

We will take into consideration all level of experience.

In the past the proposals selected for that kind of project had a least 5 year's experience.

MANDATORY :

(1) CMC experience

(2) Bio background

(3) Scientific background

University degree, Scientific (chemical, biochemical)

Operational services - Min. 2 years of relevant experience in Biotechnical - Vaccines

International Regulatory experience for full registration Vaccines dossiers (not local experience).

Main responsibilities

International Regulatory experience for full registration Vaccines dossiers (not local experience).

OPERATIONAL ROLE

Coordination of all steps of registration process (not strategic)

Area concerned is the rest of the world (not US - not Europe - not Japan)

Compilation of files following local regulatories + follow-up + maintenance for Vaccines -

Only contact he/she will have is internally (with the affiliates) - RA Support - works independently

University degree, Scientific (chemical, biochemical)

Languages needed and level

ENG

Does this person need to drive (remote site - no public transport)

No

Location

La Plaine - Brussels (Ixelles)