Junior GPRM/Reg. CMC Manager

JUNIOR GPRM REGULATORY CMC MANAGER

DURATION: 1 YEAR
LOCALISATION: BASEL
WORKLOAD: 100%

You are an expert in regulatory affairs specialist ideally with knowledge of CMC regulation? Your profession is your passion? You're a problem solver who is looking for a new challenge? Great!

Our client, an international pharmaceutical company, is looking for you!

Under supervision, you provide strategic and operational global CMC regulatory direction and documentation for projects covering development, registration and approval activities

THESE ACTIVITIES INCLUDE:

1.Formulate and lead global CMC regulatory strategy for development projects or marketed products with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance
2. Proactively communicate CMC regulatory strategy, key issues and any other critical topics throughout the life cycle in an adequate and timely manner to interdisciplinary project teams and to appropriate management level in regulatory, technical development, and technical operations departments as appropriate.
3. Lead and implement all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products, while applying the global strategy into submissions. Make quality regulatory decisions, balancing risks and benefits.
4. As early as possible, identify the required documentation and any content, quality and/or timeliness issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
5. Author high-quality CMC documentation for HA submission, applying CMC global regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements.
6. Establish and maintain a single point of contact with FDA or country affiliates, RA regional and TA groups for all communication on development and marketed products. Establish and maintain sound working relationships with partners and customers.
7. Initiate and lead Health Authority interactions and negotiations as appropriate; setting objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans.
8. Lead and drive cross-functional CMC Health Authority Response Teams (HARTs) for as-signed development projects and/or marketed products, and prepare CMC responses, as appropriate.
9. Prepare and communicate CMC risk management assessments (RMA), contingency plans, and Lessons Learned exercises on major submissions with subteams and escalate with management as appropriate.
10. Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.
11. Assume specialized assignments as assigned and represent own department in cross-functional project teams.
12. Represent own department at Global Supply Support Teams (SST), Regulatory review boards and other teams and boards as appropriate.

YOUR PROFILE:
Education
Minimum: Degree in Science (eg Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
Desirable: Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent.
Languages: Fluent English required (oral and written).
Good skills in site (local) language desired (oral) (German)

EXPERIENCE/PROFESSIONAL REQUIREMENT:
1. Minimum 2 years in regulatory preferred, and/or experience in drug/biopharmaceuticals
2. Working knowledge of chemistry/biotechnology, analytics or pharma-ceutical technology. Knowledge of the drug development process desirable. Ability to critically evaluate data from a broad range of scientific disciplines.
3. Demonstrated track record to successfully work in interdisciplinary teams, planning, coordinating, leading activities simultaneously on multiple projects.
4. Knowledge/experience of regulations, guidelines for NCEs and prod-uct life cycle maintenance desirable.
5. Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload.
6. Effective planning, organizational and interpersonal skills.
7. Reasonable approach to risk assessment.
8. Excellent written/spoken communication and negotiation skills.
9. Computer literacy.

We offer you a competitive salary and an interesting challenge in a well named company which will benefit your career.

If you are the person we're looking for please submit your application. We're looking forward to getting to know you. Please send your complete CV in English.