Dieses Jobangebot ist archiviert und steht nicht mehr zur Verfügung.
Vakante Jobangebote finden Sie unter Projekte.

GPRM/Regcmc Manager Junior (Ref. Nr. RE2524)

Eingestellt von BRINE SA

Gesuchte Skills: Consultants, Sap

Projektbeschreibung

BRINE SA has been placing top IT specialists at well-known customers for over 30 years. In doing so, we focus on performance, competence, experience and partnerships.

For one of our customers in Basel, we are looking for a JUNIOR GPRM/REGCMC MANAGER.

JOB PURPOSE:

Under supervision, provide strategic and operational global CMC regulatory direction and documentation for projects/products covering development, registration and approval/post approval activities.

EXPERIENCE

-

Minimum 2 years in regulatory preferred, and/or experience in drug/biopharmaceuticals
-

Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology.
- Knowledge of the drug development process desirable. Ability to critically evaluate data from a broad range of scientific disciplines.
-

Demonstrated track record to successfully work in interdisciplinary teams, planning, coordinating, leading activities simultaneously on multiple projects.
-

Knowledge/experience of regulations, guidelines for NCEs and product life cycle maintenance desirable.
-

Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload.
-

Effective planning, organizational and interpersonal skills.
-

Reasonable approach to risk assessment.
-

Excellent written/spoken communication and negotiation skills.
-

Computer literacy.

MAIN RESPONSIBILITIES

-

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 -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.

-

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.
-

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.
-

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.
-

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.
-

Initiate and lead Health Authority interactions and negotiations as appropriate; setting objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans.
-

Lead and drive cross-functional CMC Health Authority Response Teams (HARTs) for assigned development projects and/or marketed products, and prepare CMC responses, as appropriate.
-

Prepare and communicate CMC risk management assessments (RMA), contingency plans, and Lessons Learned exercises on major submissions with sub teams and escalate with management as appropriate.
-

Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.
-

Assume specialized assignments as assigned and represent own department in cross-functional project teams.
-

Represent own department at Global Supply Support Teams (SST), Regulatory review boards and other teams and boards as appropriate.

EDUCATION

-

Minimum: Degree in Science (eg Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
-

Desirable: Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent.

LANGUAGE

English: Fluent (oral and written)

German: Good (oral)

WORK LOCATION: Basel

START: ASAP

DURATION: 1 year

WORKLOAD: 100%

SALARY: Local Market rate according to experience

LANGUAGE: English, German

REF: RE2524

To learn more about this opportunity please send your CV ASAP in Word format to Brine SA

BRINE SA has been providing its IT- and SAP specialists for short-, mid- and long-term projects in Switzerland since 1985, with customers primarily active in the following market sectors:

Financial services sector, especially banks and insurance companies

Pharmaceutical industry

Government and services sectors

BRINE SA is a stable, financially independent, Swiss enterprise with its head office in Zurich. Our services cover the entire IT spectrum, as well as interfaces to the various business sectors, and range from management- and IT-consulting through to software development and project implementation.

IT - RESOURCES

We offer our top consultants, computer Profi's and SAP experts to our customers as external specialists for limited assignments and as well for permanent positions. BRINE SA is especially distinguished by its renowned characteristic strengths:

Short reaction time - rapid selection and supply of consultant's CVs, with skills matched to customer requirements.

Quality - we take quality very seriously, both for internal and external-facing processes, thereby convincing many customers to maintain a long-standing business relationship with BRINE SA

Coaching - BRINE SA coaches and supports its consultants throughout the entire duration of the customer assignment.

BRINE SA is ISO 9001:2008 certified since 2014

Projektdetails

  • Einsatzort:

    Basel, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    1 Year

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    SAP Entwicklung, Organisation/Management

  • Skills:

    consultants, sap

BRINE SA