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Associate Director, Regulatory Affairs - Swiss-Biotech

Employer
Planet Pharma Staffing Limited
Location
Switzerland
Salary
Competitive package
Start date
9 Aug 2019
Closing date
8 Sep 2019

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Job Details

THE ROLE

The Regulatory Affairs, Associate Director supports regulatory objectives, advice and strategy in alignment with Regulatory department and strategic corporate goals. You will work with cross-functional teams to ensure regulatory requirements are achieved for a range of products.

You will be the official liaison with EU Regulatory Agencies and will support preparation and conduct of meetings with EU Regulatory Agencies. You will plan and manage regulatory document preparation for regulatory submissions in Europe and in International geographies including CTAs, MAAs, Variations, Orphan applications, PIPs.

RESPONSIBILITIES

The Associate Director will be responsible for ensuring that the company is developing and executing optimal regulatory strategies for Europe and other international locations. The will also be responsible for preparing and supporting interactions with regulatory authorities appropriately.

• Develop and lead globally aligned regulatory strategies for small molecule and biologics. Activities include Scientific Advice, Orphan Drug Designations, paediatric plans, registration procedures to optimize successful regulatory review and approval

• Review and interpret regulatory correspondences for global project teams

• Provide regulatory support to inter-departmental project teams and interact proactively with other functions, CRO’s, partner companies, and health authorities

• Prepare and support company functions for interactions with regulatory authorities and for regulatory submissions

• Work with global regulatory team to agree contents for timely submissions to Health Authorities

• Plan and lead the preparation, review, and approval of compliant regulatory documents for European and International CTA and MAA submissions throughout the product lifecycle

• Ensure that data provided are presented clearly and succinctly to optimize the regulatory review and approval process

• Coordinate the preparation of responses to questions and inquiries from Health Authorities. Prepare and submit CTA amendments, DSUR and MA Renewal in accordance with regulatory submission schedules and regulations.

• Work with Regulatory Operations group to ensure preparation of dossiers containing preclinical, clinical, and technical data in the required eCTD format

• Ensure accurate retention in the archival system of all regulatory submissions and contacts with health authorities

• Coordinate and support regulatory activities with affiliates and consultants including regulatory review of promotional materials by specific country RA affiliate/consultant

• Contribute to improvements in department operating procedures

• Remain current with evolving regulatory procedures and practices, and provide guidance to company project teams

• Contribute positively to a strong culture of business integrity and ethics

• Act within compliance and legal requirements as well as within company guidelines

REQUIREMENTS

• BS degree, preferably in a scientific discipline with a minimum of 8 years pharmaceutical / biotechnology experience and with a minimum of 5 years regulatory experience, preferably including one full submission or line extension through authorization

• Experience in interactions with regulatory agencies. Experience with clinical trial applications

• Expert project management and interpersonal skills is a requirement, as well as excellent written and verbal communication ability

• Familiarity working with electronic document management and submission platforms is desired

• Experience in oncology and orphan products

LOCATION

Switzerland

DURATION

Permanent

SALARY

Competitive benefits package

ABOUT PLANET PHARMA

Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.

Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.

www.planet-pharma.com

TO APPLY

If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone on +44 (0)203 868 8607 or e-mail on schapple@planet-pharma.co.uk

If this role isn’t suitable for you, please let us know if you can refer anyone – any recommendations are much appreciated! Planet Pharma offers a competitive referral scheme so you will be rewarded for your help!

Company

Planet Pharma was founded by a dedicated team of professionals with extensive experience supporting the pharmaceutical, biotechnology, and device industries.

Our goal is to create an organization that strengthens the employer-employee dynamic by connecting clients with talent. This results in making staffing more personal and creating enduring, valuable relationships. We value communication with our clients and make it our priority to have the hiring process be as fast and successful as possible.

We leverage cutting-edge technology and flexible service delivery models that provide efficient, personalized solutions for your business.

Our global headquarters is in Northbrook, IL and branch offices are based across the United States and Europe.

Company info
Website
Telephone
+44 203 868 1000
Location
10 Greycoat Place
London
England
SW1P 1SB
United Kingdom

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