Regulatory Affairs Manager - Biotech

PURPOSE

The role carries a broad range of responsibilities and the specific areas of focus will be dependent on the skills and experience of the person holding the role and will offer the chance to diversify experience.

The main responsibility is to establish and ensure the company has a comprehensive and efficient global regulatory strategy that aligns pharmaceutical product development timelines, product authorisations and budget.

Additionally, the Regulatory Manager will be responsible for rolling out and coordinating the activities related with regulatory approvals, both internally and with applicable regulatory authorities.

The Regulatory Manager will help increase the awareness of relevant regulatory standards and guidance’s throughout the organisation.

MAIN RESPONSIBILITIES

• Maintain good contacts with global competent authorities
• Write and maintain IMPD for all products
• Coordinate writing and approval of regulatory required documentation
• Coordinate regulatory submissions
• Review and approval of the rationale and regulatory impact assessment related to any potential (substantial) changes to the product, manufacturing process, analytical methods of our products under the Pharmaceutical Quality System
• Functioning as a regulatory point of contact for the company’s external partners, or Health Authorities for regulatory questions
• Informing senior management on any potential (upcoming) ATMP regulatory or guidance document changes which may impact their products development and authorisations
• Overall responsible for product approval timelines coordination

EDUCATION & KEY REQUIREMENTS

The job as Regulatory Manager will be held by a person with:

5 - 10 years of regulatory experience within ATMP or industrial (bio)pharmaceuticals

Ability to implement complex regulatory details in a simple strategy while adhering to relevant regulations

LOCATION

South-East Netherlands – flex to work from home

DURATION

Full-time, permanent

SALARY

Attractive package with competitive benefits

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!