Head of Regulatory, Quality & Safety Affairs - Eastern Europe
- Contract Type
Company: Small / Mid-Sized Growing Pharmaceutical Company
Position: Head of Regulatory, Quality & Safety Affairs - CZ/SK (The role sits on the membership board)
Location: Czech Republic
Reports to: Global Head of RA
An exciting opportunity to join a dynamic, game-changing team within a rapidly growing healthcare company with a diverse portfolio. The role scope is to be the functional country head of the regulatory, quality and safety operations in Czech and Slovak Republic. The role will attract a high level of autonomy and responsibility for management of workload and priorities. This person will lead the regulatory, quality, safety team in CZ and SK, aiming to be best in class in the industry, and will be visible to senior levels of the local and international business.
- Enabling Commercial Strategy: Ensure development of local regulatory strategy for new product registration & licence maintenance, fully aligned to business needs. Actively contribute to and define claims-support rationale, to obtain the strongest commercial platform possible.
- Ensuring compliance: with all legal obligations in the area of drugs, medical devices, food supplements, cosmetics and biocides. Ensuring vigilance for the local product portfolio of the company for all types of products (pharmacovigilance, medvigilance , materiovigilance etc) and full compliance with QA requirements. Including oversight, identification, training and monitoring of process improvements and ongoing-compliance.
- Oversees and ensure establishment and maintenance of quality: - CE certification, ISO 9001, ISO 13485. Ensuring compliance with GDP and supervise all relevant local quality operations and systems including local batch release and audits etc. Supervise the quality of contract manufacturing.
- Internal Stakeholder Management: Effectively manage expectations across a broad range of business stakeholders, employing high quality communications in all interactions.
- External Relations: Continue to build strong relationships with Regulatory Authorities, Trade Associations & Key Opinion Leaders, forming a go-to network for strategy development and problem solving. Ensure communication with state health authorities in the area of all product types in the local portfolio.
Education & experience required:
- Educated to degree level within life sciences. Pharmacist degree is beneficial
- Substantial experience (4+ years) working within regulatory affairs, ideally within OTC
- Experience includes Medicines and Medical devices; with Medicines experience spanning new MAAs (with awareness of National Procedures/DCP/MRP), as well as management of line extensions and licence maintenance activities.
- Experience with Traditional Herbal Medicinal Products, Biocides, Food Supplements, Veterinary Products and Cosmetics would also be beneficial.
- Strong experience (2+ years) within Quality affairs for medicines and medical devices and cosmetics. Good understanding and experience with GMP & GDP and ISO requirements.
- Extensive involvement in the generation/review of product claims and advertising materials across product types.
- Experience with Pharmacovigilance and materiovigilance systems
- Fluent English
Values & Competencies sought:
Show Passion and Energy
- Able to work independently and self-start to define a path and gather knowledge
- ‘Can do’ mentality, diving in from day 1 to get the job done
- Ability to prioritise in line with business needs, managing stakeholders & expectations.
Go the Extra Mile
- Always looks for opportunities to do more
- Takes initiative and takes risk when justified
- Displays thoroughness in analysis and follow-up.
Change the Game
- Generates creative solutions to problems faced
- Able to make decisions in ambiguous situations
- A ‘sales enabling’ regulatory mindset.
Be Curious and Savvy
- Curious about the OTC and non-medicine healthcare landscape and potential opportunities for Omega
- Savvy enough to understand the commercial priorities and identify opportunities that complement, building regulatory strategy which aligns to business need
- Ability to critique data, assess probability of success and adapt based on strength of position
- Impactful negotiator, able to adapt style to audience (Regulatory Authorities, notified bodies, policy makers etc).
Be Open and Gracious
- Demonstrates empathy & respect for people
- Fosters collaboration with other functions & departments, at all levels, and acts as an equal partner and valued voice in all interactions
For more information, please do reach out to me directly!
+44 1293 77 66 44
Barrington James is a uniquely successful specialist life science recruitment company and has recently been recognised as a BEST COMPANY To Work For by the Sunday Times. It has enjoyed an exceptional growth trajectory since its launch in 2002, and is now established in the heartlands of the international pharma, medical devices and healthcare industry with consultant staff already approaching 140, and planned to be 180 by the end of 2017.
Recruitment companies succeed by matching the specific needs of clients with the true capabilities of candidates. We believe there are 2 reasons for our outstanding performance over the past decade, which benefit our clients and our candidates equally; People & Knowledge Barrington James’ exceptional people and their depth of experience are ready to work for you, now.