QbD Group offers
knowledge & tailored (software) solutions in development, clinical, regulatory & compliance, production and distribution
for companies active in Pharma, Biotech and Medical Devices/IVD. Our Regulatory Affairs division supports customers throughout the
entire regulatory lifecycle
of their products, whether they are traditional pharmaceutical products, generic medicines, vaccines, biologicals, biosimilars, medical devices, IVDs or Advanced Therapy Medicinal Products (ATMP). Our RA division has a
strong international presence
with over 30 colleagues in Belgium, the Netherlands, the UK, Spain and Austria. Our customer portfolio spans the entire globe (Asia, US, Europe, Africa). We are looking for an
(Associate) Director Regulatory Affairs Pharma to join our UK team. What do we expect from you as (Associate) Director Regulatory Affairs Pharma ?
You provide a
full range of regulatory consulting services
(strategy and writing) with an emphasis on clinical documents (overviews, briefing packages, orphan drug designations, paediatric investigation plans). You deliver
complex projects
on time and to a high quality. You are a source of regulatory expertise in the development, registration and post-licensing activities of pharmaceutical products. You have
line management
responsibility and provide guidance to the international QbD team across projects (training, supervising, mentoring, reviewing). You interact professionally at multiple levels within a client organization. You continue to build a
network
of industry colleagues. You develop and maintain personal contacts with regulatory agencies or professional associations to build confidence in and enhance the reputation of QbD Group. You assist in the preparation of
proposals
(e.g. researching new potential projects, determining activities required). You are able to commute to our headquarters in
Chalgrove
(Oxford area) for onsite working 2 days per week. Who are we looking for?
You have a
university degree in life science . You have sound knowledge of European pharmaceutical regulations and guidelines. You have
significant regulatory affairs experience
including a successful track record in the development, registration and life-cycle maintenance of medicinal products within Europe, in particular a strong background in the review/generation of
clinical documents
(overviews, briefing packages, orphan drug designations, paediatric investigation plans). You have excellent
written and verbal communication skills and proven negotiation skills . You can establish strong connections with clients, regulators, management and colleagues. You have good organizational skills and an analytical mindset. You enjoy working in an
international environment . A
true QbD’er
can be recognized by the following qualities: Resilient : Your strong and positive attitude helps you overcome any challenge Hungry for knowledge:
You are always open to learning No non-sense mentality:
you can be straightforward in a respectful way Innovative : You are constantly looking for new and better solutions (Not too) serious : your job is serious, but you don’t take yourself too serious. What’s in it for you?
QbD Group offers you an
attractive and competitive salary package , that will be tailored to individual needs, considering legal requirements and local laws and regulations. Join us to build a
sustainable career , where job security is ensured, and lasting, meaningful connections are formed. As we’re a
knowledge-based company , you’re guaranteed to embark on a continuous journey of learning and development. Be part of our global success story. As an
award-winning company
we value everyone’s contribution and celebrate achievements together Our
promise
to you: As an
ambitious and pioneering company , we want to offer you the best possible environment to thrive within the life sciences. Moreover, we aim to create a
joyful community
where you dare to be and can be yourself. Because the best way to grow is by growing together as unique individuals. In short … We stand for?
JPEG :
J oy in
P artnership, going for the
E xtra mile to
G et things done! Interested?
Send us your CV and motivation letter and who knows, we might welcome you soon in our QbD family!
#J-18808-Ljbffr
knowledge & tailored (software) solutions in development, clinical, regulatory & compliance, production and distribution
for companies active in Pharma, Biotech and Medical Devices/IVD. Our Regulatory Affairs division supports customers throughout the
entire regulatory lifecycle
of their products, whether they are traditional pharmaceutical products, generic medicines, vaccines, biologicals, biosimilars, medical devices, IVDs or Advanced Therapy Medicinal Products (ATMP). Our RA division has a
strong international presence
with over 30 colleagues in Belgium, the Netherlands, the UK, Spain and Austria. Our customer portfolio spans the entire globe (Asia, US, Europe, Africa). We are looking for an
(Associate) Director Regulatory Affairs Pharma to join our UK team. What do we expect from you as (Associate) Director Regulatory Affairs Pharma ?
You provide a
full range of regulatory consulting services
(strategy and writing) with an emphasis on clinical documents (overviews, briefing packages, orphan drug designations, paediatric investigation plans). You deliver
complex projects
on time and to a high quality. You are a source of regulatory expertise in the development, registration and post-licensing activities of pharmaceutical products. You have
line management
responsibility and provide guidance to the international QbD team across projects (training, supervising, mentoring, reviewing). You interact professionally at multiple levels within a client organization. You continue to build a
network
of industry colleagues. You develop and maintain personal contacts with regulatory agencies or professional associations to build confidence in and enhance the reputation of QbD Group. You assist in the preparation of
proposals
(e.g. researching new potential projects, determining activities required). You are able to commute to our headquarters in
Chalgrove
(Oxford area) for onsite working 2 days per week. Who are we looking for?
You have a
university degree in life science . You have sound knowledge of European pharmaceutical regulations and guidelines. You have
significant regulatory affairs experience
including a successful track record in the development, registration and life-cycle maintenance of medicinal products within Europe, in particular a strong background in the review/generation of
clinical documents
(overviews, briefing packages, orphan drug designations, paediatric investigation plans). You have excellent
written and verbal communication skills and proven negotiation skills . You can establish strong connections with clients, regulators, management and colleagues. You have good organizational skills and an analytical mindset. You enjoy working in an
international environment . A
true QbD’er
can be recognized by the following qualities: Resilient : Your strong and positive attitude helps you overcome any challenge Hungry for knowledge:
You are always open to learning No non-sense mentality:
you can be straightforward in a respectful way Innovative : You are constantly looking for new and better solutions (Not too) serious : your job is serious, but you don’t take yourself too serious. What’s in it for you?
QbD Group offers you an
attractive and competitive salary package , that will be tailored to individual needs, considering legal requirements and local laws and regulations. Join us to build a
sustainable career , where job security is ensured, and lasting, meaningful connections are formed. As we’re a
knowledge-based company , you’re guaranteed to embark on a continuous journey of learning and development. Be part of our global success story. As an
award-winning company
we value everyone’s contribution and celebrate achievements together Our
promise
to you: As an
ambitious and pioneering company , we want to offer you the best possible environment to thrive within the life sciences. Moreover, we aim to create a
joyful community
where you dare to be and can be yourself. Because the best way to grow is by growing together as unique individuals. In short … We stand for?
JPEG :
J oy in
P artnership, going for the
E xtra mile to
G et things done! Interested?
Send us your CV and motivation letter and who knows, we might welcome you soon in our QbD family!
#J-18808-Ljbffr
