Reference Number: JO-2006-451450
Associate Director, Regulatory Affairs
Job Type: Permanent
Role: Associate Director, Regulatory Affairs
Location: flexible fully remote work available
Salary: competitive + benefits
employment: full time, permanent
Regulatory Professionals are collaborating with dynamic biopharmaceutical company that is mak-ing a real difference to our patients life who suffer from rare diseases. You will be responsible for providing strategic and operational direction for the planning, management, support and execu-tion of regulatory activities for our clients drug products (clinical and commercial) within Europe. This role includes responsibility for support of regional registration and life cycle management reg-ulatory activities.
Other duties will include:
In alignment with our clients global regulatory strategies, assist in the development and im-plementation of regional regulatory strategies for our clients compounds in all stages of clini-cal and commercial development.
Serves as a liaison to regional regulatory Health Authorities including the European Medicines Agency (EMA) and other national authorities
Actively maintains knowledge of French regulatory requirements (e.g. new regulations, laws, etc.) and shares key insights with the business and global team.
Supports strategies for, coordinates the execution of, and ensures the proper archival of reg-ulatory submissions including, but not limited to: Clinical Trial Applications (CTAs); Marketing Authorization Approvals (MAAs) including those required to maintain approvals (i.e. varia-tions, renewals) and customized dossiers for the registration of drug products in countries within the region.
Provides regulatory support for country specific Early Access Programs (EAPs). This may also include the preparation of supportive regulatory documents for these programs.
Collaborates with project teams and other internal and external key stakeholders as appro-priate to ensure effective local product registrations.
Ensures that drug products distributed with the region meet local regulatory requirements while also supporting our clients commercial/business objectives.
Provides regulatory support to the Global Pharmacovigilance (PV) organization as necessary to ensure that our clients PV obligations are met.
Bachelors degree in a relevant discipline and a minimum of 7 years of progressively responsi-ble Regulatory Affairs experience in a pharmaceutical, biotechnology, contract research organi-zation (CRO) or related environment with at least 2 years of successful experience in a regional Regulatory Affairs role.
Prior experience helping to build a regional Regulatory Affairs function for a growing organiza-tion.
In-depth knowledge of relevant, regional regulatory guidelines and requirements.
Demonstrated, hands-on experience managing and preparing all phases of regional/country-specific regulatory submissions including knowledge of National, Mutual Recognition and De-centralized/Centralized procedures.
Demonstrated track record of success building relationships with, and influencing, regional and/or national health authorities, particularly in situations requiring direct interac-tion/negotiation.
Demonstrated success gaining regional regulatory approval and in providing regulatory sup-port for post-marketing and life cycle management activities such as variations, renewals and labelling.
Experienced providing regulatory support for CTAs and Chemistry, Manufacturing and Control (CMC) related activities
Prior experience managing projects is preferred.
Outstanding written and verbal communication skills.
If you would like to apply for this position, please contact Amani via email@example.com. If you are not currently looking but know someone who would be good for this role then get in touch. We offer a referral scheme at Regulatory Professionals where in which a successful recommendation will earn you 250 worth of vouchers *terms and conditions apply*