Regulatory Affairs Lead

Job title:

Regulatory Affairs Lead

Firm

Spark Therapeutics

Job description

Be a part of the Spark WorkforceWe have been born of innovation, springing from the curiosity, creativeness and dedication of outstanding scientists and healthcare visionaries. Our shared mission is to unlock the ability of gene remedy to speed up healthcare transformation.We don’t comply with footsteps. We create the trail.Major DutiesThe Director, Regulatory Affairs will interface with the European Medicines Company (EMA) in addition to EU and Worldwide competent authorities for his or her assigned program(s) as wanted to help our Spark portfolio. In time, s/he can also acquire the chance to tackle the International Regulatory Lead function for a program. The Director, Regulatory Affairs will direct and/or lead the preparation of submissions, which can embrace Briefing Paperwork for Company conferences, scientific trial purposes, Orphan Drug Designation purposes, Pediatric Investigational Plans and Advertising and marketing Authorisation Purposes. S/he’ll contribute to shaping scientific growth packages to satisfy the wants of EU and different ex-US regulatory stakeholders and develop & implement the EU/Worldwide regulatory technique.The Director, Regulatory Affairs will collaborate with different Regulatory Affairs & Affected person Security leaders as essential to help the construct of acceptable EU/Worldwide infrastructure related for growing regulatory coverage and intelligence actions within the EU/Worldwide area.The precise candidate for this function will probably be a self-starter with sturdy expertise of scientific growth and regulatory filings for biologics and gene remedy merchandise. The power to work each independently in addition to collaboratively throughout cross-functional groups and lead direct interactions with EU/RoW regulatory businesses is crucial.Along with main the compilation of supplies required in submissions, license renewals and annual registrations, the Director, Regulatory Affairs will suggest adjustments for labeling, manufacturing, advertising and marketing and scientific protocol for regulatory compliance and maintain abreast of regulatory procedures and adjustments. S/He’ll suggest methods for earliest attainable approvals of scientific trial and advertising and marketing authorization purposes and mix information of scientific, regulatory, and enterprise points to allow merchandise which can be developed, manufactured and/or distributed to satisfy required laws in EU and ex-US/EU markets.Obligations

• Lead the event of EU/Worldwide regulatory methods within the given area and benefit from region-specific regulatory methods and processes, specifically the applying of modern regulatory pathways, to expedite the event of Spark packages.
• Lead interactions with regulatory businesses within the given area at each nationwide and central stage and lead inner groups in navigating such interactions.
• Function a useful resource for EU/Worldwide information for the worldwide scientific growth group.
• Monitor rising laws and steerage within the given area and contribute to making sure company-level consciousness and compliance (the place acceptable).
• Present help to particular program groups to deal with a variety of difficulty together with submission of scientific trial/GMO/CDx purposes, growing responses to utility requests for info and provision of CRO oversight as required.

• Function Spark regulatory consultant for the assigned program(s).
• Lead the regulatory submissions (ODDs, PIPs, CTAs and so on.) related to assigned packages, in accordance with submission and approval necessities. Lead practical teams throughout the group within the growth of related information to finish regulatory submissions.
• Lead preparation of submission-relevant paperwork referring to firm’s growth actions: new recordsdata, label extensions, scientific trial purposes.
• Put together and keep product authorization purposes, e.g., MAAs.
• Present regulatory enter to market entry technique and HTA plans and submissions within the EU/Worldwide area.
• Guarantee QP necessities and native regulatory necessities are fulfilled for every nation as obligatory.
• Monitor purposes below regulatory evaluation; talk utility progress.
• Reply to objections/questions issued by Regulatory Authorities/Companies.
• Lead Spark response to objections/questions issued by EU/Worldwide Regulatory Authorities/Companies.
• Lead the preparation, submission and follow-up of Orphan Drug Purposes, Pediatric Research Plans, Pediatric Investigational Plans, and so on.
• Report hostile occasions and different unanticipated issues to EU regulatory businesses and inner stakeholders.
• Answerable for accuracy and content material of communications
• Lead the preparation, evaluation, and approval of compliant regulatory paperwork all through the product lifecycle.
• Present EU regulatory steerage to cross-functional groups for venture and product lifecycle planning.
• Anticipate regulatory obstacles and rising points, together with altering rules, all through the product lifecycle and develop options with different members of regulatory and cross-functional groups.
• Work successfully with regulatory colleagues specializing in different practical areas to repeatedly enhance regulatory methods, teamwork, and effectivity.
• Consider proposed nonclinical, scientific, and manufacturing adjustments for regulatory submitting methods.
• Handle and execute pre-approval and post-marketing compliance actions.

• Lead the event & implementation of EU regulatory insurance policies, processes, methods, and SOPs and prepare key personnel on them.
• Contribute to the event of related networks with Roche colleagues to help the continued construct of regulatory coverage and intelligence actions/interactions for the EU/Worldwide area.
• Assist and contribute to the event of Spark international regulatory methods to advance Spark merchandise by the regulatory evaluation and approval course of globally.

• Actively contribute to the event and implementation of regulatory processes for multi-country trials.
• Different program-related duties and duties as could also be required.

Training and Expertise Necessities

• Diploma in life science, e.g., Pharmacy, Biology or Chemistry required. PhD or different superior scientific levels strongly most well-liked.
• Typically, has 10+ years associated expertise (e.g., healthcare, and/or scientific analysis expertise), with no less than 8 years of direct regulatory expertise.
• Expertise with regulatory submissions and approvals and a confirmed observe report of supporting regulatory purposes (CTAs, MAA, PIP, scientific recommendation and so on.) is obligatory.
• Expertise of straight working with the EMA and nationwide regulatory businesses and main company conferences head to head.
• Expertise of bringing a product by EU approval is a definite benefit.
• Expertise working with novel drug therapies and orphan product is most well-liked.
• Present information and understanding of GxPs (GCPs, GLPs, GMPs) and ICH pointers in addition to EMA, FDA, worldwide, and, if relevant, native rules.

Key Expertise, Talents, and Competencies

• Potential to barter and concisely specific clear positions to stakeholders in any respect ranges.
• Wonderful written and verbal communication expertise.
• Thorough information of the drug growth course of, with a give attention to CTA and MAA/NDA/BLA processes.
• Wonderful writing expertise with a capability to write down detailed info for submissions.
• Wonderful means to learn, analyze and interpret technical paperwork, technical procedures and authorities rules.
• Put together and ship efficient displays for exterior and inner audiences.
• Information of computer systems and acceptable software program packages. Expertise with digital submissions most well-liked.
• Potential to deal with a number of duties and powerful consideration to element.
• Wonderful interpersonal communication and organizational expertise.
• Profitable efficiency in a high-intensity work setting.
• Information of regulatory historical past, pointers, insurance policies, requirements, practices, necessities and precedents.
• Present information and understanding of moral pointers of scientific analysis and the regulatory course of.

Spark Therapeutics doesn’t settle for unsolicited resumes/candidate profiles from any supply apart from straight from candidates. Any unsolicited resume/candidate profile submitted by our web site or to private e mail accounts of staff of Spark Therapeutics are thought-about property of Spark Therapeutics and should not topic to cost of company charges.

Anticipated wage

Location

London

Job date

Sat, 06 Apr 2024 22:21:46 GMT

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