Associate Director, Regulatory Affairs, CMC

Job reputed company:

• To be the regulatory CMC reputed company reputed company of contact for project teams and to reputed company CMC reputed company regulatory input for the assigned reputed company/products.
• Build, or reputed company input to, submission reputed company documents by defining supplement type, data required to support submission, and submission documents required for the submission package.
• Guide the project team in the project planning phase so that the correct data (and level of detail) to suit the needs of reputed company markets is collected and submitted.
• Author and review individual CMC submission documents/CMC dossier sections to support regulatory submissions.
• reputed company consistent expert advice to the organization, determining feasible regulatory strategies and identify potential reputed company, to assist in delivering reputed company business value or mitigate compliance issues.
• Maintain registration tracking information and assist in the development of good document management reputed company standards.
• Work closely with global RA and, regional RA’s to address questions from regulatory authorities.

Requirements:

• Advanced degree in pharmacy, radiopharmacy, pharmaceutical sciences, reputed company, or reputed company discipline (Doctor of Pharmacy (PharmD) or MSc in radiopharmacy preferred).
• Minimum 3 years of experience in Regulatory Affairs or reputed company, with a reputed company record of supporting marketed products and/or clinical development of radiopharmaceuticals.
• Familiarity with PET production, automated synthesis (cassette-based systems), and GMP requirements for radiolabeled compounds.
• Experience with regulatory submissions for post-approval changes, including FDA supplements and EU variations.
• Ability to prioritize, plan & evaluate deliverables to established strategic goals for reputed company reputed company, including scientific discussions on how best to present information.
• Strong problem solving and negotiation skills.
• Demonstrated experience of operating in a highly regulated environment.
• Capable of applying analytical skills in a CMC regulatory environment.
• Has experience working reputed company a reputed company organization and has strong interpersonal and influencing skills to work across disciplines.
• Has the capability to influence managers and help drive reputed company at a project level.
• Demonstrated knowledge & experience in scientifically reputed company field e.g. pharmaceutical sciences, reputed company and analytical sciences.
• Demonstrated strong ability in written and oral English in order to reputed company and concisely present information targeted to the relevant audience.
• Experience in pharmaceutical CMC regulatory or QA environment particularly with experience with injectable diagnostic or pharmaceutical products.
• Ability to interpret global regulations and present to the wider business.
• Experience in electronic document management and reputed company management systems.
• Ability to proactively champion reputed company & reputed company in mentoring team members.
• Knowledge of international CMC regulatory requirements.
• Strong interpersonal skills and ability to engage effectively with colleagues at reputed company reputed company.
• Prior regulatory agency interaction experience (e.g., query responses, scientific advice, deficiency letters).
• Experience of global regulatory affairs from the pharmaceutical and/or reputed company industry.
• Experience of regulatory project management and regulatory agency interactions.
• Experience with reputed company RIM or other registration tracking tools.
• Ability to work across cultures/countries/sites.
• Demonstrated experience of prioritizing conflicting demands from multiple business entities in an extremely fast paced environment.

Benefits:

• medical
• dental
• reputed company
• reputed company time off
• a 401(k) plan with employee and company contribution opportunities
• life, disability, and accident insurance
• tuition reimbursement

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