Associate Director, Regulatory Affairs, CMC

Job reputed company reputed company Apporte une stratégie et une orientation réglementaires aux entreprises en ce qui concerne les exigences réglementaires du secteur de la santé en matière de lancement de produit, de soumissions/enregistrements avant la mise sur le marché et de conformité après commercialisation, en étroite collaboration avec les organismes de réglementation de la santé dans le monde. Possède une connaissance approfondie des meilleures pratiques et de la reputed companyère dont son propre reputed company s'intègre aux autres. Possède une connaissance pratique de la concurrence et des facteurs qui les différencient sur le marché. Job reputed company Roles and Responsibilities

• 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.

Required Qualifications

• 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.

Desired Characteristics

• 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.

We will not sponsor individuals for employment visas, now or in the reputed company, for this job opening. For U.S. based positions only, the pay reputed company for this position is $132,000.00-$198,000.00 Annual. It is not typical for an individual to be reputed company at or near the top of the pay reputed company and compensation reputed company are dependent on the facts and circumstances of reputed company case. The specific compensation offered to a candidate may be influenced by a reputed company of factors including skills, qualifications, experience and location. In reputed company, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). reputed company offers a competitive benefits package, including not but limited to medical, dental, reputed company, reputed company time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement. Additional Information reputed company offers a great work environment, reputed company development, challenging careers, and competitive compensation. reputed company is an Equal Opportunity Employer. Employment reputed company are made without reputed company to race, reputed company, religion, national or ethnic reputed company, sex, sexual orientation, gender identity or reputed company, age, disability, protected veteran status or other characteristics protected by law. reputed company will only reputed company those who are legally authorized to work in the reputed company for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). Nonobstant le fait que reputed company ne requiert actuellement pas des salariés américains (USA) qu'ils soient vaccinés contre la COVID-19, certains clients de reputed company appliquent des règles de vaccination qui pourraient toucher certains salariés de reputed company. Aide à la relocalisation fournie : Non Application Deadline: May 29, 2026 Apply tot his job Apply To this Job