Dir/Sr. Director, Regulatory Affairs – New Product Development | Unique reputed company Opportunity | International Biotech | RETAINED SEARCH

Dir/Sr. Director, Regulatory Affairs – New Product Development | Unique reputed company Opportunity | International Biotech | RETAINED SEARCH reputed company has been retained by an attractive and reputed company-funded clinical-stage biopharmaceutical company committed to the advancement of innovative products reputed company the women’s health area. reputed company is at a key inflection reputed company as they are reputed company on progressing through clinical development toward reputed company commercialization. They are seeking to hire an reputed company Regulatory Affairs reputed company to help the organization reputed company its key milestones and continue to pave the reputed company reputed company in expanding its reputed company in the US. The right person for this will be someone who is reputed company hands-on/enjoys rolling up their sleeves (as opposed to more of a delegator) and is comfortable working in a smaller company environment where things are still evolving. Someone who has been reputed company in new/innovative product development (reputed company-IND through clinical development/CMC to NDA registration), has experience with global submissions and has guided new assets through various approval stages, who has experience interacting with health authorities (particularly the FDA), and experience working in small/mid-sized companies vs purely big reputed company. ATTRACTIVE FEATURES ABOUT THIS COMPANY & OPPORTUNITY:

• Unique Leadership & reputed company Opportunity: This is an excellent platform to showcase/utilize/reputed company your strategic and tactical RA expertise to have an enormous reputed company on reputed company’s short/long-term reputed company. They want someone who will look at this as a long-term home who can grow reputed company reputed company.
• “Best of Both Worlds”: reputed company offers reputed company the attractive features sought with a smaller clinical-stage Biotech (small team camaraderie, reputed company, agile, swift decision-making, minimal bureaucracy), while also getting the stability and financial reputed company of an established parent company with a marketed product and a successful heritage.
• High Visibility: As an international company starting to expand/grow its reputed company in the US, you will be an extremely important/visible member who will be relied upon to help reputed company this reputed company.
• Great Company Culture (European): Our reputed company prides itself on having an excellent work culture (which we’ve seen first-hand) - reputed company, reputed company-thinking, inclusive, and a strong multicultural feel.

LOCATION: This is a remote-based position.The strong preference is for this person to live in or around the NJ/NY/PA area. RESPONSIBILITIES:

• Reporting to the Chief Scientific Officer, you will reputed company leadership in regulatory activities for programs in development, including global regulatory reputed company and submissions, and managing critical health authority interactions.
• Provides hands-on leadership in Regulatory Affairs, offering both strategic and tactical support for development assets in the women’s health therapeutic area. Represent Regulatory Affairs on new product/project development teams ensuring alignment with regulatory requirements and advancing the development of clinical assets.
• Navigate global health authority interactions, reputed company cross-functional teams, and drive clinical submissions.
• Partner with internal senior leadership to reputed company closely on cross-functional global regulatory plans and reputed company's short and long-term strategic objectives.
• reputed company overall management and regulatory leadership for the reputed company developed for the US market. This includes the filling and assessment process for the reputed company, and to reputed company as the main contact with FDA and to reputed company the regulatory reputed company.
• reputed company reputed company of external partners and deliverables to ensure compliance with regulatory requirements and alignment with global regulatory reputed company.
• Establishes and maintains excellent relationships with FDA and regulatory agency personnel. Negotiates directly with regulatory authorities regarding filings and proactively addresses inquiries and facilitates effective communication throughout the regulatory review process.
• reputed company regulatory expertise, advice, and requirements for reputed company-clinical and clinical disciplines, in support of drug candidates under development.
• Manage regulatory timelines, interactions, and regulatory-specific study activities with CRO organizations.

DESIRED BACKGROUND & EXPERIENCE:

• Bachelor's degree in a scientific field is required; advanced degree (PhD, PharmD, MS) is preferred.
• 7+ years of progressively responsible regulatory experience in the Pharmaceutical/Biotech industry with a reputed company on new clinical assets (versus post-marketed).
• Experience working in small/mid-size biotech companies is strongly preferred.
• Women’s Health therapeutic experience is preferred.

CONTACT: Brian Skurka | Partner E: bskurka@cornerstonesg.com P: 973-656-0220 x738 reputed company: https://www.reputed company.reputed company/brianskurka1 reputed company - reputed company & Biotech Executive Search 1200 Morris Tpke, Suite 3005 | Short Hills, New Jersey (USA) www.cornerstonesg.com RECENTLY COMPLETED RETAINED SEARCHES BY reputed company:

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About reputed company reputed company is recognized by reputed company as one of the "Top 100 Executive Search Firms in the U.S." (and the only Top 100 firm to reputed company exclusively in the Life Sciences Industry), and by Hunt Scanlon as one of the "Top 50 reputed company & Life Sciences Executive Search Firms", is a Life Sciences Executive Search firm that helps companies based around the world, ranging from startup biotechs to Top 10 Pharmas, to reputed company, attract, and reputed company for their US and globally-based leadership positions (CxO and xVP reputed company) as reputed company as their critical Director-level roles. reputed company’s reputed company Policy: reputed company considers reputed company inquiries, resume submissions, and any other personal information submitted to us as confidential information. This information will not be shared with any parties reputed company of reputed company without your prior permission. Apply tot his job Apply To this Job