Senior Manager, Regulatory Affairs
- Waltham, MA, USA
Kala Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of therapeutics using our proprietary AMPPLIFY™ Drug Delivery Technology, with an initial focus on advancing treatments in ocular diseases. Kala’s first approved product is INVELTYS™, the first and only corticosteroid FDA-approved for BID treatment of post-operative inflammation and pain following ocular surgery. Kala’s lead pipeline product is KPI-121 0.25%, for the temporary relief of the signs and symptoms of dry eye disease, currently in Phase 3 clinical development. Kala anticipates filing for NDA with its current data set in the second half of 2018.
Kala is an emerging pharmaceutical company on the verge of commercialization. We are seeking a Senior Manager, Regulatory Affairs. This is an opportunity for the right individual to get hands on experience with NDA filings and building global regulatory strategies. This position will support US regulatory submissions as well as support the company’s overall global regulatory strategy. The position will partner closely with the clinical development team and external consultants to advance the company’s portfolio and ensure commercial success. The successful candidate will help guide the strategic direction of the development programs and assure they are designed to meet regulatory approval standards on a global basis.
Key Responsibilities for this role will include:
- Provide leadership in creating and executing proactive global regulatory strategies for product development, approval and registration, and support of future marketed products.
- Lead the process for filing regulatory submissions.
- Proactively build relationships and trust with key internal and external stakeholders and decision makers.
- Develop and implement regulatory strategies, including regulatory risk management, ensuring that any RA issues are highlighted and addressed satisfactorily and in a timely fashion. Create key development documents.
- Oversee post-approval commitments and monitoring and reporting of key priorities and obligations. Participate in the review of labeling and promotional material to ensure compliance with regulation.
- Support business development and due diligence efforts.
- Remain on the forefront of the relevant science and competitive landscape including detailed competitive intelligence, and be an expert in its application to the regulatory process.
Specific professional experience and qualifications include:
- Successful steering of critical (IND, NDA, MAA) filings and life cycle management.
- Proactive, creative, forward-thinker with the ability to think innovatively about integrated global strategy for regulatory.
- Experience working with R&D and commercial leadership teams.
- Experience in dealing with FDA, EMA and other agency liaison activities.
- Broad knowledge of the regulatory and competitive environment across key regions, and anticipation of future trends and impact.
- Strong understanding of the drug development process.
- Excellent organizational and project management skills and ability to think strategically.
- Outstanding presentation, written and oral communication skills required. A clear communicator who can influence effectively both internally and externally.
- B.A./B.S. in the sciences, or health related field.
- 5 years regulatory experience. Advanced degree preferred.
- Successful track record interacting with the regulatory agencies, as demonstrated by timely submissions and approvals of specialty pharmaceutical/biotech compounds.
All your information will be kept confidential according to EEO guidelines.