What are the responsibilities and job description for the Senior Dir / VP Regulatory Affairs position at Context Therapeutics?

Position

Senior Director / VP, Regulatory Affairs

This position is responsible for building the regulatory team at Context Therapeutics. The Director / VP of Regulatory Affairs will define and implement innovative regulatory strategies that expedite the development and approval of our portfolio of investigational products. You will act as the regulatory lead on relevant project teams to define and execute development strategies for these programs. You will be the primary contact for interfacing with the FDA and will lead cross-functional teams to deliver both domestic and international regulatory submissions, including IND, CTA, NDA, and MAA submissions. You will hire, coach, and mentor junior regulatory staff to support their development and facilitate program deliverables.

Company

Context Therapeutics Inc.

Responsibilities

Serve as the company’s in-house expert on all regulatory matters - US and global.
Lead and manage the development and implementation of US / global regulatory plans and identify risk mitigation strategies to maximize the likelihood of regulatory success.
Lead cross-functional teams to prepare high-quality regulatory submissions to ensure clarity, consistency, and completeness, satisfying the regulatory framework while aligning with the Company’s strategic objectives.
Work in collaboration with project teams to provide strategic regulatory guidance for initiation and maintenance of clinical studies; act as primary regulatory representative on project teams and with relevant CROs to ensure that development activities support and comply with relevant regulatory requirements.
Direct the strategy and preparation of documents in eCTD format for submission to the US FDA, EMA and other regulatory agencies to support timely approvals and competitive labelling. Own the preparation of these major clinical submissions.
Act as lead communicator with all regulatory agencies.
Anticipate regulatory obstacles and emerging issues throughout the pharmaceutical product development lifecycle and develop solutions with other members of development teams.
Develop and maintain excellent relationships with key FDA / EMA personnel, including auditors, coordinators and reviewers; attend all conference calls and meetings.
Manage responses to regulatory authority queries and critically review submissions for appropriate scientific rationale and strategic impact.
Develop and implement internal regulatory processes and procedures, including SOPs, to ensure global regulatory compliance with all cGxPs and other regulatory agency requirements.
Manage follow-up program(s) to address audit findings and monitor ongoing CMO, CRO and vendor / supplier compliance.
Ensure close collaboration among all internal groups. Work closely with senior management, staff, consultants, investigators, outside vendors, etc.
Partner with and support clinical development, CMC, medical affairs, commercial and corporate activities, including the critical review and submission of clinical protocols and regulatory documents, publications, investor relations / legal public disclosures throughout the product life cycle.
Keep peers and superiors apprised of expected changes to the regulatory landscape affecting existing and future company programs.

Requirements

A minimum of 10-years global regulatory affairs experience in a pharmaceutical / biotech company. BS / BA in the life sciences; advanced degree in science preferred. Regulatory Affairs Certification (RAC) also preferred.

Demonstrated ability as a regulatory strategist coupled with a solid track record of successful interactions with the FDA Office of Oncologic Diseases, as well as ex-US health ministries. Such interactions should include successful End of Phase 2 meetings.

Experience in oncology and women’s healthcare is highly preferred.

In-depth understanding of regulatory processes, procedures, guidelines, US / Global regulatory strategy, and the ability to integrate into company-wide goals.

Experience in the preparation and submission of US and global filings including INDs, CTAs, NDAs, MAAs, and BLAs in eCTD is essential.

Comprehensive and disciplined approach to risk management and regulatory compliance through an intimate understanding of processes and systems, a network of appropriate contacts, and an in-depth knowledge of the internal operations and culture of the FDA and related agencies.

Ability to interpret and apply FDA and international guidelines and regulations; and anticipate regulatory concerns.

A background overseeing quality assurance is a plus.

Travel as needed.

Benefits

401(k)

Dental insurance

Health insurance

Vision insurance

Work Location

Greater Philadelphia, PA area. Remote candidates will be considered.

Hybrid work model, which allows for work to be completed from home and in the office.

Onsite presence expected two to three days per week.

About Context Therapeutics

Context Therapeutics Inc. (Nasdaq : CNTX) is a biopharmaceutical company advancing T cell engaging (“TCE”) bispecific antibodies for solid tumors. Context is building an innovative portfolio of TCE bispecific therapeutics, including CTIM-76, a Claudin 6 x CD3 bispecific antibody, CT-95, a Mesothelin x CD3 bispecific antibody, and CT-202, a Nectin-4 x CD3 bispecific antibody. Context is headquartered in Philadelphia..

Context Therapeutics is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity / expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

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