Associate Principal Scientist, Global Regulatory Lead

Job Description

The Position

Associate Principal Scientist, Global Regulatory Lead reporting to the Executive Director, Fertility Lead will be responsible for the development and implementation of world-wide regulatory strategies, including CMC elements, for the medical devices and combination products (MDCP) portfolio.

Primary Responsibilities

Develop regulatory strategy for medical devices and combination products (MDCPs), to optimize labeling claims and obtain shortest time to approval by regulatory agencies, including but not limited to US-FDA, EU/Notified Bodies, and other agencies worldwide

Independently manage projects; functioning as the single, accountable, global point of contact for global regulatory strategy development including CMC related considerations

Executes regulatory strategies by leading the development, authoring and review of MDCP CMC submission components to support post-approval supplements, annual reports, registration renewals, and responses to health authority questions per established business processes and systems

Lead the Global Regulatory Teams, which coordinates cross-functional regulatory support for development programs and marketed products

Independently interact with worldwide regulatory agencies and/or subsidiaries regarding global regulatory strategy/registration requirements for one or more of investigational and/or marketed devices/combination products.

Cover programs that may be complex with more than one indication, formulation, or have an external business partner.

Coordinate the preparation, submission, and follow-up contact with regulatory agencies and/or subsidiaries for all applications and submissions.

Conduct Regulatory review and final approval of all submissions and associated documentation; perform risk assessments and communicate strategic decisions taken to obtain stakeholder alignment.

Provide expertise as the Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and outside.

Communicate new legislations, guidelines and standards which may affect company’s product to other Teams, to ensure that any broader impact to the organization is fully understood and assessed.

Support regulatory activities of medical devices including standalone and combination with medicinal products.

Review and provide the final approval of local registration study protocols when needed to obtain marketing authorization in secondary markets.

Represent our company with external organizations through direct communication with the FDA, EMA, or other EU regulatory agencies, including telephone calls and e-mail; chair meetings between company and FDA or EMA; prepare our company's teams for meetings with FDA or EMA at any phase of drug development. Lead cross-functional efforts to prepare and lead discussion at scientific advice and advisory committee meetings.

Coordinate interactions with foreign agencies working closely with regional colleagues to support their interactions and provide strategic direction across multiple regions simultaneously.

Review and provide final approval Worldwide Marketing Applications, Clinical Study Reports, protocols, Confidential Investigator Brochures before release from our company to external agencies and investigators.

Provide expert advice to Product Development Teams and subsidiaries on regulatory issues as they arise with the developmental compounds or marketed products throughout the entire life cycle of the drug.

Represent Global Regulatory Affairs within our company's internal committees to provide regulatory advice and approval according to the committee charters.

Participate in regulatory due diligence activities for licensing candidate review as needed

Participate in projects outside of current responsibilities as needed to drive the organization forward to success.

Contribute to determining solutions outside of current responsibilities as needed and manage day-to-day operational issues outside of current responsibilities, as needed.

Provide education, training, and advise company professionals to ensure compliance with internal and external processes, procedures, policies, and regulatory requirements.

Requirements For Education, Experience & Skills

Ph.D., Pharm. D., or M.D. with 3 years relevant drug development experience required preferably with 3 years in Regulatory OR

M.S. or B.S. with 5 years relevant device or drug development experience, a majority of which should be in Regulatory

Fluency in English (written and spoken)

Develops and manages world-wide regulatory strategies of assets that tend to be at a medium activity and complexity level, as well as post-approval products with limited clinical development

Regulatory product and compliance management (coordinates the preparation, submission and maintenance of asset applications)

Has good verbal and written communications skills (manages communications with health agencies)

Has knowledge of regulatory regulations and guidance from key health agencies.

Has an intermediate level understanding of his/her therapeutic area.

Has superior interpersonal skills to navigate difficult situations and able to  work seamlessly with all levels of personnel from R&D, commercial and manufacturing organizations.

Has proven track record to be able to think critically, strategically, independently and problem solve.

Has a high level of motivation, drive, and demonstration of Organon leadership values.

Demonstrated scientific knowledge, writing ability, effective communication, and thorough familiarity with worldwide regulatory agencies, especially US-FDA and EU regulations.

Outstanding interpersonal, communication and negotiation skills.

Demonstrated leadership attributes; experienced at building and leading high performing teams; exemplifies corporate and ethical integrity; drives success consistent with company values and priorities.

Regulatory experience required with preference for therapeutic area experience in Medical Devices and Combination Products

Who We Are:

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions.  Our Vision is clear: A better and healthier every day for every woman.

US and PR Residents Only

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Organon is an Equal Opportunity Employer. We are committed to fostering a culture of inclusion, innovation, and belonging for all employees and job applicants. We ensure all employment practices are conducted without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, veteran status, or any other characteristic protected by state or federal law.

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Organon LLC., does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Applicable to United States Positions Only:  Under various U.S. state laws, Organon is required to provide a reasonable estimate of the salary range for this job.  Final salary determinations take a number of factors into account including, but not limited to, primary work location, relevant skills, education level, and/or prior work experience.  The applicable salary range for this position in the U.S. is stated below.  Benefits offered in the U.S. include a retirement savings plan, paid vacation and holiday time, paid caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.

Annualized Salary Range (US)

$125,400.00 - $213,100.00 Please Note: Pay Ranges are Specific to local market and therefore vary from country to country

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1