Job Description
The Position Reporting to the Chemistry Manufacturing & Controls (CMC) Senior Principal Scientist, International CMC (EU/EEMEA), the successful Associate Principal Scientistwill be accountable for assessment of changes for regulatory impact, development of regional CMC strategy in EU/EEMEA, preparation of CMC documentation and execution of regional post-approval CMC supplements and new product registrations for the entire company portfolio of small molecule, biologic and biosimilars, serving as a link between Country Regulatory Affairs (CRA) team requirements and global CMC strategy to ensure right first-time submissions to Health Authorities.
You will work closely with CMC Product Leads to ensure that key CMC projects are successfully prosecuted in the region.
Responsibilities Bring energy, knowledge, innovation, and leadership to carry out the following:
The incumbent will be accountable for implementing regional CMC strategy for international markets for CMC life-cycle submissions with a focus on achieving right-first-time submissions, including the following activities:
For assigned product portfolio, develop robust CMC regional regulatory strategies for new marketing applications, Scientific Advice and post-approval changes, as appropriate.Working collaboratively with Global CMC Regulatory Affairs Product Leads, the team will ensure right first-time submissions, high approval rates, on target launches and successful implementation to maintain patient supplies throughout the products life-cycle.Ensure that the regional CMC regulatory strategy is aligned with the global regulatory strategy, Franchise portfolio, commercial and operational strategies and issues impacting product approval, launch or patient supplies will be appropriately escalated to CMC Regulatory Affairs Management.Boost Country RA affiliate interactions with their local Regulatory Agencies to facilitate Scientific Advice and the prompt review and approval of life-cycle submissions (as CMC content subject matter expert).Act as Regulatory CMC SME in regional post approval requirements, ensure awareness of regional regulatory policy trends and maintain/update the regulatory intelligence repository for EU/EEMEA markets, including communicating proactively with Global CMC Product Leads on regional registration requirements, new legislation and guidance and providing timely update of the CMC change management systems to promote right first-time submissions.Ensure high quality and timely responses to Regulatory Agency questions in EU/EEMEA markets and fulfilment of regulatory commitments to Regulatory Agency deadlines.Sponsor product compliance by ensuring local registrations and lifecycle management align with product manufacturing details.Drive continuous process improvement activities within the organization and participate in forums to ensure efficient processes and best practice.Influence CMC initiatives by internal and external engagement including trade associations and regulators to pursue priority advocacy plans impacting the business. Required Education, Experience, and Skills In order to excel in this role, you will more than likely have:
Possess a Bachelors or Master's Degree in chemistry, pharmacy, biology or a related science, with a minimum of 5 years of experience in the pharmaceutical industry, in Regulatory Affairs and/or Technical Regulatory.Minimum of 3 years' experience in CMC Regulatory Affairs forbiotechnology(preferred) or pharmaceuticalproducts. Experience in Regulatory Affairs for the EU/EEMEA markets, with a focus on Regulatory CMC requirements for small molecule/biologic/biosimilar products, development, manufacturing and/or quality assurance.Demonstrate effective problem solving, understanding of regulatory strategies, excellent interpersonal skills, detail oriented, and able to prioritize multiple tasks.Proven ability to convey effectively in both a written and verbal format. The ideal candidate will be fluent in 1-2 languages spoken in the region of responsibility, in addition to English.Ability to influence and work both freely and collaboratively in a team structure.Proven ability to work well under pressure. Preferred Education, Experience, and Skills - Direct Health Authority experience would be an advantage.
OCMC
Secondary Job Description 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. As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants. If you require reasonable accommodation(s) in completing an application, interviewing, or otherwise participating in the employee selection process, please email us at******. Search Firm Representatives Please Read Carefully
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. Annualized Salary Range Annualized Salary Range (Global) Employee Status:
RegularRelocation:
No relocationVISA Sponsorship: Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites
10%Flexible Work Arrangements: Shift: Valid Driving License: Hazardous Material(s): Number of Openings:
1
Requisition ID:R524459
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