The Position
Reporting to the Chemistry Manufacturing & Controls (CMC) Senior Principal Scientist, International CMC (EU/EEMEA), the successful
Associate Principal Scientist
will 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.
They 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:
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, 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 escalate issues impacting product approval, launch or patient supplies 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.
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
Bachelors or Master’s Degree in chemistry, pharmacy, biology or a related science, with at least 5 years of experience in the pharmaceutical industry, in Regulatory Affairs and/or Technical Regulatory.
Minimum of 3 years’ experience in CMC Regulatory Affairs for biotechnology (preferred) or pharmaceutical products.
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.
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. 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
Minimum of 3 years’ experience in CMC Regulatory Affairs for biotechnology (preferred) or pharmaceutical products.
Direct Health Authority experience would be an advantage.
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.
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.
Search Firm Representatives Please Read Carefully Organon LLC does not accept unsolicited assistance from search firms for employment opportunities.
Annualized Salary Range
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Number of Openings:
1
Requisition ID:
R530856
#J-18808-Ljbffr
Reporting to the Chemistry Manufacturing & Controls (CMC) Senior Principal Scientist, International CMC (EU/EEMEA), the successful
Associate Principal Scientist
will 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.
They 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:
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, 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 escalate issues impacting product approval, launch or patient supplies 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.
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
Bachelors or Master’s Degree in chemistry, pharmacy, biology or a related science, with at least 5 years of experience in the pharmaceutical industry, in Regulatory Affairs and/or Technical Regulatory.
Minimum of 3 years’ experience in CMC Regulatory Affairs for biotechnology (preferred) or pharmaceutical products.
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.
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. 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
Minimum of 3 years’ experience in CMC Regulatory Affairs for biotechnology (preferred) or pharmaceutical products.
Direct Health Authority experience would be an advantage.
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.
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.
Search Firm Representatives Please Read Carefully Organon LLC does not accept unsolicited assistance from search firms for employment opportunities.
Annualized Salary Range
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Number of Openings:
1
Requisition ID:
R530856
#J-18808-Ljbffr
