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Merck Organon - Executive Director, International CMC & Policy Lead in Pierre, South Dakota

Job Description

Reporting to the Head of Regulatory Chemistry, Manufacturing & Controls (CMC) Global Operations and Conformance, the Executive Director, International Regulatory CMC & Policy is responsible for influencing and managing the holistic regional Regulatory Chemistry, Manufacturing & Controls strategy and execution as a trusted global leader alongside Organon Research & Development, Manufacturing & Supply and Commercial colleagues. The International CMC & Policy Executive Director will be responsible for establishing, managing, and embedding regional regulatory CMC expertise across the entire Company's portfolio of small molecule, biologic and biosimilars, and serving as a regional leader, representing the Company's Regulatory CMC organization. He/she will ensure the Company's strategy is represented and called upon to influence key policy and regulatory decisions; and work with CMC key opinion leaders to ensure that new regulations are appropriately scientifically based.

The Executive Director, International CMC & Policy will manage a team of approximately 10-15 International CMC team members (internal/external) that act as the key CMC point of contact and Subject Matter Experts for CMC issues within the EEMEA, LATAM and APAC regions. He/she will engage with Country Regulatory Affairs, HQ CMC, Manufacturing, Supply Chain and Commercial leads, to ensure that CMC regulatory issues in the regions are appropriately understood, communicated, prioritized, and managed. He/she will work with CMC Franchise Leads to define and execute robust regional and country-specific regulatory strategies to ensure that the Company’s key CMC projects are successfully prosecuted in the international markets to enable compliant supply. Further the head of International CMC & Policy will be a key strategic partner for the Company's growth strategy including new product development, business development and licensing activity.

In addition, the Executive Director will represent the Company's Regulatory CMC in relevant trade associations and other forums and play a role in developing and communicating policy priorities internally and externally. In collaboration with the policy network across the Company, he/she will enable the organization to understand trends and changes as well as expectations of regulators and technology to address topics proactively. He/she, along with team members, will represent the Company in applicable external forums (e.g., PHRMA/BIO/EFPIA/IFPMA) and drive the Company’s position on key CMC topics. The individual will be required to develop and maintain an expert knowledge of Industry Association Whitepapers, Health Authority regulations & guidance documents.

Critical to this role is the ability to effectively recruit, manage and lead a diverse, global team of internal and external resources and the capability to flexibly allocate these resources to meet dynamic business priorities. The Executive Director will also be expected to contribute to organizational strategies and related projects on an as needed basis. He/she will be expected to represent the CMC organization needs and positions in senior leadership forums.

Responsibilities

Typical responsibilities of the role will include:

  • Collaborating with members of the International CMC & Policy team, the CMC product franchises, and others as relevant, the individual in this position will prioritize advocacy topics requiring attention, draft position papers and leverage them to influence stakeholders internally and externally. It is imperative that he/she work collaboratively with other key leaders in Regulatory CMC, Manufacturing & Supply, and Research & Development to ensure complete alignment. The individual will work closely with the functional leadership, develop and implement short and long term strategies by ensuring appropriate buy-in from all key stakeholders.

  • Development of CMC and related policy positions and advocating on behalf of Organon through industry associations or directly with Health Authorities.

  • Acting as liaison between Organon’s HQ CMC organization and the Country and Regional Regulatory Affairs organizations.

  • Interpretation of major regulatory developments in the EMEEA, LATAM and APAC regions, conducting impact assessments and defining implementation plans as required for broader dissemination within CMC and the wider organization.

  • Collaborate with Regulatory CMC leadership to influence and enable approaches for optimal global processes including regulatory change impact assessments for post-approval changes, and global CMC dossier administration for the international markets.

  • When required for priority projects, the Executive Director will directly contribute with CMC Product Leads and CMC Franchise Leads in the development and execution of critical submission strategies, submission components authoring, change control assessments, HA meeting background packages, and other regulatory CMC activities as required for the existing portfolio and new product development / business development & licensing activity in Organon.

  • Alignment on CMC priorities for the international markets, via consultation and agreement with Franchise leadership, Regional / Country regulatory affairs, HQ CMC and other stakeholders as appropriate.

  • Planning and co-ordination (at a high level) of major regional CMC submission projects that are key to Organon’s goals.

  • Working effectively with other stakeholders (Regional Regulatory Affairs Leads, Country Managing Directors, Manufacturing & Supply), to ensure that the company’s goals are effectively and efficiently achieved in compliance with CMC regulatory requirements.

  • Resolution of ad-hoc CMC requests and issues within the region, acting as point of escalation where appropriate.

  • Supporting and attending Health Authority meetings and discussions within the regions and liaising with international Health Authorities where necessary for Regulatory CMC and related topics (e.g. inspections, investigations).

  • Holds HR and line management responsibilities for the International CMC team (at multiple locations). Manages performance and prioritization of workload for team members, ensuring that objectives are being met.

Skills

  • Recognized as a CMC expert with broad global expertise in CMC/regulatory and change management activities across product registration and life-cycle management, as well experience in product development, manufacturing, or quality control/quality assurance.

  • The ideal candidate should have built a highly credible and significant external network and may have already garnered a reputation of endorsing external influence into a regulatory CMC organization.

  • Demonstrated ability to anticipate and influence internal/external business and regulatory environment to identify potential changes impacting business practices and proactively recommend process improvements to minimize compliance risk and enhance regulatory CMC operations.

  • Detail oriented leader with strong leadership/people management skills and exceptional interpersonal, collaboration and communication skills.

  • Demonstrated ability to interpret and apply diverse global/regional regulatory CMC requirements for development of compliant regulatory processes that effectively balance regulatory expectations with business needs.

  • Experience in leading Health Authority interactions and communication strategy development.

  • Proven track record in working and influencing multi-disciplinary teams with demonstrated leadership, communication, innovative problem solving and rapid, disciplined decision making, critical thinking capabilities, and ability to work well under pressure.

  • Exceptional interpersonal, verbal and written communication, presentation, and listening skills with a proven record of working with, and influencing, multi-disciplinary teams and external experts.

  • He/she will be expected to embody Organon values in their day-to-day activities and serve as an example by practicing them daily.

  • Demonstrated experience in building, rewarding, developing and retaining key talent.

Qualifications

  • The candidate must possess a degree in science (advanced degree preferred) with a minimum of fifteen (15) years of experience in the pharmaceutical industry.

  • A minimum of ten (10) years of CMC Regulatory Affairs experience with a track record of Regulatory CMC success for major projects in international markets.

  • Extensive network that includes regulators, industry colleagues and academicians.

  • A minimum of five (5) years of experience managing people. Experience in managing small team of contractors / outsourcing partners staff would be preferred.

  • Substantial experience in CMC regulatory affairs for small molecules (Drug substance, multiple drug product dosage forms) is an essential requirement. Experience of Biologics and Medical devices / combination products would be an advantage.

  • Ability to work independently and influence within a matrix structure.

  • A strong business acumen with a good understanding of the priorities and ways of working across commercial, manufacturing and supply chain.

  • Excellent written and verbal communication skills. The candidate must be proficient in English; additional language skills are a plus.

  • The candidate will be required to travel on a periodic basis.

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.

At launch, we will be more than 10,000 Founders strong, ready to rise together as we make a difference in a new way. As Founders, employees will create their future and will help shape the direction of Organon and its impact on the world. Our culture reflects our passion for those we champion.

At Organon, we all belong. We embrace diversity and give it a voice. Our commitment to supporting women is reflected in the make-up of our leadership team, which is majority female and our diversity of experience is core to who we are and what we are designed to do.

#NewCo

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/inst/1422$1533/rel-task/3001$14.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL [survey.sogosurvey.com]) if you need an accommodation during the application or hiring process.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster (https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf)

EEOC GINA Supplement​

OFCCP EEO Supplement (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf)

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, 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.

Employee Status:

Regular

Relocation:

Domestic/International

VISA Sponsorship:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Remote Work

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

Number of Openings:

1

Requisition ID: R105810

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