Senior Manager, Regulatory Affairs

Driven by a bold pursuit of science and fueled by an unwavering commitment to patients, Sun Pharma is a leading global pharmaceutical company, providing high-quality medicines trusted by healthcare professionals and patients.

As part of our mission to Reach People and Touch Lives, we deliver Innovative Medicines, Generics and Consumer Healthcare products that improve the lives of millions of people. With a broadly diversified portfolio of products that span multiple therapeutic areas, we improve access to effective, affordable treatments that promote better health and well-being.

Job purpose

• To develop, implement, and execute a comprehensive regulatory strategy aligned with Health Canada’s regulatory requirements, guidelines, and applicable standards to ensure compliance and support successful regulatory submissions and approvals.
• Serve as a Regulatory Product Strategy Manager and provide CMC Regulatory leadership within the regulatory function and on cross functional teams for the assigned product being developed for the Canadian market.
• Lead strategic engagement with Health Canada to guide product development, support global regulatory registrations, and achieve optimal product labeling for one or more assets across therapeutic areas within the innovative portfolio.

Duties and responsibilities

• Provide strategic, tactical, and operational direction and guidance to product teams for assigned inline and/or pipeline assets in one or more therapeutic areas
• Responsible for developing, executing, and maintaining the regulatory requirements for assigned programs, as well as managing regulatory commitments
• Stay abreast of regulatory agency regulations, directives, guidelines, and policies that could impact product development, in order to assess approval pathways and identify potential issues
• Ensure lifecycle management through the timely submission of annual reports, supplements, etc., to maintain product continuity.
• The Product Strategy Manager is accountable for delivering all regulatory milestones for high-complexity products under their responsibility, including assessing the probability of regulatory success and implementing risk mitigation measures.
• Lead the development, communication, and review of the Regulatory Strategy Document for projects of increasing complexity.
• Provide regulatory leadership, as needed, in product in-licensing/due diligence reviews, product divestments, and product withdrawals.
• Manage the execution of regulatory documentation, including CTA, NDS, SNDS, pre-submission packages, and responses to health authority questions, in accordance with established business processes and systems.
• Set and monitor submission timelines in collaboration with key stakeholders.
• Coordinate with global manufacturing sites and integrate regulatory strategy across those sites.
• Provide consistent support to cross-functional teams such as commercial and clinical teams.
• Ensure communication with regulatory authorities is conducted in accordance with established departmental procedures.
• Participate in writing or facilitate the authoring of specific sections of product submission dossiers
• As applicable, review audit reports, regulatory agency inspection reports, and responses to inspection observations, if any, upon receipt
• Compiles, prepares, and reviews regulatory submissions to regulatory agencies, as applicable.
• Conduct department-level training, as necessary, to educate regulatory strategists and other roles within the department on regulatory requirements, policies, and procedures.
• Participate in the authoring and/or review of departmental procedures/guidance, as applicable
• Support new technology development within the company.
• Demonstrate an understanding of regulatory affairs and apply this knowledge to benefit the company by ensuring the approval and continued market supply of branded products worldwide.
• Conduct all activities with an unwavering focus on compliance.
• May be required to manage or mentor junior team members.

Qualifications

• Master’s degree preferred
• Minimum of 8-12 years of experience within global Innovative Medicine regulatory affairs in the pharmaceutical (ideally) or biotech industries is required
• Hands on expertise in preparation & review of dossiers, response to queries, communication with agencies for developed markets like Health Canada is required
• Direct experience authoring and filing clinical trial or marketing applications for Health Canada and a knowledge of the developing product regulations is required
• Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner.
• Strong listening skills
• This role needs a seasoned professional who is aware of the regulatory activities for NDS, post approval submissions, can work in R&D, CFT and who has the management capability of leading a group of team members.
• The candidate must be proficient in English; additional language skills are a plus.
• Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
• Demonstrated effective leadership, communication, interpersonal and negotiating skills

Working conditions

Hybrid role based out of Mississauga

Physical requirements

Hybrid role

Direct reports

NA

This posting is for an existing vacancy.

The presently-anticipated base compensation pay range for this position is $109,000 to $133,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; RRSP savings plan; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, ethnic origin, citizenship, ancestry, sex, age, marital status, family status, physical or mental disability, gender identity, gender expression or any other ground protected by applicable human rights legislation.

The Company uses artificial intelligence to screen, assess or select applicants.

Notice to Agency and Search Firm Representatives: Sun Pharmaceuticals Industries, Inc. (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Sun Pharma is committed to providing an inclusive and accessible recruitment process. Accommodation is available in accordance with applicable human rights and accessibility legislation throughout the recruitment and selection process. If you require accommodation at any stage of the process, please let us know and we will work with you to meet your needs. Information relating to accommodation requests will be treated confidentially.