Associate, 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.

Reaching People. Touching Lives.

Job Purpose

Prepare and file drug product submissions to the US FDA, Health Canada as well as to assist with global drug product registrations.

Duties And Responsibilities

• Prepare and / or review submissions to Health Canada and FDA for a variety of dosage forms (solid oral, liquids, topical semisolids and injectables) in eCTD format (e.g. DMFs, ANDS, NDS, ANDA, NDAs, S/NDSs, DINs, CTAs, NCs, INDs, provincial formulary submissions etc.) for the successful registration of drug products for domestic and international markets.
• Prepare submissions in eCTD format which involves full understanding of the use of Adobe Acrobat to create bookmarks and links.
• Prepare written responses to deficiency letters from regulatory agencies in the stated time frame.
• Prepare and file post approval submissions for FDA (CBE supplement, PAS) and TPD (Notifiable Change, Supplement).
• Maintain approved product monographs to comply with CRP-PMs.
• Maintain approved drug products for FDA (Annual Report) and TPD (Annual Drug Notification).
• Review and approve various product labeling components and marketing materials.
• Review internal documentation (master batch records, specifications, labeling, product monographs) for adherence to regulatory guidelines.
• Assist in global drug product registrations.
• Maintain current awareness of regulatory guidelines (Health Canada, FDA, ICH, European Medicines Agency - EMeA, MHRA, Therapeutic Goods Administration –TGA Australia, etc.).
• Other duties as required by the Manager.

Additional Responsibility (Only Applicable To Customer Facing Roles)

Report any adverse event received from customers for company products to the pharmacovigilance department / Drug Safety on the same day or within 1 business day

Qualifications

• Minimum B. Sc. in a Chemistry, Pharmacy or Life Science discipline combined with at least three (3) to five (5) years of relevant experience within a Canadian and / or USA Regulatory Affairs pharmaceutical environment.
• Strong working knowledge of current regulatory guidelines for FDA and / or TPD.
• Experience with eCTD submissions and knowledge of GMP and QA/QC procedures is preferred.
• Knowledge of the use of eCTD Software for preparing and filing submissions preferred.
• Strong organizational ability to maintain a complex and high volume of technical information up to date.
• Proficiency with applicable computer software – Microsoft Office including Word, Excel and PowerPoint and Adobe Acrobat and Document Management Systems.
• Excellent interpersonal, written and verbal communication skills.
• Ability to plan, coordinate and work effectively in a team-oriented environment.

Working conditions

• Multidisciplinary office, R&D and manufacturing environment
• Extensive use of computer
• Varied work schedule to meet deadlines, as required

Physical Requirements

Office based / Hybrid role

Direct reports

NA

This posting is for an existing vacancy.

The presently-anticipated base compensation pay range for this position is $66,000 to $82,500. 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.